The Breakfast Rise, Education and Knowledge Study - Trial NCT05698875

Timeline & Enrollment

Primary Outcome

Mean glucose (mmol/l)

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.

ICD-10 Classifications