MedTrace Logo

The Breakfast Rise, Education and Knowledge Study

NCT05698875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-03-11

Study results available
· View outcomes & findings →

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.

Conditions

  • type1diabetes

Interventions

OTHER

Breakfast meals

Test meal 1: HGL Test meal 2: HGLP Test meal 3: MGL Control meal: usual breakfast

Sponsors & Collaborators

  • University of Stirling

    lead OTHER

Principal Investigators

  • Julie Johnson, MNutr · University of Stirling

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-14
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05698875 on ClinicalTrials.gov