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Enrolling By Invitation
NCT05698875
The Breakfast Rise, Education and Knowledge Study
Conditions: type1diabetes
Sex: All
Ages: 5 Years – 17 Years
Phase: NA
Enrollment: 90
Sponsor: University of Stirling
Location: United Kingdom
Summary
The study proposes to recruit 90 children and young people who have type 1 diabetes (T1D) and who regularly use Dexcom continuous glucose monitoring (CGM).
The participants will be recruited from National Health Service (NHS) sites in the United Kingdom (UK) via their managing dietitian.
The dietitian will be 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 will be asked to test three breakfast meals (high glycaemic load, high glycaemic with 10g added protein and medium glycaemic load) plus a control meal (usual breakfast), repeating each meal twice in a randomized order using a Latin square randomisation.
The dietitian will be asked to optimise the participants insulin doses prior to commencing test meals.
Participants will be asked to complete a questionnaire for each of the postprandial test and control meal periods.
This will include questions about their diabetes management, food and fluid intake in addition to questions on activities all of which took place during the three-hour postprandial period.
The glycaemic response to the test and control meals will be analysed using the CGM data and the results statistically described using univariate, bivariate and multivariate analysis.
Eligibility Criteria
Inclusion Criteria:Children and young people aged between 5-17 yearsDiagnosis of type 1 diabetes for a minimum of one yearOn multiple daily injections (MDI) together with carbohydrate counting or Continuous Subcutaneous Insulin Infusion (CSII) using either open or closed loop systems.Use Dexcom continuous glucose monitoring (CGM) on a regular basisHave a Dexcom Clarity account and use the Clarity AppRegularly eats a breakfast meal before middayAccess to internet and emailExclusion Criteria:Prescribed anti-hyperglycaemia agents i.e.
Glucophage (Metformin) and or antidepressants.Any other medical conditions that may impact on the digestion and or absorption of nutrients, including coeliac disease and gastroparesis.VegansAllergic or intolerant to the test mealsExperiencing difficulties with food including diagnosed eating disordersCurrently actively taking part in another research study
Source: ClinicalTrials.gov (NCT05698875). StuddyBuddy aggregates publicly available trial information.
