Type 1 diabetes Archives

Empowering Type 1 diabetes management with new technology

February 12, 2024

The iLet Bionic Pancreas was recently cleared by the U.S. Food and Drug Administration (FDA) and is now commercially available.

In 2021, Children’s National Hospital participated in a multi-center clinical trial to test the efficacy of the iLet Bionic Pancreas — a device that automatically regulates blood sugar levels in patients with Type 1 diabetes. The iLet Bionic Pancreas was recently cleared by the U.S. Food and Drug Administration (FDA) and is now commercially available.

“The bionic pancreas serves as an additional resource empowering patients to effectively manage their Type 1 diabetes with confidence,” says Fran Cogen, M.D., CDCES, director emerita of the Childhood and Adolescent Diabetes Program at Children’s National. “It requires minimal input from the patient.”

During initialization of the pump, patients will no longer need to enter carbohydrate amounts, just their weight. After the patient indicates whether they are having a usual meal, smaller than usual meal, or larger than usual meal, the device’s algorithms will adjust insulin doses automatically.

“Patients will not need to add correction insulin,” says Dr. Cogen. “There are 3 algorithms – one to adjust background insulin, one to adjust insulin needed to cover carbohydrates and one to adjust insulin needed to correct high blood sugars. The background insulin dosing will also be adjusted if the blood sugars decrease or become low.”

The FDA approved the iLet Bionic Pancreas for patients 6 years and older with Type 1 diabetes. Users will be required to pair the pump with a continuous glucose monitor as the pump is dependent on the monitor’s information. The results of the trial, primarily funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, were published in the New England Journal of Medicine.

Continuous glucose monitoring use patterns in young children after T1D diagnosis

November 1, 2022

Continuous glucose monitoring (CGM) is a blood glucose monitoring device worn on the body that is linked to positive glycemic outcomes in people with Type 1 diabetes

Continuous glucose monitoring (CGM) is a blood glucose monitoring device worn on the body that is linked to positive glycemic outcomes in people with Type 1 diabetes (T1D). However, very little research has examined CGM use and glycemic outcomes in young children, particularly those newly diagnosed with T1D.

A new Diabetes Technology and Therapeutics study led by Randi Streisand, Ph.D., C.D.C.E.S., Chief of Psychology and Behavioral Health at Children’s National Hospital, and others identified four meaningful trajectories of CGM use among young children across 18-months post-T1D diagnosis: those who “always” used CGM; those who got on CGM later but stayed on it (“late/stable”); those who used CGM inconsistently; and those who “never” used CGM. The investigators conducted a study of 157 parents of young children (1-6 years) newly diagnosed with T1D who enrolled in a behavioral intervention.

Importantly, the authors found that those with private insurance were more likely than those with only public insurance to be in the “always” and “late/stable” groups (as opposed to the “never” group). Those in the “always” and “late/stable” groups also had better glycemic outcomes than those in the “never group” at 18-months post-T1D diagnosis.

“This research highlights that insurance type can be a barrier to accessing CGM,” Dr. Streisand noted. “Further, this is one of the first studies, among newly diagnosed young children, to show that CGM initiation at diagnosis or near diagnosis followed by sustained use is associated with better glycemic outcomes compared to never initiating CGM, supporting findings from other studies conducted with older youth.”

The findings inform clinical care with patients as it suggests that, when clinically appropriate, CGM initiation near or at the time of diagnosis benefits glycemic outcomes in young children when followed by sustained use. This is the only study to examine patterns of CGM use among 1-6-year-old children newly diagnosed with T1D over the first 18-months post-diagnosis.

“It was exciting to find differences in glycemic outcomes based on CGM initiation and use in this unique population,” Dr. Streisand said. However, the authors concluded that, given the health benefits of CGM, further exploration of barriers to CGM access and use among some families is needed.

In addition to Dr. Streisand, other Children’s National co-authors include Carrie Tully, Ph.D.; Maureen Monaghan, Ph.D., C.D.E., and Christine Wang, Ph.D.

Multicenter trial finds bionic pancreas improves Type 1 diabetes management

September 29, 2022

Compared to other available artificial pancreas technologies, the bionic pancreas requires less user input and provides more automation because the device’s algorithms continually adjust insulin doses automatically.

A device known as a bionic pancreas, which uses next-generation technology to automatically deliver insulin, was more effective at maintaining blood glucose levels within normal range than standard-of-care management among people with Type 1 diabetes, a new multicenter clinical trial found.

The trial, conducted partly at Children’s National Hospital, was primarily funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, and published in the New England Journal of Medicine.

Automated insulin delivery systems – also called artificial pancreas or closed-loop control systems – track a person’s blood glucose levels using a continuous glucose monitor and automatically deliver the hormone insulin using a pump. These systems replace reliance on insulin delivery by multiple daily injections, pumps without automation and testing glucose levels using more labor-intensive systems, such as fingersticks.

“A diagnosis of Type 1 diabetes can be overwhelming for a child and their family,” said Fran Cogen, M.D., C.D.C.E.S., principal investigator at Children’s National and director of the Childhood and Adolescent Diabetes Program. “It is extremely important to monitor and manage glucose levels throughout the day to prevent serious complications like eye problems, kidney disease, heart and blood vessel disease. This new technology may give patients and families a sense of relief from some of the daily stressors that come with the diagnosis of this chronic disease.”

Compared to other available artificial pancreas technologies, the bionic pancreas requires less user input and provides more automation because the device’s algorithms continually adjust insulin doses automatically. Users of the bionic pancreas also do not have to count carbohydrates, nor initiate doses of insulin to correct for high blood glucose. In addition, healthcare providers do not need to make periodic adjustments to the device’s settings.

The 13-week trial, conducted at Children’s National and 15 other U.S. clinical sites, enrolled 326 participants ages 6 to 79 years who had Type 1 diabetes and had been using insulin for at least one year. Participants were randomly assigned to either a treatment group using the bionic pancreas device or a standard-of-care control group using their personal pre-study insulin delivery method.

The study found:

In participants using the bionic pancreas, glycated hemoglobin improved from 7.9% to 7.3%, yet remained unchanged among the standard-of-care control group.
The bionic pancreas group participants spent 11% more time within the targeted blood glucose range compared to the control group.
Results were similar in youth and adult participants.
Improvements in blood glucose control were greatest among participants who had higher blood glucose levels at the beginning of the study.

Hyperglycemia caused by equipment problems was the most frequently reported adverse event in the bionic pancreas group. The number of mild hypoglycemia events and frequency of severe hypoglycemia were not different in the two groups.

“The results of this study will bring hope to patients, families and providers that there are technologies being created to help ease the burden of diabetes management and keep glucose levels more stable,” said Kimberly Boucher, M.S.H.S., B.S.N., R.N., clinical research manager of Endocrinology at Children’s National.

The study is one of several pivotal trials funded by NIDDK to advance artificial pancreas technology and look at factors including safety, efficacy, user-friendliness, physical and emotional health of participants, and cost. To date, these trials have provided the important safety and efficacy data needed for regulatory review and licensure to make the technology commercially available. The Jaeb Center for Health Research in Tampa, Florida, served as coordinating center.

Funding for the study was provided by NIDDK grant 1UC4DK108612 to Boston University, by an Investigator-Initiated Study award from Novo Nordisk, and by Beta Bionics, Inc., which also provided the experimental bionic pancreas devices used in the study. Insulin and some supplies were donated by Novo Nordisk, Eli Lilly, Dexcom and Ascensia Diabetes Care. Partial support for the development of the experimental bionic pancreas device was provided by NIDDK SBIR grant 1R44DK120234 to Beta Bionics, Inc.

You can read the full study, Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes, in the New England Journal of Medicine.

Shideh Majidi, M.D., M.S.C.S, brings focus on psychosocial research in diabetes patients to Children’s National

March 14, 2022

Dr. Majidi specializes in Type 1 diabetes and has been involved in innovative research studying behavioral and psychosocial aspects of health care such as anxiety, depression and suicide and improving high-risk patient management for children with the disease.

Children’s National Hospital welcomes Shideh Majidi, M.D., M.S.C.S., as the new associate director of the Childhood and Adolescent Diabetes Program. Dr. Majidi specializes in Type 1 diabetes and has been involved in innovative research studying behavioral and psychosocial aspects of health care such as anxiety, depression and suicide and improving high-risk patient management for children with the disease.

Dr. Majidi comes to Children’s National from the Barbara Davis Center for Diabetes where, in addition to providing clinical care in the Pediatric Diabetes Division, she was the assistant professor of pediatric endocrinology, head of the depression screening and high-risk task force committees, developer and director of an online class for children managing their Type 1 diabetes and a member of several committees focusing on program evaluation and residency and fellowship recruitment.

When Andrew Dauber, M.D., M.M.Sc., took over the role of division chief of Endocrinology, his goal was to create a clinical endocrinology research program to provide cutting-edge treatment for families. Dr. Dauber is excited to have Dr. Majidi bring her expertise to the team to further this goal. “Dr. Majidi has played a key role in national cooperative research on quality improvement in pediatric diabetes care and is now leading an international collaborative focused on preventing suicide in individuals with Type 1 diabetes,” says Dr. Dauber. “Her compassion, intellect and commitment to improving care for all children with diabetes is an inspiration to us all.”

Dr. Majidi will continue to serve in her roles as site co-lead for Type 1 Diabetes Exchange Quality Improvement Collaborative, where she recently led a 2021 study exploring inequities in access to and outcomes of health care for those with Type 1 diabetes, and co-chair for RESCUE, which aims to reduce suicide rates among individuals with diabetes.

She is dedicated to meeting patients and families where they are to help provide the best care. “We may think we see a lack of effort in diabetes care from patients and families, but we need to reframe our mindset and dig deeper to determine what barriers are in the way of diabetes management– behavioral, psychosocial or otherwise,” says Dr. Majidi. “When we do this, we can then work on how to help families manage and overcome the barriers that affect their diabetes care.”

Diabetes technology use in the cystic fibrosis community

November 26, 2021

insulin pump

Although diabetes technologies are associated with improvements in glycemic control and health-related quality of life among people with type 1 diabetes (T1D), the use and perceptions of continuous glucose monitors (CGM) and insulin pumps within the cystic fibrosis (CF) community have not been well documented.

In a recent study published in Diabetes Technology & Therapeutics, Brynn Marks, M.D., MS-HPEd, and co-authors, found that compared to T1D, rates of sustained diabetes technology use in the cystic fibrosis-related diabetes (CFRD) community are low, despite perceived benefits. The authors conclude that better insurance coverage to mitigate cost, better patient education and confirmation that these technologies improve health and patient-reported outcomes may increase uptake.

Read the full article in Diabetes Technology & Therapeutics.

Patterns of continuous glucose monitoring use in young children after T1D diagnosis

August 4, 2021

The findings suggest that, when clinically appropriate, continuous glucose monitoring initiation near or at the time of diagnosis benefits glycemic outcomes in young children when followed by sustained use.

Continuous glucose monitoring (CGM) is a blood glucose monitoring device worn on the body that is linked to positive glycemic outcomes in people with Type 1 diabetes (T1D). However, very little research has examined CGM use and glycemic outcomes in young children, particularly those newly diagnosed with T1D.

A new Diabetes Technology and Therapeutics study led by Randi Streisand, Ph.D., C.D.C.E.S., Chief of Psychology and Behavioral Health at Children’s National Hospital, and others identified four meaningful trajectories of CGM use among young children across 18-months post-T1D diagnosis: those who “always” used CGM; those who got on CGM later but stayed on it (“late/stable”); those who used CGM inconsistently; and those who “never” used CGM. The investigators conducted a study of 157 parents of young children (1-6 years) newly diagnosed with T1D who enrolled in a behavioral intervention.

Importantly, the authors found that those with private insurance were more likely than those with only public insurance to be in the “always” and “late/stable” groups (as opposed to the “never” group). Those in the “always” and “late/stable” groups also had better glycemic outcomes than those in the “never group” at 18-months post-T1D diagnosis.

“This research highlights that insurance type can be a barrier to accessing CGM,” Dr. Streisand noted. “Further, this is one of the first studies, among newly diagnosed young children, to show that CGM initiation at diagnosis or near diagnosis followed by sustained use is associated with better glycemic outcomes compared to never initiating CGM, supporting findings from other studies conducted with older youth.”

The findings inform clinical care with patients as it suggests that, when clinically appropriate, CGM initiation near or at the time of diagnosis benefits glycemic outcomes in young children when followed by sustained use. This is the only study to examine patterns of CGM use among 1-6-year-old children newly diagnosed with T1D over the first 18-months post-diagnosis.

“It was exciting to find differences in glycemic outcomes based on CGM initiation and use in this unique population,” Dr. Streisand said. However, the authors concluded that, given the health benefits of CGM, further exploration of barriers to CGM access and use among some families is needed.

In addition to Dr. Streisand, other Children’s National co-authors include Brynn Marks, M.D., M.S. HPEd.; Carrie Tully, Ph.D.; Maureen Monaghan, Ph.D., C.D.E. , and Christine Wang, Ph.D.

Study examines severity of COVID-19 on kids with Type 1 diabetes

May 11, 2021

A new study published in the Journal of Diabetes, found that although nearly 80% of youth with Type 1 diabetes and COVID-19 infection are managed at home, youth from racial and ethnic minority groups – those with higher hemoglobin A1c values – and those with public insurance are at increased risk for hospitalization.

In a new study published in the Journal of Diabetes, researchers found that although nearly 80% of youth with Type 1 diabetes (T1D) and COVID-19 infection are managed at home, youth from racial and ethnic minority groups – those with higher hemoglobin A1c values – and those with public insurance are at increased risk for hospitalization. Most hospitalizations among these youth were related to diabetic ketoacidosis (DKA) (72%) and 86% of youth hospitalized had an A1c value over 9%. The increased risk for DKA among racial and ethnic minority groups and publicly insured youth in this study is indicative of disparities in T1D outcomes and aligns with other research findings both before and during the pandemic.

Adults with certain underlying medical conditions, like diabetes, are at an increased risk for severe illness from COVID-19. Though there are limited data on youth with T1D who have been infected with COVID-19, viral infections can make it harder to control blood glucose levels. If not properly managed, infections may lead to DKA, a serious life-threatening condition where the body converts fat instead of sugar into energy, causing ketones to build up in the blood and acid levels to rise.

“There is still more to learn about COVID-19 and how it affects children with diabetes and other underlying medical conditions,” said Brynn Marks, M.D., MS-HPEd, pediatric endocrinologist at Children’s National Hospital and one of the study’s co-authors. “We are hopeful that this latest data will emphasize the importance of optimizing glycemic control and give physicians and families more information about the virus and T1D so that severe illness and hospitalizations can possibly be prevented.”

In April 2020, the T1D Exchange Quality Improvement Collaborative, along with endocrinology clinics across the U.S., formed a COVID-19 clinical registry to better understand symptoms and outcomes of patients with T1D who also tested positive for SARS-CoV-2 infection. More than 46 centers nationwide, including Children’s National Hospital, submitted data to this novel registry of 266 youth under the age of 19 with previously established T1D and laboratory confirmed COVID-19.

The study found that nearly 80% of youth with T1D and known COVID-19 infection were cared for at home without any adverse outcomes. It is also important to note that COVID-19 was incidentally discovered in 16% of hospitalized youth admitted for reasons unrelated to COVID-19 or T1D (e.g. urological procedures, psychiatric admissions). However, the data revealed a disproportionate rate of hospitalizations and DKA among racial and ethnic minority groups, children who were publicly insured and those with higher A1c. Out of the 266 patients, 72% of the 61 patients were hospitalized due to DKA. An overwhelming majority (82%) of hospitalized patients had an A1c value greater than 9%. More than 40% of non-Hispanic Black youth in the study were hospitalized as compared to 14% of non-Hispanic white youth. Researchers also noted that those patients with public insurance were less likely to use insulin pumps and continuous glucose monitors, emphasizing the continued need to improve more access to diabetes technologies.

“Diabetes technology has advanced rapidly in the last decade and access to insulin pumps and continuous glucose monitors is improving, however these technological advances are perpetuating pre-existing disparities in T1D care and outcomes,” Dr. Marks said. “The data is clear and there is a pressing need to act to promote optimal care for all people with T1D.”

Recently, Dr. Marks and the Children’s National Diabetes team became official members of the Type 1 Diabetes Exchange Collaborative. The team looks forward to using the opportunity to improve diabetes care both here at Children’s National and across the country.

There’s still more to learn about COVID-19 and diabetes

February 8, 2021

boy checking his blood glucose

Researchers have learned a lot about COVID-19 over the past year and are continuing to learn and study more about this infection caused by the SARS-CoV-2 virus. There have been many questions about whether COVID-19 affects people with diabetes differently than those without and why this might occur.

Diabetes experts, like Brynn Marks, M.D., M.S.H.P.Ed., endocrinologist at Children’s National Hospital, have been studying the relationship between COVID-19 and diabetes, especially in the pediatric population. Dr. Marks tells us more about what we know so far and further research that needs to be done when it comes to COVID-19 and diabetes.

1. What do we know about COVID-19 and its effect on people with known diabetes?

The Centers for Disease Control and Prevention (CDC) currently lists type 2 diabetes (T2D) as a high risk condition for severe illness related to COVID-19 infection, while stating that adults with type 1 diabetes (T1D) might be at increased risk. A recent study from Vanderbilt University found that people with T1D and T2D were at approximately equal risk for complications of COVID-19 infection. As compared to adults without diabetes, adults with T1D and T2D were 3-4 times more likely to be hospitalized and to have greater illness severity. Given these comparable risks, both the American Diabetes Association and the Juvenile Diabetes Research Foundation are lobbying for adults with T1D to be given the same level or priority for COVID-19 vaccines as adults with T2D.

However, as pediatricians, we all know to be wary of extrapolating adult data to pediatrics. Children are less likely to be infected with COVID-19 and if they are, the clinical course is typically mild. To date, there have not been any studies of the impact of COVID-19 on youth with known T2D. Our clinical experience at Children’s National Hospital and reports from international multicenter studies indicate that youth with T1D are not at increased risk for hospitalization from COVID-19 infection. However, paralleling ongoing disparities in T1D care, African Americans with known T1D and COVID-19 infection were more likely to be develop diabetic ketoacidosis (DKA) than their White counterparts.

With the increased use of diabetes technologies, including continuous glucose monitors, insulin pumps and automated insulin delivery systems, diabetes care lends itself well to telemedicine. Studies from Italy during the period of lockdown showed better glycemic control among youth with T1D. Further studies are needed to better understand the implications of telehealth on diabetes care, particularly among those in rural areas with limited access to care.

Diabetes experts, like Brynn Marks, M.D., M.S.H.P.Ed., endocrinologist at Children’s National Hospital, have been studying the relationship between COVID-19 and diabetes, especially in the pediatric population.

2. What do we know about the impact of the COVID-19 pandemic on children with newly diagnosed diabetes?

Nationwide studies from Italy and Germany over the first few months of the pandemic found no increase in the incidence of pediatric T1D during the COVID-19 pandemic as compared to the year before; in fact, the Italian study found that fewer children were diagnosed with T1D during the pandemic. However, many centers are seeing higher rates of DKA and more severe DKA at diagnosis during the pandemic, possibly due to decreased primary care visits and/or fears of contracting COVID-19 while seeking care.

To date, no studies have been published exploring the incidence of T2D in youth. A group from Children’s National, including myself, Myrto Flokas, M.D., Abby Meyers, M.D., and Elizabeth Estrada, M.D., from the Division of Endocrinology and Randi Streisand, Ph.D., C.D.C.E.S. and Maureen Monaghan, Ph.D., C.D.C.E.S., from the Department of Psychology and Behavioral Health, are gathering data to compare the incidence of T1D and T2D during the pandemic as compared to the year before.

3. Can COVID-19 cause diabetes to develop?

This has been area of great interest, but the jury is still out. The SARS-CoV-2 virus, which causes COVID-19 infection, binds the angiotensin-converting enzyme 2 (ACE2) receptor which is located in many tissues throughout the body, including the pancreas. SARS-CoV-2 has been shown to infect pancreatic tissue leading to impaired glucose stimulated insulin secretion. Although the SARS-CoV-2 virus could plausibly cause diabetes, assessment has been complicated by many confounders that could be contributing to hyperglycemia in addition to or rather than the virus itself. Stress-induced hyperglycemia from acute illness, the use of high dose steroids to treat COVID-19 infection, and the disproportionate rates of infection among those already at high risk for T2D, as well as weight gain due to changes in day-to-day life as a result of social distancing precautions are all likely contributing factors.

Children’s National to test bionic pancreas

January 20, 2021

The iLet bionic pancreas helps patients manage their diabetes by both monitoring blood glucose levels and administering insulin and glucagon.

The final results of this clinical trial were published on September 29, 2022 in the New England Journal of Medicine.

Children’s National Hospital has been selected to participate in a multi-center clinical trial to test the efficacy of the iLet bionic pancreas — a device that automatically regulates blood sugar levels in patients with Type 1 diabetes.

Patients generally manage diabetes by constantly monitoring their blood sugar levels and administering insulin when necessary. Unfortunately, too much insulin can cause hypoglycemia, or low blood sugar, which can result in hypoglycemic seizures, coma or rarely, death. Thus, it is extremely important for people with diabetes to regulate their insulin dosages and maintain their blood sugar levels within a range decided by the family and diabetes team.

“The burden of caring for diabetes on a daily basis is grueling,” says Seema Meighan, FNP, a nurse practitioner involved in the upcoming clinical trial. “It is by far one of the most challenging chronic diseases to manage, and requires vigilant participation 100 percent of the time to stay well controlled.”

The iLet bionic pancreas helps patients manage their diabetes by both monitoring blood glucose levels and administering insulin and glucagon — a pancreatic hormone that raises blood sugar levels.

“In a traditional infusion pump, patients only have access to insulin to control glucose levels,” explains Meighan. “This can become problematic when it comes to hypoglycemia. The hope with a bi-hormonal system is that glucagon can be delivered during times that the glucose is low in order to stabilize levels without user interaction.”

Developed at Boston University by Edward Damiano, Ph.D., and Firas El-Khatib, Ph.D., the iLet is a hand-held device about the size of an iPhone but twice as thick, and can easily fit into a pocket. The unit consists of a dual chamber infusion pump that can be configured to deliver only insulin, only glucagon or both hormones. The device uses a wireless glucose sensor on the patient’s body to test blood sugar levels every five minutes. It then determines which hormone is needed and administers it via catheters connected to the patient.

In short-term studies, the iLet was able to maintain blood glucose levels close to normal in both adults and children in carefully controlled environments.

In 2016, the Children’s National Hospital Division of Endocrinology and Diabetes, led by diabetologist Fran Cogen, M.D., C.D.C.E.S., was one of several pediatric sites that were selected to participate in pivotal clinical trials to further test the efficacy of the bionic pancreas. In June 2020, the team at Children’s National began enrolling patients to test iLet devices that only deliver insulin. Once these initial studies are completed, the team will perform an additional trial to test iLet devices configured to deliver both insulin and glucagon.

“This trial is important as it represents the first dual chamber pump to manage glucose levels,” says Meighan. “It could potentially change the way we treat diabetes entirely. It represents a hope to our patients and families that one day this disease will have far less of a daily burden than it currently does.”

Currently, there are 18 patients enrolled in the clinical trial. An initial test run on two patients was successfully completed in November 2020. In early January 2021, the first patient was started on the bionic pancreas to begin the randomized controlled study and three additional patients, who completed the screening process, will join the study shortly. The screening and initiation of the study will continue in the remaining patients.

Improving glycemic control in diabetic children

June 10, 2019

A 10-week pilot study at Children’s National Health System integrated weekly caregiver coaching, personalized glucose monitoring and incentives into standard treatment for 25 pediatric patients with type 1 diabetes, lowering A1c by .5%

The life of a type 1 diabetes patient – taking daily insulin shots or wearing an insulin pump, monitoring blood sugar, prioritizing healthful food choices and fitting in daily exercise – can be challenging at age 5 or 15, especially as holidays, field trips and sleepovers can disrupt diabetes care routines, creating challenges with compliance. This is why endocrinologists from Children’s National Health System experimented with using health coaches over a 10-week period to help families navigate care for children with type 1 diabetes.

By assembling a team of diabetes educators, dietitians, social workers, psychologists and health care providers, Fran Cogen, M.D., C.D.E., director of diabetes care at Children’s National, helped pediatric patients with type 1 diabetes manage their glycemic status, or blood-sugar control.

On Saturday, June 8, 2019, Dr. Cogen will share results of the pilot program as poster 1260-P, entitled “A Clinical Care Improvement Pilot Program: Individualized Health Coaching and Use of Incentives for Youth with Type 1 Diabetes and their Caregivers,” at the American Diabetes Association’s 79th Scientific Sessions, which takes place June 7-11 at the Moscone Center in San Francisco.

Dr. Cogen’s study was offered at no cost to caregivers of 179 patients at Children’s National seeking treatment for type 1 diabetes. The pilot program included two components: 1) Weekly phone calls or emails from a health coach to a caregiver with personalized insulin adjustments, based on patient blood sugars submitted through continuous glucose monitoring apps; and 2) Incentives for patients to participate in the program and reach health targets.

Twenty-five participants, ages 4-18, with a mean age of 11.6 and A1c ranges between 8.6 – 10% joined the study. The average A1c was 9.4% at the beginning of the program and dropped by an average of .5% at the end of the trial. Twenty of the 25 participants, 80%, improved A1c levels by .5%. Seventeen participants, 68%, improved A1c levels by more than .5%, while seven participants, 28%, improved A1c levels by more than 1%.

“Chronic disease is like a marathon,” says Dr. Cogen. “You need to have constant reinforcement and coaching to get people to do their best. Sometimes what drives people is to have people on the other end say, ‘Keep it up, you’re doing a good job, keep sending us information so that we can make changes to improve your child’s blood sugar management,’ which gives these new apps and continuous glucose monitoring devices a human touch.”

Instead of waiting three months between appointments to talk about ways a family can make changes to support a child’s insulin control and function, caregivers received feedback from coaches each week. Health coaches benefitted, too: They reported feeling greater empathy for patients, while becoming more engaged in personalizing care plans.

Families who participated received a gift card to a local grocery store, supporting a child’s dietary goals. Children who participated were also entered into an iPad raffle. Improvements in A1c levels generated extra raffle tickets per child, which motivated participants, especially teens.

“These incentives are helpful in order to get kids engaged in their health and in an immediate way,” says Dr. Cogen. “Teenagers aren’t always interested in long-term health outcomes, but they are interested in what’s happening right now. Fluctuating blood sugars can cause depression and problems with learning, while increasing risk for future complications, including eye problems, kidney problems and circulation problems. As health care providers, we know the choices children make today can influence their future health outcomes, which is why we designed this study.”

Moving forward, Dr. Cogen and the endocrinologists at Children’s National would like to study the impact of using this model over several months, especially for high-risk patients, while asynchronously targeting information to drive behavior change – accommodating the needs of families, while delivering dose-specific recommendations from health care providers.

Dr. Cogen adds, “We’re moving away from office-centric research models and creating interventions where they matter: at home and with families in real time.”

Read more about the study at Healio.com and dLife.

Additional study authors, all of whom work within the division of diabetes and endocrinology at Children’s National, include Lauren Clary, Ph.D., Sue-Ann Airborne, C.D.E., Andrew Dauber, M.D., Meredith Dillon, R.D., L.D.N., C.D.E., Beakel Eshete, B.S.N., R.N., C.D.E., Shaina Hatchell, B.S.N., R.N., Shari Jones, R.N., C.D.E., and Priya Vaidyanathan, M.D.

Thirteen questions for a pediatric endocrinologist

December 27, 2018

Andrew Dauber, M.D., hosts an AMA chat with Reddit’s science community and offers feedback about height, growth disorders and pediatric endocrinology.

Andrew Dauber, M.D., MMSc., the division chief of endocrinology at Children’s National, spoke about epigenetics – how genes are expressed – and about all things related to pediatric endocrinology in a recent Ask Me Anything (AMA) chat with Reddit’s science community.

We’ve selected highlights from several questions Dr. Dauber received. You can view the full AMA discussion on Reddit.

Q1: What will the future of type 1 diabetes treatment look like?

As a pediatric endocrinologist, Dr. Dauber sees a lot of patients with type 1 diabetes. He predicts technology will pave the way for advancements with continuous glucose monitoring and encourage a ‘real-time’ interaction between patients and providers:

“I anticipate that within a few years, everyone will have access to continuous glucose monitoring technology and that these will be seamlessly connected to insulin pumps or artificial pancreas technologies,” types Dr. Dauber in response to the first AMA question. “I also think there will be more virtual interaction between medical providers and patients with doctors and nurses reviewing blood sugar data in the cloud.”

Q2: What height range is considered normal for a growing child? What is the difference between short stature and a height problem?

The Centers for Disease Control and Prevention has a growth chart, which shows ‘normal’ ranges, based on statistical definitions of height in the general population.

“The truth is that I know plenty of people who have heights below the ‘normal’ population, and they don’t think they have a problem at all,” says Dr. Dauber. “From a genetics point of view, the question can be reframed: When do we call a genetic variant a ‘mutation’ versus a rare variant in the population? For example: If there is a genetic change that 1 in a 1,000 people have that causes you to be 2 inches shorter – is that a problem? Is that a disease?”

“From a clinical perspective, I tend to have a discussion with my patients and their families and ask them how their stature is affecting their lives and whether changing that would really make a meaningful difference,” adds Dr. Dauber. “I believe that this is a very personal decision but people need to be realistic about expected outcomes.”

Q3: What are your favorite case studies about atypical growth or height patterns?

Dr. Dauber references two case studies about growth and puberty:

The growth case study refers to the PAPPA2 gene, which was particularly meaningful for Dr. Dauber since he got to know the family and was able to provide answers to a previously undiagnosed medical mystery about short stature. This research is also opening future studies and analysis about the regulation of IGF-1 bioavailability.

The puberty case study looks at the opposite end of growth and development: precocious puberty. In this case an inherited MKRN3 gene mutation resulted in new insight about the regulation of pubertal timing: Deficiency of MKRN3 caused central precocious puberty in humans. Girls who had inherited the mutated genes from their father (an imprint gene) started to develop breasts before age 6. The results were published in The New England Journal of Medicine.

Q4: What are the differences with consistent and inconsistent growth disorders? Could one arm or leg experience accelerated or stunted growth?

“Most genetic disorders that affect growth will have a uniform effect throughout the body as they are likely to affect all aspects of the skeleton,” says Dr. Dauber. “That being said, there are some notable exceptions such as Russell-Silver syndrome which presents with body asymmetry. There are also somatic mutations (mutations which are just present in some cells in the body) that can lead to segmental areas of overgrowth leading to asymmetry.”

Q5: Can you predict height and growth by looking at genetic factors? What are your thoughts about polygenic risk scores?

“Polygenic risk scores will probably play more of a role in the future to help determine risk of a certain disease,” says Dr. Dauber. “Right now, for most conditions, the risk score does not explain a substantial enough fraction of the variation to help with prediction.”

Dr. Dauber discusses how this works for height, a highly hereditable trait, in The Journal for Clinical Endocrinology and Metabolism. In the review, Dr. Dauber and the study co-authors note that individuals with extreme heights are more likely to have abnormal stature as a result of a severe mutation that causes a growth disorder. For these individuals, whole exome sequencing may reveal gene mutations.

However, the study authors note that for now, the role of these technologies in individuals with extreme stature but without any syndromic features has not been rigorously and systematically explored. (Dr. Dauber and a team of endocrinologists from leading children’s hospitals are currently using electronic health records to study and track these types of genetic clues over time.)

Q6: The general public is excited about genetics and ongoing research, especially with consumer applications – such as genetic tests, including 23andMe. What misconceptions about genetics do people have? What ethical concerns do geneticists share right now?

“Many people think that genetics is completely deterministic,” says Dr. Dauber. “In reality, most genetic variants influence a person’s predisposition toward a trait or disease but don’t actually determine the outcome. Also, the genetic sequence itself is just the first step. Epigenetics, gene regulation, and gene-environment interactions are all important and we are just scratching the surface of understanding these areas.”

“I think that people engaged in genetics research are very interested in the ethical questions,” adds Dr. Dauber. “The problem is that technology is advancing at such a rapid pace, that often consumers are using technologies in ways that we haven’t yet had time to figure out the ethics for. The medical community is often playing catch up.”

Q7: Aside from using gene modifications to cure diseases, where or when should we draw the line in terms of enhancement?

“I think genetic modification for enhancement is a very dangerous slippery slope that we should avoid,” says Dr. Dauber. “We really don’t know the full effect of many genes and by enhancing them, we could be causing lots of problems that we can’t anticipate. There is a reason that evolution is a slow process that happens over millions of years. I think we need to start with the most devastating diseases and try to cure those first.”

Q8: Would it be ethical to use CRISPR on the genes for short stature to produce tall offspring if the risks are sufficiently small? This would be similar to what Dr. He did, but without the ethical violations.

“This is a fascinating question and it will become more of an issue over time,” says Dr. Dauber. “Where do we draw the line between fixing, preventing disease and enhancing physical function? Personally, I think using genome editing to promote height is a terrible idea. Our current perception that taller height is more desirable is a social construct and varies by culture. This idea also changes over time.”

Q9: Overall, how does this fit into meeting unmet medical needs?

“I would be very wary about trying to design our children’s physical features,” Dr. Dauber notes. “We need to figure out as a society what diseases are sufficiently problematic that we feel comfortable trying to eliminate them via genome editing.”

Q10: How many genes control acromegaly? Is it possible (in theory) to Top of Formselect them just to gain the positive effects of gigantism without the health risks?

Dr. Dauber explains that acromegaly, a condition often referred to as gigantism, is caused by a growth hormone-producing tumor. There are a few genes known to cause these tumors, including the AIP, and there was recently a genetic cause of X-linked gigantism, which was published in The New England Journal of Medicine.

“This basic idea is a good one,” notes Dr. Dauber. “We can find genes that when mutated can cause tall stature – and then try to manipulate those pathways. A great example is the NPR2 gene, which when mutated can cause short or tall stature. This pathway is being targeted for therapeutics related to achondroplasia.”

The National Institutes of Health (NIH) refers to achondroplasia as ‘short-limbed dwarfism,’ which results in an average-sized trunk with short limbs, especially arms and legs, due to a lack of cartilage turning into bone. The average height of an adult male with achondroplasia is 4 feet, 4 inches, while the average height of adult females with achondroplasia is less than 4 feet, 1 inch. In this case, manipulating growth pathways may help alleviate health problems associated with achondroplasia: lack of mobility or range of motion, an enlarged head, apnea, ear infections and spinal stenosis, or a compression or pinching of the spinal cord.

Q11: Give us a history lesson. Why are there variations of height within populations, such as Asia and Latin America?

“The average height in a population is due to the influence of literally thousands of common genetic variants,” says Dr. Dauber. “These population differences have evolved over thousands of years due to a combination of migration and selection. There is a well-known difference in the genetic makeup of various populations which likely underlies the differences across the globe. There are even differences within Europe.”

Q12: Are there examples of pseudoscience or theories about growth, such as recommendations to eat a certain food instead of taking growth hormones to correct for a growth disorder, which runs contrary to scientific evidence, that drive you crazy?

“I don’t really get bothered by crazy theories, but it is upsetting when patients and their families get swindled into spending their money on therapies that aren’t truly effective,” says Dr. Dauber. “People ask me all the time if a certain food or exercise can make their child taller. The bottom line is that in a well-nourished (and healthy) child, there is no magical food that is going to make them tall.”

Q13: According to almost every theory of how life evolved on Earth, from religion to evolution, we all have one common ancestor. In theory doesn’t that make us all cousins?

“Yes, just very distant ones,” says Dr. Dauber. “People always point out the vast number of differences between races but in fact we are all more than 99.9 percent identical on a genetic level.”

Stay on top of the latest pediatric endocrinology news by following @EndoDocDauber and @ChildrensHealth on Twitter: #GrowUpStronger.

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