NCT05698875Completed
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
Source: ClinicalTrials.gov · Last updated 11 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 2 Dec 2022
- Start date
- 14 Feb 2023
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University of Stirling
- Diseases
- Type 1 diabetes
- NCT number
- NCT05698875
What you commit to
- Study type: Interventional
- Participants enrolled: 48
- From 14 Feb 2023 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any other medical conditions that may impact on the digestion and or absorption of nutrients, including coeliac disease and gastroparesis.
- Allergic or intolerant to the test meals
- Experiencing difficulties with food including diagnosed eating disorders
Other
- Prescribed anti-hyperglycaemia agents i.e. Glucophage (Metformin) and or antidepressants.
- Vegans
- Currently actively taking part in another research study
Who the study is looking for
- Children and young people aged between 5-17 years
- Diagnosis of type 1 diabetes for a minimum of one year
- On 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 basis
- Have a Dexcom Clarity account and use the Clarity App
- Regularly eats a breakfast meal before midday
- Access to internet and email
Age in the registry: 5 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of Health Sciences and Sport Coordinator of this site? Confirm its status | Stirling | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.