N/A
N=89
Glucose Variability in Type 1 Diabetes (T1D) and Glycaemic Responses to Food Composition.
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT06546657 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Mean Postprandial Glucose — 9.2 mmol/l
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Breakfast (Other)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- University of Stirling
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Postprandial Glucose |
9.2 | — |
| SECONDARY Mean Glucose Excursion |
1.4 | — |
| SECONDARY Peak Glucose Excursion |
4.9 | — |
| SECONDARY Time to Peak |
123.8 | — |
| SECONDARY Area Under the Curve |
500 | — |
| SECONDARY Coefficient of Variation Percentage |
23.3 | — |
| SECONDARY Time in Range (Minutes) |
147 | — |
| SECONDARY CV% and Glycaemic Index (GI) of Breakfast Meal |
22.6; 24.7; 20.4 | 0.14 |
| SECONDARY Mean Postprandial Glucose and Glycaemic Index of Breakfast Meal |
9.4; 9.0; 9.4 | 0.65 |
| SECONDARY Mean Postprandial Glucose and Glycaemic Load of Breakfast Meals |
9.0; 8.9; 9.3 | 0.25 |
| SECONDARY Time to Peak Across Categories of Glycaemic Load |
148; 132; 118 | 0.04 sig |
| SECONDARY Mean Postprandial Glucose and Type of Breakfast Meal |
9.6; 8.5 | 0.01 sig |
| SECONDARY Coefficient of Variation Percentage Over 90 Days |
37.9 | — |
| SECONDARY Diurnal Coefficient of Variation Percentage Over 90 Days |
38.1 | <0.001 sig |
| SECONDARY Nocturnal Coefficient of Variation Percentage Over 90 Days |
36.4 | — |
Summary
The study proposed to recruit approximately 435 children and young people who have T1D and who regularly use Dexcom continuous glucose monitoring (CGM). Recruitment was be via their local dietitian. The dietitian was 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 were issued with, for seven consecutive days, two survey questionnaires, one in the morning at breakfast time and the other in the evening. The morning survey will include questions on the breakfast meal (including a photograph of the meal) and insulin dosage, similarly the evening survey will also include questions on diabetes management and food and fluid intake in addition to questions on activities all of which took place during the four-hour postprandial period. These data will be statistically described using univariate, bivariate and multivariate analysis.
Eligibility Criteria
Inclusion Criteria
- Children and young people aged between 1-17 years
- Diagnosis of type 1 diabetes for a minimum of one year
- Using multiple daily injections (MDI) together with carbohydrate counting or Continuous Subcutaneous Insulin Infusion (CSII)
- Using Dexcom continuous glucose monitoring (CGM) on a regular basis.
- Access to internet and email
Exclusion Criteria
- Prescribed anti-hyperglycaemia agents i.e. Glucophage (Metformin) and or antidepressants.
- Have other medical conditions, including complications of diabetes and coeliac disease will be excluded.
- Currently enrolled in another research study
Data sourced from ClinicalTrials.gov (NCT06546657). 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.