N/A
Completed N=26
The Breakfast Rise, Education and Knowledge Study
type1diabetes
Source: ClinicalTrials.gov NCT05698875 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Mean Glucose (mmol/l) — 9.5; 8.0; 8.7; 8.4 mmol/l — p=0.12
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Glucose (mmol/l) |
9.5; 8.0; 8.7; 8.4 | 0.12 |
| SECONDARY Mean Glucose Excursion |
2.8; 1.3; 1.9; 2.1 | 0.08 |
| SECONDARY Mean Peak Glucose Excursion |
6.4; 4.2; 4.5; 4.6 | <0.01 sig |
| SECONDARY Mean Time to Peak |
72; 58; 96; 81 | 0.31 |
| SECONDARY Area Under the Glucose Curve |
579; 325; 408; 440 | 0.25 |
| SECONDARY Percentage Coefficient of Variation |
26.4; 23.0; 19.8; 19.7 | <0.01 sig |
| SECONDARY Time in Range |
100; 132; 131; 135 | 0.01 sig |
| SECONDARY Time Above Range |
74; 45; 47; 31 | 0.04 sig |
| SECONDARY Time in Tight Range |
60; 97; 69; 88 | 0.16 |
| SECONDARY Glucose at 30 Minutes |
3.4; 2.2; 1.5; 1.9 | <0.001 sig |
| SECONDARY Glucose at 60 Minutes |
4.9; 2.9; 2.6; 3.0 | <0.001 sig |
| SECONDARY Glucose at 90 Minutes |
4.3; 1.9; 2.9; 3.0 | 0.06 |
| SECONDARY Glucose at 120 Minutes |
3.1; 0.8; 2.5; 2.4 | 0.31 |
| SECONDARY Glucose at 150 Minutes |
1.5; 0.2; 1.7; 1.8 | 0.83 |
| SECONDARY Glucose at 180 Minutes |
0.9; -0.3; 0.9; 0.9 | 0.85 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion 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.
- Vegans
- Allergic or intolerant to the test meals
- Experiencing difficulties with food including diagnosed eating disorders
- Currently actively taking part in another research study
Data sourced from ClinicalTrials.gov (NCT05698875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.