The Breakfast Rise, Education and Knowledge Study
Condition: type1diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

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.
    

Intervention name(s): High glycaemic load breakfast meal; High glycaemic load breakfast meal with additional 10g protein; Medium glycaemic load breakfast meal
Intervention type(s): Other; Other; Other
Intervention description(s): Breakfast meal; Breakfast meal; Breakfast meal
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.
Masking: None (Open Label)
Primary purpose: Basic Science