The BREAK study
Research type
Research Study
Full title
The Breakfast Rise, Education and Knowledge study in children and young people who have Type 1 Diabetes (T1D): The BREAK study.
IRAS ID
316676
Contact name
Julie Johnson
Contact email
Sponsor organisation
University of Stirling
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 10 months, 31 days
Research summary
Summary of Research
Type 1 diabetes (T1D) is caused by a lack of insulin production, whose main role is to regulate blood glucose levels. Treatment involves administration of insulin with the aim to achieve glucose levels close to normal range, however many children and young people with T1D find their glucose levels often fluctuate well above and below this. High levels in the daytime is mainly caused by food intake and appears worse after breakfast. As blood glucose levels are often only checked before meals, rather than after, there is limited evidence of how often fluctuations occur, and there
is little evidence of how high levels after breakfast may be better managed through diet.
It is now possible to obtain more detailed information about glucose levels by using continuous glucose monitoring (CGM) systems which are now a standard component of diabetes care. This study proposes recruiting children/young people who have T1D and use CGM. Participants will be asked to provide CGM data. The participants will be asked, to test three different breakfast meals repeated on two occasions followed by submission of a questionnaire three hours after breakfast. Participants will act as their own controls and for this will be asked to submit the same questionnaire three hours after breakfast on non-test meal days (control meals) on two occasions. These data will be statistically described and analyzed it establish the extent of glucose variability and postprandial hyperglycaemia after breakfast with results compared between participants and test meal composition.Summary of Results
We wish to thank the children and young people (CYP) and their families for taking part in the study.
General information about the study
The study title:
The Breakfast Rise, Education and Knowledge Study in Children and Young People who have Type 1 Diabetes (T1D): The BREAK study.
Who carried out the research:
The research was carried out by the University of Stirling as part of a clinical doctorate which was funded by the University of Stirling and NHS Highland. The sponsor was the University of Stirling. We planned to recruit children and young people who had type 1 diabetes (T1D) to the study.Where and when the study took place
We received ethical approval for the study in November 2022. We recruited participants from February to November 2023. The study closed on 31/12/2023.Why the research was needed
The researcher had worked with CYPs with T1D as a dietitian for many years. It was noted that CYPs with T1D often experience high glucose levels after breakfast. There appeared to be limited evidence about how best to manage this. We had collected data in the first phase of our study in 2021 which suggested breakfast cereals may cause high glucose levels but adding in some protein to the meal might make high levels less likely to happen.The main research questions
The aim of this study was to investigate the response of sugar levels in CYPs who have T1D following the ingestion of meals at breakfast time which differed in glycaemic index, glycaemic load and protein content.
• The glycaemic index is a measure of how quickly or slowly carbohydrate foods raise the level of sugar (glucose) in the blood; it is based on a scale of 0-100. The higher the food is ranked on the scale the faster the glucose levels are expected to rise in the blood. Pure glucose scores 100 and all other foods are compared to this. Carbohydrate foods are then classified as either low GI (55 or less) moderate GI (56 to 69) and high GI (more than 70).
• Glycaemic load is a calculation based on the glycaemic index of the food and the amount of carbohydrate in the food. The GL has three categories of low, medium and high.Who participated in the study?
• 48 CYPs with T1D were recruited to the study.
Characteristics of the participants
• 43.8% were female, average age was 11.7 years, average years of having T1D was 3.1 years.
• 91.7% of the participants used insulin pumps to manage their diabetes; the remaining 8.3% used multiple daily injections (MDI).
• 56.8% met the target for HbA1c (gold standard measure of diabetes control)
What happened during the study?
• The study was a randomized crossover intervention
• The participants were invited to share their Dexcom CGM data (this records glucose levels in the tissue fluid every 5mins)
• The participants were asked to test three meals twice and tell us about their usual breakfast on two occasions
• 35 participants shared their Dexcom CGM data; 25 of these tested the meals.
• The meals were:
o Test meal 1 (HGL) – this contained a popular breakfast cereal that had a high GI and had a high glycaemic load
o Test meal 2 (HGLP)– the same as test meal 1 with the addition of 10g protein
o Test meal 3 (MGL)– a non-breakfast cereal-based meal of low GI/medium glycemic load meal (enriched fibre bread, chocolate nut spread, berries & natural yoghurt)
o The control meal – this was the participants usual breakfast
• We collected data on 163 meals; 14 meals were excluded; 149 were included in the analysisThe results of the study
Key findings
• The average glucose reading over 3hr was significantly higher after ingestion of the HGL meal compared with the HGLP meals. There was no difference between the HGL and MGL meals nor between the HGLP and MGL meals.
• We looked how high the glucose rose to (peak excursion) during the 3hrs and found that this was significantly higher following the ingestion of the HGL meals
• We looked at the time that was spent in range during the 3hrs and found this to be significantly lower following the ingestion of the HGL meals
• We then looked the time spent in tight range (normal levels of glucose) and this was significantly higher following the ingestion of the HGLP meal
• We looked at each 30min time interval during the 3hrs period to see what the glucose readings were like for each meal. We found that at 30 and 60min the glucose reading following the ingestion of the HGL meal was significantly higher than for all other meals. This remained significantly higher at 90 and 120min compared with HGLP meals. At 120min the glucose reading was significantly higher after the MGL meal compared with the HGLP meal.
• 70.5% of meals were managed with pumps that use hybrid closed loop technology – these can make automatic adjustments to the insulin delivery based on the CGM reading and are known to improve glucose levels - when only these meals were analysed the findings were similar.
How has the study helped?
The study has helped learning about glucose response to some different breakfast meals in CYPs with T1D. The results have shown that:
• A high glycaemic load meal containing a high GI breakfast cereal is likely to cause higher glucose levels after breakfast in CYPs with T1D. This was also observed for those using hybrid closed loop pumps
• Diabetes dietetic education needs to include information on the glycaemic index and glycaemic load
• The addition of 10g of protein to a high GI breakfast cereal meal can reduce the glucose levels after breakfast. This can result in time spent in tighter range than a low GI breakfast meal.
Recommendation for future research
Further research is required to see if the above findings can be replicated and to investigate what happens to glucose levels when other foods are added to a breakfast cereal meal e.g. yoghurt, fruit, breads, pastries. Further research is also required to compare response to breakfast cereals of low and moderate GI.
Contact details for further information: Chief Investigator: Julie Johnson, Registered dietitian & Clinical Doctorate Student, University of Stirling, julie.johnson1@stir.ac.ukREC name
North of Scotland Research Ethics Committee 1
REC reference
22/NS/0123
Date of REC Opinion
3 Oct 2022
REC opinion
Favourable Opinion