Slow Digestible Carbohydrates and Exercise in Adolescents With Type 1 Diabetes (NCT05540132) | Clinical Trial Compass
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 range
12 Years – 17 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of hypoglycemic events 12 hours after completion of exercise challenge