Trial Outcomes & Findings for Glucose Variability in Type 1 Diabetes (T1D) and Glycaemic Responses to Food Composition. (NCT NCT06546657)

NCT ID: NCT06546657

Last Updated: 2025-03-19

Results Overview

Mean CGM reading for 387 breakfast meals over 4 hour postprandial period

• Recruitment status: COMPLETED
• Target enrollment: 96 participants
• Primary outcome timeframe: From baseline (start of meal) to 4 hours postprandial at 5min intervals
• Results posted on: 2025-03-19

Participant Flow

Participants were enrolled from February - November 2021 via their local diabetes centres

96 participants were enrolled 7 participants did not respond or dropped out of the study before sharing CGM data. 89 participants shared their CGM data for glucose variability analysis and of these 74 submitted the breakfast and postprandial questionnaires of which 71 completed with corresponding CGM data.

Participant milestones

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Glucose Variability (CGM Data) STARTED	89
Glucose Variability (CGM Data) Glucose Variability	89
Glucose Variability (CGM Data) COMPLETED	89
Glucose Variability (CGM Data) NOT COMPLETED	0
Breakfast and Postprandial Questionnaire STARTED	74
Breakfast and Postprandial Questionnaire COMPLETED	71
Breakfast and Postprandial Questionnaire NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Glucose Variability and Postprandial Glucose n=89 Participants Collection of CGM data to assess glucose variability
Age, Continuous	10.1 years STANDARD_DEVIATION 3.8 • n=89 Participants
Sex: Female, Male Female	40 Participants n=89 Participants
Sex: Female, Male Male	49 Participants n=89 Participants
Region of Enrollment United Kingdom	89 participants n=89 Participants
HbA1c	57.7 mmol/mol STANDARD_DEVIATION 9.3 • n=89 Participants
Disease duration	4.0 years n=89 Participants
Insulin regimen MDI user	22 Participants n=89 Participants
Insulin regimen CSII user	66 Participants n=89 Participants
Insulin regimen Unknown	1 Participants n=89 Participants

PRIMARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial at 5min intervals

Population: CGM data over 4-hour postprandial period for 387 breakfast meals consumed by 71 participants

Mean CGM reading for 387 breakfast meals over 4 hour postprandial period

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=387 Breakfast meals Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Mean Postprandial Glucose	9.2 mmol/l Standard Deviation 2.7

SECONDARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial at 5min intervals

Population: CGM data over 4-hour postprandial period for 381 breakfast meals consumed by 71 participants

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.

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=381 Breakfast meals with glucose at baseline Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Mean Glucose Excursion	1.4 mmol/l Standard Deviation 2.6

SECONDARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial at 5 min intervals

Population: CGM data over 4-hour postprandial period for 381 breakfast meals consumed by 71 participants

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

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=381 Breakfast meals with glucose at baseline Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Peak Glucose Excursion	4.9 mmol/l Standard Deviation 3.1

SECONDARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial at 5 min intervals

Population: CGM data over 4-hour postprandial period for 381 breakfast meals consumed by 71 participants

From CGM data. This is the time of the highest excursion over the 4-hour period

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=381 Breakfast meals with glucose at baseline Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Time to Peak	123.8 Minutes Standard Deviation 78.1

SECONDARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial at 5 min intervals

Population: CGM data over 4-hour postprandial period for 381 breakfast meals consumed by 71 participants

Calculated from the CGM readings for 381 breakfast meals over 4 hour postprandial period

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=381 Breakfast meals with glucose at baseline Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Area Under the Curve	500 (mmol/l)*min Standard Deviation 439

SECONDARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial

Population: CGM data over 4-hour postprandial period for 387 breakfast meals consumed by 71 participants

Calculated from the CGM reading for 387 breakfast meals over 4 hour postprandial period

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=387 Breakfast meals Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Coefficient of Variation Percentage	23.3 percentage Standard Deviation 9.9

SECONDARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial at 5min intervals

Population: CGM data over 4-hour postprandial period for 387 breakfast meals consumed by 71 participants

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

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=387 Breakfast meals Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Time in Range (Minutes)	147 Minutes Standard Deviation 78.2

SECONDARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial

Population: A comparison of breakfast meals which had a low, medium and high glycaemic index

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

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=386 Breakfast meals with known GI Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
CV% and Glycaemic Index (GI) of Breakfast Meal Low GI breakfast meal	22.6 percentage Standard Deviation 10.5
CV% and Glycaemic Index (GI) of Breakfast Meal Medium GI breakfast meal	24.7 percentage Standard Deviation 9.9
CV% and Glycaemic Index (GI) of Breakfast Meal High GI breakfast meal	20.4 percentage Standard Deviation 7.8

SECONDARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial

Population: A comparison of breakfast meals which had a low, medium and high glycaemic index

Mean postprandial glucose from CGM data after ingestion of breakfast meal by three categories of glycaemic index (low medium and high)

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=386 Breakfast meals Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Mean Postprandial Glucose and Glycaemic Index of Breakfast Meal Low GI breakfast meals	9.4 mmol/l Standard Deviation 2.9
Mean Postprandial Glucose and Glycaemic Index of Breakfast Meal Medium GI breakfast meals	9.0 mmol/l Standard Deviation 2.7
Mean Postprandial Glucose and Glycaemic Index of Breakfast Meal High GI breakfast meals	9.4 mmol/l Standard Deviation 2.5

SECONDARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial

Population: A comparison of breakfast meals which had a low, medium and high glycaemic load

Mean postprandial glucose from CGM data after ingestion of breakfast meals across three categories of glycaemic load (low, medium and high)

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=386 Breakfast meals Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Mean Postprandial Glucose and Glycaemic Load of Breakfast Meals Low glycaemic load meals	9.0 mmol/l Standard Deviation 2.3
Mean Postprandial Glucose and Glycaemic Load of Breakfast Meals Medium glycaemic load meals	8.9 mmol/l Standard Deviation 2.4
Mean Postprandial Glucose and Glycaemic Load of Breakfast Meals High glycaemic load meals	9.3 mmol/l Standard Deviation 2.9

SECONDARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial

Population: A comparison of breakfast meals which had a baseline glucose for low medium and high glycaemic load

CGM data over 4 hour postprandial period for three categories of glycaemic load.

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=380 Breakfast meals with a baseline glucose Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Time to Peak Across Categories of Glycaemic Load Low glycaemic load meals	148 Minutes Standard Deviation 87
Time to Peak Across Categories of Glycaemic Load Medium glycaemic load meals	132 Minutes Standard Deviation 79
Time to Peak Across Categories of Glycaemic Load High glycaemic load meals	118 Minutes Standard Deviation 76

SECONDARY outcome

Timeframe: From baseline (start of meal) to 4 hours postprandial

Population: The is was a sub group analysis of 'Breakfast cereal only' meals vs 'breakfast meals with added protein food'

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

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=147 Breakfast meals Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Mean Postprandial Glucose and Type of Breakfast Meal Breakfast cereal meals	9.6 mmol/l Standard Deviation 2.7
Mean Postprandial Glucose and Type of Breakfast Meal Added protein meals	8.5 mmol/l Standard Deviation 2.0

SECONDARY outcome

Timeframe: 90 days

Population: %CV calculated from a mean of 79.3 days of CGM data

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

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=89 Participants Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Coefficient of Variation Percentage Over 90 Days	37.9 percentage Standard Deviation 4.2

SECONDARY outcome

Timeframe: 90 days of CGM data

Population: Diurnal CV% (06.00-22.00) calculated from 79.3 days of CGM data

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

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=89 Participants Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Diurnal Coefficient of Variation Percentage Over 90 Days	38.1 percentage Standard Deviation 4.3

SECONDARY outcome

Timeframe: 90 days of CGM data

Population: Nocturnal CV% (22.00-06.00) calculated from 79.3 days of CGM data

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

Outcome measures

Measure	Glucose Variability Then Breakfast and Postprandial Questionnaires n=89 Participants Collection of CGM data to assess glucose variability and glucose levels before and during the 4 hours postprandial period after breakfast meal
Nocturnal Coefficient of Variation Percentage Over 90 Days	36.4 percentage Standard Deviation 5.2

Adverse Events

Glucose Variability Then Breakfast and Postprandial Questionnaires

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Julie Johnson

University of Stirling

Phone: 07815893076

Email: julie.johnson1@stir.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place