Glucose Variability in Type 1 Diabetes (T1D) and Glycaemic Responses to Food Composition. (NCT06546657) | Clinical Trial Compass
CompletedNot Applicable
Glucose Variability in Type 1 Diabetes (T1D) and Glycaemic Responses to Food Composition.
United Kingdom96 participantsStarted 2021-02-06
Plain-language summary
The study proposed to recruit approximately 435 children and young people who have T1D and who regularly use Dexcom continuous glucose monitoring (CGM). Recruitment was be via their local dietitian. The dietitian was asked to provide baseline information about the participants which will include demographic data and information on clinical data, treatment and anthropometrics. Participants will be asked to provide access to Dexcom CGM data throughout the period of recording. Participants were issued with, for seven consecutive days, two survey questionnaires, one in the morning at breakfast time and the other in the evening. The morning survey will include questions on the breakfast meal (including a photograph of the meal) and insulin dosage, similarly the evening survey will also include questions on diabetes management and food and fluid intake in addition to questions on activities all of which took place during the four-hour postprandial period. These data will be statistically described using univariate, bivariate and multivariate analysis.
Who can participate
Age range
1 Year – 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:
* Children and young people aged between 1-17 years
* Diagnosis of type 1 diabetes for a minimum of one year
* Using multiple daily injections (MDI) together with carbohydrate counting or Continuous Subcutaneous Insulin Infusion (CSII)
* Using Dexcom continuous glucose monitoring (CGM) on a regular basis.
* Access to internet and email
Exclusion Criteria:
* Prescribed anti-hyperglycaemia agents i.e. Glucophage (Metformin) and or antidepressants.
* Have other medical conditions, including complications of diabetes and coeliac disease will be excluded.
* Currently enrolled in another research study
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
Mean Postprandial Glucose
Timeframe: From baseline (start of meal) to 4 hours postprandial at 5min intervals