NCT05698875

The Breakfast Rise, Education and Knowledge Study

The Breakfast Rise, Education and Knowledge Study in Children and Young People Who Have Type 1 Diabetes (T1D): The BREAK Study
University of Stirling·ClinicalTrials.gov·otherEnrolling by invitation
View on ClinicalTrials.gov
Study focus
Disease/Condition
type1diabetes
Drug/Device/Intervention
High glycaemic load breakfast meal
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
University of Stirling
Location
Stirling, United Kingdom
Timeline & enrollment
Phase
N/A
Start date
Feb 14, 2023
End date
Aug 01, 2025
Enrollment
90 participants
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
Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05698875
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05698875 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Stirling and is currently Enrolling by invitation. The study focuses on type1diabetes. Target enrollment is 90 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.