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BREAK: The Breakfast Rise, Education and Knowledge Study

Sponsor
University of Stirling (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05698875
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
30
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: High glycaemic load breakfast meal
  • Other: High glycaemic load breakfast meal with additional 10g protein
  • Other: Medium glycaemic load breakfast meal
 N/A

Detailed Description

This is a quantitative study. Dexcom CGM data will be collected for the period of recording. Participants will be asked to test three breakfast meals on two occasions and submit a postprandial questionnaire after each test meal to confirm it has been tested. The postprandial period will be three hours following the end of the breakfast test meal. The test meal recipes will be provided by the chief investigator. The dietary composition of the meals has been analysed using the a dietary analysis programme. The glycaemic index and load of the meals is estimated from this programme which uses available date from the international tables of glycaemic index and glycaemic loads (Atkinson et al. 2008; 2021). Most foods were based on average composition across different brands. For the added fibre bread used in test meal 3, an average of three known brands was used calculated by the chief investigator. The meals will be taken in the home environment with the food provided by the families. The participants will be asked to take the test meal on a day when their CGM reading is between 4-10mmol/l and when there has been no nocturnal hypoglycaemia on the night before the planned test. The participants will act as their own control. They will be asked to complete a postprandial questionnaire for control meals as well. The control meals will be there usual breakfast of choice. The study duration, commencing with the recruitment of the first participant and ending when data has been fully described, is anticipated to be two years.

Recruitment Paediatric diabetes dietitians, working across the UK, will be enrolled to help recruit participants and become principal investigators (PI) for their site.

Sample size The sample size power calculation is 64. This is based on using ANOVA repeated measures, within factors with four groups and measurements (3 test meals and control) with small effect size (0.15), P value 0.05 and power 0.80 and correlation among repeated measure of 0.5. The drop rate of clinical trials is often over 40%. Therefore, the aim is to recruit 90 participants to allow for this dropout rate and meet the sample size of 64. It may be possible to recruit this number of participants. There are approximately 29,000 children and young people living in the UK with T1D (Juvenile Diabetes Research Federation (JDRF), 2018). In the first phase of this study, 12 NHS sites were enrolled, and 96 children and young people were recruited to the study.

Methodology Baseline data

In order to make comparisons between relevant variables and glucose levels, the following baseline data will be collected from the dietitians and sent to the chief investigator, along with the artificial identifier on the Excel spreadsheet as discussed earlier at the stage of recruitment of participants:

  • Parent's email address

  • Sex, date of birth and recent weight and height (for calculation of BMI and BMI centile) and date of when this was taken

  • Date of diagnosis of T1D

  • Last four HbA1c

  • Total daily insulin dose (TDD)

  • Insulin: carbohydrate ratios (ICR) and Insulin Sensitivity Factor (ISF)

  • Current insulin regimen - including the type of insulin prescribed and if applicable type of insulin pump i.e. open or closed loop system.

Run-in period At recruitment the dietitians will be asked to arrange a review of the participants insulin regimen including the insulin to carbohydrate ratio's (ICR), insulin sensitivity factor (ISF) and basal background insulin doses/rates. The dietitian will be asked to inform the chief investigator when this has taken place. Participants will be asked to commence the test meals following this.

Glucose measurement Data on interstitial glucose will be collected via Dexcom CGM. The Dexcom CGM data will be accessed by an NHS Highland research 'Clarity Clinic' with Dexcom CLARITY® Clinic Portal (Dexcom In, San Diego, California (CA), USA). The chief investigator is administrator of this clinic. Once the managing dietitian has obtained each participant's consent, the participant's parent's email address will be sent to the chief investigator along with the baseline information/data as described above. The chief investigator, as administrator of the Clarity Clinic account, will then invite the participant, via email, to be added to the clinic. Once the invite has been accepted, it will stand for the period of the recording i.e. until all the test meals and questionnaires have been completed. Once the participant has submitted their last questionnaire, they will be removed from the Dexcom CLARITY® Clinic Portal.

Following the provision of CGM data and review of the insulin regimen by the diabetes team, participants will be randomised to test each of the three test meals on two separate occasions with a control meal (usual breakfast meal) for each test meal. Randomisation will be 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.

The test meals are based on foods children and young people enjoy eating. There are three meals. Test meal one includes a high glycaemic index cereal meal with milk and has a high glycaemic load (> 20), test meal two is the same cereal meal with a high glycaemic load (>20) with addition of 10g protein and test meal three has a medium glycaemic load (10-20). For test meals one and two there are three portion size options to meet age appropriate requirements and appetites. The participants will be able to choose from two different cereals for test meal 1 and a choice of protein sources for test meal 2. They will be asked to keep to the same choice of cereal and protein source for the repeat meal. They will be asked to consume at least 75% of the meal to ensure the threshold of the glycaemic load is met. The instructions and details of the test meals are presented in Appendix 11. The control meals will be the participant's usual breakfast of choice.

Participants will be asked to follow their usual insulin regimen as advised by their diabetes team i.e. their usual insulin dose and dose timing. For both test and control meals participants will be asked to avoid any further food intake during three-hour postprandial period other than carbohydrate adjustments required to treat any hypoglycaemia. Participants will also be asked to avoid drinks except water or carbohydrate free juices. They will also be asked to avoid physical activity of more than 30 minutes in duration. To minimise disruption to their normal daily activities, they will be advised to test the meal on a day when there is no planned physical activity i.e. a school day with no morning physical education. The CGM data will be collected throughout this time as discussed above.

Postprandial Questionnaire The participants will be asked to complete a postprandial questionnaire using 'online survey'. This includes questions about the meal and the three-hour postprandial period. The questionnaire is presented in Appendix 10. They will be asked to wait a minimum of three hours before answering and submitting the questionnaire. They will be encouraged to complete it on the same day as the test or control meal.

Data analysis This will be a mix of univariate, bivariate and multivariate analysis as this is best suited to describing, summarising and visualising these data. Outputs will include the distribution of glucose levels post-breakfast to determine the spread and dispersion of the data.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will be randomised to test each of the three test meals on two separate occasions with a control meal (usual breakfast meal) for each test meal. Randomisation will be 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.Participants will be randomised to test each of the three test meals on two separate occasions with a control meal (usual breakfast meal) for each test meal. Randomisation will be 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.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Breakfast Rise, Education and Knowledge Study in Children and Young People Who Have Type 1 Diabetes (T1D): The BREAK Study
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Test meal 1

High glycaemic load breakfast meal

Other: High glycaemic load breakfast meal
Breakfast meal
Other: Test meal 2

High glycaemic lead with additional 10g protein breakfast meal

Other: High glycaemic load breakfast meal with additional 10g protein
Breakfast meal
Other: Test meal 3

Medium glycaemic load breakfast meal

Other: Medium glycaemic load breakfast meal
Breakfast meal

Outcome Measures

Primary Outcome Measures

  1. Mean glucose (mmol/l) [three-hour postprandial breakfast period]

    mmol/l

Secondary Outcome Measures

  1. Mean peak glucose [three-hour postprandial breakfast period]

    mmol/l

  2. Mean time to peak [three-hour postprandial breakfast period]

    minutes

  3. Mean time to recover [three-hour postprandial breakfast period]

    minutes

  4. Area under the glucose curve [three-hour postprandial breakfast period]

    mmol/minute

  5. Range times (Time in range, time above range, time below range) [three-hour postprandial breakfast period]

    Percentage

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Health Sciences and Sport Stirling Stirlingshire United Kingdom FK9 4LA

Sponsors and Collaborators

  • University of Stirling

Investigators

  • Principal Investigator: Julie Johnson, MNutr, University of Stirling

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Stirling
ClinicalTrials.gov Identifier:
NCT05698875
Other Study ID Numbers:
  • 316676
First Posted:
Jan 26, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Jan 31, 2023