Type 1 diabetes mellitus (T1D) continues to impose a considerable public health burden. Average HbA1c among youth in the US in 2016 was 8.8%, considerably above the standard clinical target of < 7.5%, and had worsened significantly since 2011. Inadequate glycemic control is a major contributor to excess morbidity, yet interventions studied to date have mixed or limited effects. Relevant to the current proposal, the emphasis of the last two decades on flexible patterns of dietary intake for youth with T1D has clearly not corresponded with adequate glycemic control, despite increased use of insulin pumps and continuous glucose monitoring (CGM) in that time period. Thus, there are major gaps in knowledge about what interventions might achieve improved glycemic control, and what approach to patterns of dietary intake might be beneficial. Some major T1D clinical practice guidelines explicitly recommend use of structured eating patterns, including the International Society for Pediatric and Adolescent Diabetes (ISPAD), whereas the American Diabetes Association (ADA) nutrition guidelines do not. Remarkably, there are no clinical trial data on the effectiveness of structured eating patterns for youth with T1D to improve glycemic control throughout the day. Thus, our overarching goal is to rigorously test the effectiveness of individualized, structured eating patterns to improve glycemic control throughout the day, in order to inform T1D clinical practice guidelines. We have completed several preliminary studies that support the likely acceptability and effectiveness of an individualized structured eating plan intervention we called ?MyPlan?, that includes collaborative development of the individualized structured eating plan to spread intake of carbohydrate and calories over the day. Here we propose a pilot single arm clinical trial to inform a future, fully powered pragmatic trial of the addition of individualized structured eating plans to ongoing diabetes care in clinical settings.
Our Specific Aims are:
Aim 1. Assess acceptability and adherence to a 6-month individualized structured eating intervention (?MyPlan?) among 40 youth with T1D. We will recruit adolescents, age 12-17 years, with T1D of at least 1-year duration and with HbA1c >8 % and <11% (total n=50 recruited to ensure n=40 active participants across two clinical sites) to participate in a 6-month MyPlan intervention, which will guide participants in setting behavioral goals in relation to five tenets that comprise a structured eating pattern.
Aim 2. Compare glycemic control among adolescents with T1D at baseline and at the end of the 6-month MyPlan intervention. Measures of glycemic control will include % time in range (TIR) based on continuous glucose monitoring and HbA1c. Our team has worked together for many years and is well positioned to conduct this critical work that will inform how medical nutrition therapy is approached for youth with T1D.
Among youth with type 1 diabetes, poor glycemic control is common and contributes substantially to risk for serious complications of the disease. Inconsistent patterns of dietary intake throughout the day may make glycemic control harder to accomplish compared to consistent patterns of intake that spread carbohydrate and calories over the day, yet no clinical trial data are available to test this hypothesis. The proposed pilot single arm clinical trial of individualized structured eating plans will inform the design of a larger, fully powered clinical trial to address this critical clinical question and inform clinical practice guidelines.
