Type 1 DiabetesNCT06546657
Glucose Variability in Type 1 Diabetes (T1D) and Glycaemic Responses to Food Composition.
An observational study of Type 1 Diabetes, run by University of Stirling at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Breakfast
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2021to 20 Nov 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and young people aged 1-17 who have type 1 diabetes
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Faculty of Health Sciences and Sport
Stirling, Stirlingshire, FK9 4LA
About this study
Official title: An Investigation Into Diurnal Variability in Glucose Levels in Paediatric Patients With Type 1 Diabetes (T1D) and Their Responses to Different Food Compositions
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.
Read the detailed description
This is a quantitative observational study. Dexcom CGM data was collected for the period recording. Retrospective CGM data was collected to assess glucose variability during the day and night time periods. The Participants were then asked to provide information for seven days about their breakfast meal and the four hour post meal period. This included information on the type of meal consumed, a photograph of the meal and their diabetes management for the meal for example the insulin dose amount and timing. For the four hour post meal period the participants were asked about any adjustments they had to make to their diabetes management for example the treatment of high or low glucose readings, any snacks they ate and any activities they took part in. They were also asked to describe their mood during the post meal period.
Recruitment - Paediatric diabetes dietitians, working across the United Kingdom (UK), were enrolled to help recruit participants and become principal investigators (PI) for their site.
As this was an observational study there was no power calculation. The sample size was calculated from the number of dietitians that were likely to be available to help with recruitment; this was estimated to be around 32 and was based on the number that had already been approached. It was felt that they would have capacity to recruit 13-14 participants and this would result in 435 participants.
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.
Glucose measurement data on interstitial glucose was be collected via Dexcom CGM. The Dexcom CGM data will be accessed by a research 'Clarity Clinic' with Dexcom CLARITY® Clinic Portal (Dexcom In, San Diego, California (CA), USA). The researcher was the administrator of this clinic. Once the local dietitian had recruited, the participant's parent's email address will be sent to the researcher along with the baseline information/data as described above. The researcher, as administrator of the Clarity Clinic account, then invited the participant, via email, to be added to the clinic. Once the invite has been accepted, it stood for the period of the recording i.e. until all the seven day breakfast recording period was completed. Once the participant had submitted their last questionnaire, they were removed from the Dexcom CLARITY® Clinic Portal.
The participants were not asked to make changes to their diabetes management and their breakfast meal. The participants were asked to submit two daily questionnaires (a morning and post-meal questionnaire) for seven days about their breakfast meal and the postprandial period and email a photograph of the breakfast meal.
The morning questionnaire was about the breakfast meal and included the following questions:
Participant's artificial identifier Date (of when meal was taken) The total average daily insulin dose (both bolus and basal insulin) if known (participant will only be asked to provide this once) Food eaten at breakfast including portion size, type and brand Drinks taken at breakfast including volume, type and brand The total carbohydrate count of breakfast in grams The number of units of insulin taken with breakfast How many units were given for a correction dose The type of bolus (for those on an insulin pump) The time of when the insulin dose was administered The time that breakfast started and ended How the bolus was calculated The amount of breakfast that was consumed (all, ¾, ½, ¼, none)
The post meal questionnaire included the following questions:
Participant's artificial identifier Date (of when meal was taken) Details of any hypo's in the four-hour postprandial period (time, treatment) Details of correction doses given in the four-hour postprandial period (whether in response to Dexcom CGM, times and number of units if insulin) Details of snacks taken in the four-hour postprandial period (type and amount of carbohydrate, responses to Dexcom CGM, number of units of insulin) Details of drinks taken in the four-hour postprandial period (volume, type/brand, carbohydrate amount if applicable) Details of any other adjustments made to insulin and or carbohydrate Type and duration of all physical activities undertaken during the 4-hour post prandial period Details of insulin adjustments made for physical activities Details of any addition information e.g. mood, menstruating, illness, stressors
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.
- Conditions
- Type 1 Diabetes
- Being tested
- Breakfast
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreakfastOther
Breakfast meal
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Postprandial Glucose
Mean CGM reading for 387 breakfast meals over 4 hour postprandial period
Measured: From baseline (start of meal) to 4 hours postprandial at 5min intervals
Secondary outcomes (14)
Mean Glucose Excursion
The excursion is calculated by subtracting the baseline glucose from each 5min CGM reading over 4 hours. For example if at baseline the glucose is 9mmol/l and at 5min postprandial it is 9.3mmol/l the excursion at 5min is 0.3mmol/l. The mean excursion is then calculated over 4 hours for each breakfast meal (381) which had a glucose reading at baseline.
Measured: From baseline (start of meal) to 4 hours postprandial at 5min intervals
Peak Glucose Excursion
The peak glucose excursions calculated from the CGM readings for 381 breakfast meals over 4 hour postprandial period - this is the highest excursion over the 4 hour period
Measured: From baseline (start of meal) to 4 hours postprandial at 5 min intervals
Time to Peak
From CGM data. This is the time of the highest excursion over the 4-hour period
Measured: From baseline (start of meal) to 4 hours postprandial at 5 min intervals
Area Under the Curve
Calculated from the CGM readings for 381 breakfast meals over 4 hour postprandial period
Measured: From baseline (start of meal) to 4 hours postprandial at 5 min intervals
Coefficient of Variation Percentage
Calculated from the CGM reading for 387 breakfast meals over 4 hour postprandial period
Measured: From baseline (start of meal) to 4 hours postprandial
Time in Range (Minutes)
Calculated from the CGM readings for 387 breakfast meals over 4 hour postprandial period. Time in range refers to the time spent with a glucose reading between 3.9-10mmol/l
Measured: From baseline (start of meal) to 4 hours postprandial at 5min intervals
CV% and Glycaemic Index (GI) of Breakfast Meal
The CV% taken from CGM data over a 4hour postprandial period from the ingestion of breakfast meals that had a high and medium glycaemic index
Measured: From baseline (start of meal) to 4 hours postprandial
Mean Postprandial Glucose and Glycaemic Index of Breakfast Meal
Mean postprandial glucose from CGM data after ingestion of breakfast meal by three categories of glycaemic index (low medium and high)
Measured: From baseline (start of meal) to 4 hours postprandial
Mean Postprandial Glucose and Glycaemic Load of Breakfast Meals
Mean postprandial glucose from CGM data after ingestion of breakfast meals across three categories of glycaemic load (low, medium and high)
Measured: From baseline (start of meal) to 4 hours postprandial
Time to Peak Across Categories of Glycaemic Load
CGM data over 4 hour postprandial period for three categories of glycaemic load.
Measured: From baseline (start of meal) to 4 hours postprandial
Mean Postprandial Glucose and Type of Breakfast Meal
Mean postprandial glucose from CGM data over four hours postprandial period after ingestion of breakfast meal containing a ready to eat cereal compared with breakfast meals containing a protein food
Measured: From baseline (start of meal) to 4 hours postprandial
Coefficient of Variation Percentage Over 90 Days
This measures the amount of dispersion (spread) around the mean. It is calculated from the standard deviation divided by the mean and multiplied by 100 to give a percentage. This was taken from the standard deviation and mean from up to 90 days of retrospective CGM data (mean of 79.3 days of CGM readings). This represents how much glucose moves up and down. %CV of 36% or less indicates stable glucose
Measured: 90 days
Diurnal Coefficient of Variation Percentage Over 90 Days
This measures the amount of dispersion (spread) around the mean. It is calculated from the standard deviation divided by the mean and multiplied by 100 to give a percentage. This was taken from the standard deviation and mean from up to 90 days of retrospective CGM data (mean of 79.3 days of CGM readings) for the 06.00-22.00 period of time. This represents how much glucose moves up and down. A CV% of 36% or less indicates stable glucose
Measured: 90 days of CGM data
Nocturnal Coefficient of Variation Percentage Over 90 Days
This measures the amount of dispersion (spread) around the mean. It is calculated from the standard deviation divided by the mean and multiplied by 100 to give a percentage. This was taken from the standard deviation and mean from up to 90 days of retrospective CGM data (mean of 79.3 days of CGM readings) for the 22.00 - 06.00 period of time. This represents how much glucose moves up and down. A CV% of 36% or less indicates stable glucose
Measured: 90 days of CGM data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start6 Feb 2021
- Primary completion20 Nov 2021
- Study completion20 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Johnson, MNutr, Principal investigator, University of Stirling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546657
- Sponsor's protocol ID
- 273640
- Status last verified
- Jan 2025
- First submitted
- 6 Aug 2024
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barnea-Goraly N, Raman M, Mazaika P, Marzelli M, Hershey T, Weinzimer SA, Aye T, Buckingham B, Mauras N, White NH, Fox LA, Tansey M, Beck RW, Ruedy KJ, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). Alterations in white matter structure in young children with type 1 diabetes. Diabetes Care. 2014 Feb;37(2):332-40. doi: 10.2337/dc13-1388. Epub 2013 Dec 6.
PubMed 24319123Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
PubMed 31177185Bell KJ, Smart CE, Steil GM, Brand-Miller JC, King B, Wolpert HA. Impact of fat, protein, and glycemic index on postprandial glucose control in type 1 diabetes: implications for intensive diabetes management in the continuous glucose monitoring era. Diabetes Care. 2015 Jun;38(6):1008-15. doi: 10.2337/dc15-0100.
PubMed 25998293Bluestone JA, Herold K, Eisenbarth G. Genetics, pathogenesis and clinical interventions in type 1 diabetes. Nature. 2010 Apr 29;464(7293):1293-300. doi: 10.1038/nature08933.
PubMed 20432533Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5.
PubMed 28055230Boland E, Monsod T, Delucia M, Brandt CA, Fernando S, Tamborlane WV. Limitations of conventional methods of self-monitoring of blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1858-62. doi: 10.2337/diacare.24.11.1858.
PubMed 11679447Bowering K, Case C, Harvey J, Reeves M, Sampson M, Strzinek R, Bretler DM, Bang RB, Bode BW. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017 Jul;40(7):951-957. doi: 10.2337/dc16-1770. Epub 2017 May 8.
PubMed 28483786Bunn HF, Gabbay KH, Gallop PM. The glycosylation of hemoglobin: relevance to diabetes mellitus. Science. 1978 Apr 7;200(4337):21-7. doi: 10.1126/science.635569.
PubMed 635569Buse JB, Carlson AL, Komatsu M, Mosenzon O, Rose L, Liang B, Buchholtz K, Horio H, Kadowaki T. Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial. Diabetes Obes Metab. 2018 Dec;20(12):2885-2893. doi: 10.1111/dom.13545. Epub 2018 Oct 10.
PubMed 30259644Chugani HT, Phelps ME, Mazziotta JC. Positron emission tomography study of human brain functional development. Ann Neurol. 1987 Oct;22(4):487-97. doi: 10.1002/ana.410220408.
PubMed 3501693Danne T, Phillip M, Buckingham BA, Jarosz-Chobot P, Saboo B, Urakami T, Battelino T, Hanas R, Codner E. ISPAD Clinical Practice Consensus Guidelines 2018: Insulin treatment in children and adolescents with diabetes. Pediatr Diabetes. 2018 Oct;19 Suppl 27:115-135. doi: 10.1111/pedi.12718. No abstract available.
PubMed 29999222Derr R, Garrett E, Stacy GA, Saudek CD. Is HbA(1c) affected by glycemic instability? Diabetes Care. 2003 Oct;26(10):2728-33. doi: 10.2337/diacare.26.10.2728.
PubMed 14514571DiMeglio LA, Acerini CL, Codner E, Craig ME, Hofer SE, Pillay K, Maahs DM. ISPAD Clinical Practice Consensus Guidelines 2018: Glycemic control targets and glucose monitoring for children, adolescents, and young adults with diabetes. Pediatr Diabetes. 2018 Oct;19 Suppl 27:105-114. doi: 10.1111/pedi.12737. No abstract available.
PubMed 30058221Eisenbarth GS. Type I diabetes mellitus. A chronic autoimmune disease. N Engl J Med. 1986 May 22;314(21):1360-8. doi: 10.1056/NEJM198605223142106. No abstract available.
PubMed 3517648Faber EM, van Kampen PM, Clement-de Boers A, Houdijk ECAM, van der Kaay DCM. The influence of food order on postprandial glucose levels in children with type 1 diabetes. Pediatr Diabetes. 2018 Jun;19(4):809-815. doi: 10.1111/pedi.12640. Epub 2018 Mar 12.
PubMed 29527759
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into Diurnal Variability in Glucose Levels in Paediatric Patients With Type 1 Diabetes (T1D) and Their Responses to Different Food Compositions
- ClinicalTrials.gov ID
- NCT06546657
- Acronym / sponsor ID
- 273640
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Study start
- 6 Feb 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Nov 2021 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a quantitative observational study. Dexcom CGM data was collected for the period recording. Retrospective CGM data was collected to assess glucose variability during the day and night time periods. The Participants were then asked to provide information for seven days about their breakfast meal and the four hour post meal period. This included information on the type of meal consumed, a photograph of the meal and their diabetes management for the meal for example the insulin dose amount and timing. For the four hour post meal period the participants were asked about any adjustments they had to make to their diabetes management for example the treatment of high or low glucose readings, any snacks they ate and any activities they took part in. They were also asked to describe their mood during the post meal period.
Recruitment - Paediatric diabetes dietitians, working across the United Kingdom (UK), were enrolled to help recruit participants and become principal investigators (PI) for their site.
As this was an observational study there was no power calculation. The sample size was calculated from the number of dietitians that were likely to be available to help with recruitment; this was estimated to be around 32 and was based on the number that had already been approached. It was felt that they would have capacity to recruit 13-14 participants and this would result in 435 participants.
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.
Glucose measurement data on interstitial glucose was be collected via Dexcom CGM. The Dexcom CGM data will be accessed by a research 'Clarity Clinic' with Dexcom CLARITY® Clinic Portal (Dexcom In, San Diego, California (CA), USA). The researcher was the administrator of this clinic. Once the local dietitian had recruited, the participant's parent's email address will be sent to the researcher along with the baseline information/data as described above. The researcher, as administrator of the Clarity Clinic account, then invited the participant, via email, to be added to the clinic. Once the invite has been accepted, it stood for the period of the recording i.e. until all the seven day breakfast recording period was completed. Once the participant had submitted their last questionnaire, they were removed from the Dexcom CLARITY® Clinic Portal.
The participants were not asked to make changes to their diabetes management and their breakfast meal. The participants were asked to submit two daily questionnaires (a morning and post-meal questionnaire) for seven days about their breakfast meal and the postprandial period and email a photograph of the breakfast meal.
The morning questionnaire was about the breakfast meal and included the following questions:
Participant's artificial identifier Date (of when meal was taken) The total average daily insulin dose (both bolus and basal insulin) if known (participant will only be asked to provide this once) Food eaten at breakfast including portion size, type and brand Drinks taken at breakfast including volume, type and brand The total carbohydrate count of breakfast in grams The number of units of insulin taken with breakfast How many units were given for a correction dose The type of bolus (for those on an insulin pump) The time of when the insulin dose was administered The time that breakfast started and ended How the bolus was calculated The amount of breakfast that was consumed (all, ¾, ½, ¼, none)
The post meal questionnaire included the following questions:
Participant's artificial identifier Date (of when meal was taken) Details of any hypo's in the four-hour postprandial period (time, treatment) Details of correction doses given in the four-hour postprandial period (whether in response to Dexcom CGM, times and number of units if insulin) Details of snacks taken in the four-hour postprandial period (type and amount of carbohydrate, responses to Dexcom CGM, number of units of insulin) Details of drinks taken in the four-hour postprandial period (volume, type/brand, carbohydrate amount if applicable) Details of any other adjustments made to insulin and or carbohydrate Type and duration of all physical activities undertaken during the 4-hour post prandial period Details of insulin adjustments made for physical activities Details of any addition information e.g. mood, menstruating, illness, stressors
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and young people aged 1-17 who have type 1 diabetes
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreakfastBreakfast meal | Other | – |
Primary outcome
Mean Postprandial Glucose
Time frame: From baseline (start of meal) to 4 hours postprandial at 5min intervals
Mean CGM reading for 387 breakfast meals over 4 hour postprandial period
14 secondary outcomes
Mean Glucose Excursion
Time frame: From baseline (start of meal) to 4 hours postprandial at 5min intervals
Peak Glucose Excursion
Time frame: From baseline (start of meal) to 4 hours postprandial at 5 min intervals
Time to Peak
Time frame: From baseline (start of meal) to 4 hours postprandial at 5 min intervals
Area Under the Curve
Time frame: From baseline (start of meal) to 4 hours postprandial at 5 min intervals
Coefficient of Variation Percentage
Time frame: From baseline (start of meal) to 4 hours postprandial
Time in Range (Minutes)
Time frame: From baseline (start of meal) to 4 hours postprandial at 5min intervals
CV% and Glycaemic Index (GI) of Breakfast Meal
Time frame: From baseline (start of meal) to 4 hours postprandial
Mean Postprandial Glucose and Glycaemic Index of Breakfast Meal
Time frame: From baseline (start of meal) to 4 hours postprandial
Mean Postprandial Glucose and Glycaemic Load of Breakfast Meals
Time frame: From baseline (start of meal) to 4 hours postprandial
Time to Peak Across Categories of Glycaemic Load
Time frame: From baseline (start of meal) to 4 hours postprandial
Mean Postprandial Glucose and Type of Breakfast Meal
Time frame: From baseline (start of meal) to 4 hours postprandial
Coefficient of Variation Percentage Over 90 Days
Time frame: 90 days
Diurnal Coefficient of Variation Percentage Over 90 Days
Time frame: 90 days of CGM data
Nocturnal Coefficient of Variation Percentage Over 90 Days
Time frame: 90 days of CGM data
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24319123Barnea-Goraly N, Raman M, Mazaika P, Marzelli M, Hershey T, Weinzimer SA, Aye T, Buckingham B, Mauras N, White NH, Fox LA, Tansey M, Beck RW, Ruedy KJ, Kollman C, Cheng P, Reiss AL; Diabetes Research in Children Network (DirecNet). Alterations in white matter structure in young children with type 1 diabetes. Diabetes Care. 2014 Feb;37(2):332-40. doi: 10.2337/dc13-1388. Epub 2013 Dec 6.
- Results publication: PubMed 31177185Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
- Results publication: PubMed 25998293Bell KJ, Smart CE, Steil GM, Brand-Miller JC, King B, Wolpert HA. Impact of fat, protein, and glycemic index on postprandial glucose control in type 1 diabetes: implications for intensive diabetes management in the continuous glucose monitoring era. Diabetes Care. 2015 Jun;38(6):1008-15. doi: 10.2337/dc15-0100.
- Results publication: PubMed 20432533Bluestone JA, Herold K, Eisenbarth G. Genetics, pathogenesis and clinical interventions in type 1 diabetes. Nature. 2010 Apr 29;464(7293):1293-300. doi: 10.1038/nature08933.
- Results publication: PubMed 28055230Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5.
- Results publication: PubMed 11679447Boland E, Monsod T, Delucia M, Brandt CA, Fernando S, Tamborlane WV. Limitations of conventional methods of self-monitoring of blood glucose: lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1858-62. doi: 10.2337/diacare.24.11.1858.
- Results publication: PubMed 28483786Bowering K, Case C, Harvey J, Reeves M, Sampson M, Strzinek R, Bretler DM, Bang RB, Bode BW. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017 Jul;40(7):951-957. doi: 10.2337/dc16-1770. Epub 2017 May 8.
- Results publication: PubMed 635569Bunn HF, Gabbay KH, Gallop PM. The glycosylation of hemoglobin: relevance to diabetes mellitus. Science. 1978 Apr 7;200(4337):21-7. doi: 10.1126/science.635569.
- Results publication: PubMed 30259644Buse JB, Carlson AL, Komatsu M, Mosenzon O, Rose L, Liang B, Buchholtz K, Horio H, Kadowaki T. Fast-acting insulin aspart versus insulin aspart in the setting of insulin degludec-treated type 1 diabetes: Efficacy and safety from a randomized double-blind trial. Diabetes Obes Metab. 2018 Dec;20(12):2885-2893. doi: 10.1111/dom.13545. Epub 2018 Oct 10.
- Results publication: PubMed 3501693Chugani HT, Phelps ME, Mazziotta JC. Positron emission tomography study of human brain functional development. Ann Neurol. 1987 Oct;22(4):487-97. doi: 10.1002/ana.410220408.
- Results publication: PubMed 29999222Danne T, Phillip M, Buckingham BA, Jarosz-Chobot P, Saboo B, Urakami T, Battelino T, Hanas R, Codner E. ISPAD Clinical Practice Consensus Guidelines 2018: Insulin treatment in children and adolescents with diabetes. Pediatr Diabetes. 2018 Oct;19 Suppl 27:115-135. doi: 10.1111/pedi.12718. No abstract available.
- Results publication: PubMed 14514571Derr R, Garrett E, Stacy GA, Saudek CD. Is HbA(1c) affected by glycemic instability? Diabetes Care. 2003 Oct;26(10):2728-33. doi: 10.2337/diacare.26.10.2728.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Johnson, MNutr principal investigator
University of Stirling
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by University of Stirling at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Postprandial Glucose (time frame: From baseline (start of meal) to 4 hours postprandial at 5min intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06546657, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.