Hypoglycemia, Type 1 Diabetes
Conditions
Keywords
adolescent, exercise, cgm
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTsuper starch
Pre-exercise carbohydrate, slow-acting
DIETARY_SUPPLEMENTmaltodextrin
Pre-exercise carbohydrate, fast-acting
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Within subject, randomized cross-over study
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of hypoglycemic events 12 hours after completion of exercise challenge | 12 hours after exercise challenge | Review of continuous glucose monitoring data |
| Glycemic variability during exercise challenge | During exercise challenge | Review of continuous glucose monitoring data |
| Time to completion of distance bike challenge | During exercise challenge | Number of minutes to complete 3.75 mile bike ride |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent time spent in hypoglycemia following exercise challenge | 12 hours after exercise challenge | Review of continuous glucose monitoring data |
| Percent time above range, in range, and below range following exercise challenge | 12 hours after exercise challenge | Review of continuous glucose monitoring data |
| Glycemic variability in the 12 hours following the exercise test | 12 hours after exercise challenge | Review of continuous glucose monitoring data |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLucy Mastrandrea, MD, PhD
State University of New York at Buffalo
Outcome results
None listed