Change in clinical management of patient with Type 1 diabetes, making study obsolete

In this within-subject cross-over study, the investigators hypothesize that corn-starch based supplements taken prior to exercise will decrease the risk of delayed hypoglycemia in adolescents with T1D, improve performance during exercise, and decrease glycemic variability during exercise.

Type 1 diabetes (T1D), one of the most common chronic diseases in adolescents, is caused by the destruction of insulin producing beta cells which are located in the pancreas. There are many factors that impact diabetes control which are insulin administration, intake of food and exercise. When an individual exercises, weight is better managed which allows for a better cardiovascular system. Exercising also improves insulin sensitivity which can increased the risk for delayed hypoglycemia (low blood sugar). Many individuals with T1D do not participate (or under-participate) in exercise due to the fear of hypoglycemia. This study will recruit adolescents with Type 1 diabetes to undergo a maximal exercise test to determine their VO2max. Study participants then will complete 2 exercise performance tests prior to which the participant will be randomized to consume 22 grams of either fast acting carbohydrates or long-acting cornstarch based supplements. Subjects will be asked to bike for 45 minutes (at 50% of VO2max) and then complete a 3.75 mile bike ride as quickly as possible. The investigators will document the time to completion of the bike ride as well as monitor glucose levels via continuous glucose monitoring for 12 hours after completion of the exercise test.

Inclusion Criteria:

• Age 12 - <18 year old male and female subjects with Type 1 diabetes for > 1 year
• HbA1c <10.5%
• Body Mass Index >10th % and <95th%
• Not being treated with sensor-augmented pump therapy
• Ability to participate in exercise activity - biking
• Willing to wear a continuous glucose monitor (CGM) sensor

Exclusion Criteria:

• Severe hypoglycemia (requiring glucagon or external assistance) in last 6 months
• Admission for diabetic ketoacidosis in last 3 months
• History of chronic lung disease, congenital heart disease or chronic asthma
• Food (including corn)/dye allergies
• Other chronic medical conditions except for well-controlled thyroid disease

All genders are eligible, patients self-identification of gender will be recorded

Consent informs subjects as follows:

If identifiers are removed from your identifiable information, that information could be used for future research studies or distributed to another investigator for future research studies without your additional informed consent. Any future use of the banked data for research outside the scope of this current protocol will be submitted as separate studies to the Institutional Review Board for review and approval, prior to conducting the research

Data will become available June, 2024 and will be available for 2 years

Contact with Principal Investigator