WithdrawnNot Applicable

Slow Digestible Carbohydrates and Exercise in Adolescents With Type 1 Diabetes

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

United States0Started 2023-07-15

Plain-language 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.

Who can participate

Age range12 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of hypoglycemic events 12 hours after completion of exercise challenge

Timeframe: 12 hours after exercise challenge

Glycemic variability during exercise challenge

Timeframe: During exercise challenge

Time to completion of distance bike challenge

Timeframe: During exercise challenge

Trial details

NCT IDNCT05540132

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-15

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