The Breakfast Rise, Education and Knowledge Study

NCT05698875 | Completed Results

• 1 other identifier: 316676
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean Glucose (mmol/l)

  This is the mean glucose over the 3 hour postprandial period taken from CGM readings taken every 5 minutes

  three-hour postprandial breakfast period

Secondary Outcomes (14)

• Mean Glucose Excursion

  three-hour postprandial breakfast period

• Mean Peak Glucose Excursion

  three-hour postprandial breakfast period

• Mean Time to Peak

  three-hour postprandial breakfast period

• Area Under the Glucose Curve

  three-hour postprandial breakfast period

• Percentage Coefficient of Variation

  3 hours

Study Arms (1)

Breakfast meals

OTHER

All the study participants received in an individual randomised order test breakfast meals: Test Meal 1 high glycaemic load (HGL), Test Meal 2 high glycaemic load with 10g protein (HGLP), Test Meal 3 medium glycaemic load (MGL) and control meal (usual breakfast). There was no wash out period

Other: Breakfast meals

Interventions

Breakfast meals OTHER

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

Breakfast meals

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Stirling: lead

Study Sites (1)

Faculty of Health Sciences and Sport

Stirling, Stirlingshire, FK9 4LA, United Kingdom

Location

Related Publications (45)

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MeSH Terms

Interventions

Breakfast

Intervention Hierarchy (Ancestors)

Meals; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Julie Johnson
• Organization: University of Stirling

julie.johnson1@stir.ac.uk

07815893076

Study Officials

• Julie Johnson, MNutr

  University of Stirling

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be asked to test each of the three test meals and control meal (usual breakfast) on two occasions. The meals will be consumed in an individual randomised order with the randomisation achieved using a Latin square randomisation. The tool used for this will be http://www.jerrydallal.com/random/randomize.htm. Randomisation will be done in a block of four.

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: January 26, 2023
• Study Start: February 14, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 11, 2025
• Results First Posted: March 11, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)