Trial Outcomes & Findings for The Breakfast Rise, Education and Knowledge Study (NCT NCT05698875)

NCT ID: NCT05698875

Last Updated: 2025-03-11

Results Overview

This is the mean glucose over the 3 hour postprandial period taken from CGM readings taken every 5 minutes

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 48 participants
• Primary outcome timeframe: three-hour postprandial breakfast period
• Results posted on: 2025-03-11

Participant Flow

Participants diabetes management was optimised at the time of recruitment to ensure that the insulin doses for the breakfast meal were accurate

Following recruitment participants were allocated to a randomised sequence for testing the meals. Randomisation was in a block of four. Of the participants who tested the meals this resulted in 18 different sequences of meal order.

Participant milestones

Measure	Breakfast Meals Test and control meals - Participants were asked to repeat the meals in the allocated randomized order before moving to the next meal e.g. control meal x 2, TM1 x 2 TM3 x 2 and TM2 x 2.
Overall Study STARTED	26
Overall Study Test Meal 1 (HGL)	24
Overall Study Test Meal 2 (HGLP)	20
Overall Study Test Meal 3 (MGL)	20
Overall Study Control Meals	20
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Breakfast Meals n=25 Participants Test and control meals
Age, Continuous	12.1 Years STANDARD_DEVIATION 3.6 • n=25 Participants
Sex: Female, Male Female	10 Participants n=25 Participants
Sex: Female, Male Male	15 Participants n=25 Participants
Region of Enrollment United Kingdom	25 participants n=25 Participants
HbA1c	48.4 mmol/mol STANDARD_DEVIATION 5.4 • n=25 Participants
Disease duration	4.3 Years STANDARD_DEVIATION 3.2 • n=25 Participants
Insulin regimen Multiple Daily Injections (MDI) user	2 Participants n=25 Participants
Insulin regimen Continuous Subcutaneous Insulin Infusion (CSII) user	23 Participants n=25 Participants
Type of insulin pump (CSII) Insulin pump open loop	6 Participants n=25 Participants
Type of insulin pump (CSII) Insulin pump closed	17 Participants n=25 Participants
Type of insulin pump (CSII) NA	2 Participants n=25 Participants

PRIMARY outcome

Timeframe: three-hour postprandial breakfast period

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

This is the mean glucose over the 3 hour postprandial period taken from CGM readings taken every 5 minutes

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Mean Glucose (mmol/l) Test meal 1 (HGL)	9.5 mmol/l Standard Deviation 2.5
Mean Glucose (mmol/l) Test meal 2 (HGLP)	8.0 mmol/l Standard Deviation 2.2
Mean Glucose (mmol/l) Test meal 3 (MGL)	8.7 mmol/l Standard Deviation 2.2
Mean Glucose (mmol/l) Control meal (usual breakfast)	8.4 mmol/l Standard Deviation 2.6

SECONDARY outcome

Timeframe: three-hour postprandial breakfast period

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

This is the mean excursion over the 3 hour postprandial period taken from CGM readings taken every 5 minutes

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Mean Glucose Excursion Test meal 1 (HGL)	2.8 mmol/l Standard Deviation 2.5
Mean Glucose Excursion Test meal 2 (HGLP)	1.3 mmol/l Standard Deviation 1.8
Mean Glucose Excursion Test meal 3 (MGL)	1.9 mmol/l Standard Deviation 2.3
Mean Glucose Excursion Control meal (usual breakfast)	2.1 mmol/l Standard Deviation 2.4

SECONDARY outcome

Timeframe: three-hour postprandial breakfast period

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

This is the peak excursion over the 3 hour postprandial period taken from CGM readings taken every 5 minutes

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Mean Peak Glucose Excursion Test meal 1 (HGL)	6.4 mmol/l Standard Deviation 2.8
Mean Peak Glucose Excursion Test meal 2 (HGLP)	4.2 mmol/l Standard Deviation 2.2
Mean Peak Glucose Excursion Test meal 3 (MGL)	4.5 mmol/l Standard Deviation 2.6
Mean Peak Glucose Excursion Control meal (usual breakfast)	4.6 mmol/l Standard Deviation 2.9

SECONDARY outcome

Timeframe: three-hour postprandial breakfast period

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

This is the time it took the glucose to peak (reach it's highest excursion from baseline) over the 3 hour postprandial period taken from CGM readings taken every 5 minutes

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Mean Time to Peak Test meal 1 (HGL)	72 Minutes Standard Deviation 31
Mean Time to Peak Test meal 2 (HGLP)	58 Minutes Standard Deviation 35
Mean Time to Peak Test meal 3 (MGL)	96 Minutes Standard Deviation 46
Mean Time to Peak Control meal (usual breakfast)	81 Minutes Standard Deviation 45

SECONDARY outcome

Timeframe: three-hour postprandial breakfast period

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

This is incremental area under the glucose curve above baseline over the 3 hour postprandial period taken from CGM readings taken every 5 minutes

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Area Under the Glucose Curve Test meal 1 (HGL)	579 (mmol/l)*min Standard Deviation 396
Area Under the Glucose Curve Test meal 2 (HGLP)	325 (mmol/l)*min Standard Deviation 242
Area Under the Glucose Curve Test meal 3 (MGL)	408 (mmol/l)*min Standard Deviation 348
Area Under the Glucose Curve Control meal (usual breakfast)	440 (mmol/l)*min Standard Deviation 379

SECONDARY outcome

Timeframe: 3 hours

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

This is used to assess glucose variability over the three hour postprandial period taken from CGM readings taken every 5 mins

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Percentage Coefficient of Variation Test meal 1 (HGL)	26.4 percentage Standard Deviation 9.5
Percentage Coefficient of Variation Test meal 2 (HGLP)	23.0 percentage Standard Deviation 8.0
Percentage Coefficient of Variation Test meal 3 (MGL)	19.8 percentage Standard Deviation 6.4
Percentage Coefficient of Variation Control meal (usual breakfast)	19.7 percentage Standard Deviation 8.9

SECONDARY outcome

Timeframe: three-hour postprandial breakfast period

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

This is the time in minutes that was spent with a glucose in range (3.9-10mmol/l over the 3 hours postprandial period

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Time in Range Test meal 2 (HGLP)	132 Minutes Standard Deviation 53
Time in Range Test meal 3 (MGL)	131 Minutes Standard Deviation 49
Time in Range Control meal (usual breakfast)	135 Minutes Standard Deviation 50
Time in Range Test meal 1 (HGL)	100 Minutes Standard Deviation 56

SECONDARY outcome

Timeframe: 3 hours

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

This is the time that the glucose was above range (>10mmol/l) during the 3 hours postprandial period taken from CGM readings taken every 5 minutes

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Time Above Range Test meal 1 (HGL)	74 Minutes Standard Deviation 57
Time Above Range Test meal 2 (HGLP)	45 Minutes Standard Deviation 54
Time Above Range Test meal 3 (MGL)	47 Minutes Standard Deviation 50
Time Above Range Control meal (usual breakfast)	31 Minutes Standard Deviation 34

SECONDARY outcome

Timeframe: 3 hours

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

This the time of glucose reading spent in tight range (3.9-7.8mmol/l) over the three hour postprandial period from CGM readings taken every 5 minutes

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Time in Tight Range Test meal 1 (HGL)	60 Minutes Standard Deviation 46
Time in Tight Range Test meal 2 (HGLP)	97 Minutes Standard Deviation 54
Time in Tight Range Test meal 3 (MGL)	69 Minutes Standard Deviation 49
Time in Tight Range Control meal (usual breakfast)	88 Minutes Standard Deviation 58

SECONDARY outcome

Timeframe: 30 minutes

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

Postprandial glucose excursion taken from CGM readings at 30 minutes after the meal commenced

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Glucose at 30 Minutes Test meal 1 (HGL meal)	3.4 mmol/l Standard Deviation 2.2
Glucose at 30 Minutes Test meal 2 (HGLP meal)	2.2 mmol/l Standard Deviation 2.1
Glucose at 30 Minutes Test meal 3 (MGL meal)	1.5 mmol/l Standard Deviation 2.2
Glucose at 30 Minutes Control meal	1.9 mmol/l Standard Deviation 2.2

SECONDARY outcome

Timeframe: 60 minutes

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

Postprandial glucose excursion taken from CGM readings at 60 minutes after the meal commenced

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Glucose at 60 Minutes Test meal 1 (HGL meal)	4.9 mmol/l Standard Deviation 3.0
Glucose at 60 Minutes Test meal 2 (HGLP meal)	2.9 mmol/l Standard Deviation 2.6
Glucose at 60 Minutes Test meal 3 (MGL meal)	2.6 mmol/l Standard Deviation 3.0
Glucose at 60 Minutes Control meal	3.0 mmol/l Standard Deviation 2.9

SECONDARY outcome

Timeframe: 90 minutes

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

Postprandial glucose excursion taken from CGM readings at 90 minutes after the meal commenced

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Glucose at 90 Minutes Test meal 1 (HGL meal)	4.3 mmol/l Standard Deviation 3.6
Glucose at 90 Minutes Test meal 2 (HGLP meal)	1.9 mmol/l Standard Deviation 2.7
Glucose at 90 Minutes Test meal 3 (MGL meal)	2.9 mmol/l Standard Deviation 3.0
Glucose at 90 Minutes Control meal	3.0 mmol/l Standard Deviation 3.2

SECONDARY outcome

Timeframe: 120 minutes

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

Postprandial glucose excursion taken from CGM readings at 120 minutes after the meal commenced

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Glucose at 120 Minutes Test meal 1 (HGL meal)	3.1 mmol/l Standard Deviation 4.0
Glucose at 120 Minutes Test meal 2 (HGLP meal)	0.8 mmol/l Standard Deviation 2.7
Glucose at 120 Minutes Test meal 3 (MGL meal)	2.5 mmol/l Standard Deviation 3.1
Glucose at 120 Minutes Control meal	2.4 mmol/l Standard Deviation 3.6

SECONDARY outcome

Timeframe: 150 minutes

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

Postprandial glucose excursion taken from CGM readings at 150 minutes after the meal commenced

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Glucose at 150 Minutes Test meal 1 (HGL meal)	1.5 mmol/l Standard Deviation 3.9
Glucose at 150 Minutes Test meal 3 (MGL meal)	1.7 mmol/l Standard Deviation 3.2
Glucose at 150 Minutes Control meal	1.8 mmol/l Standard Deviation 3.3
Glucose at 150 Minutes Test meal 2 (HGLP meal)	0.2 mmol/l Standard Deviation 2.5

SECONDARY outcome

Timeframe: 180 minutes

Population: CGM data for 25 participants who consumed breakfast test and control meals on two occasions. Not all the participants tested all the meals and not all repeated meals. Test meal 1 (HGL): 42 meals, participants: 24. Test meal 2 (HGLP): 36 meals, participants: 20. Test meal 3 (MGL): 37 meals, participants:20, control meals: 34 meals, participants: 20

Postprandial glucose excursion taken from CGM readings at 180 minutes after the meal commenced

Outcome measures

Measure	Breakfast Meals n=149 Breakfast meals Test and control meals
Glucose at 180 Minutes Test meal 1 (HGL meal)	0.9 mmol/l Standard Deviation 3.3
Glucose at 180 Minutes Test meal 2 (HGLP meal)	-0.3 mmol/l Standard Deviation 2.2
Glucose at 180 Minutes Test meal 3 (MGL meal)	0.9 mmol/l Standard Deviation 3.1
Glucose at 180 Minutes Control meal	0.9 mmol/l Standard Deviation 2.9

Adverse Events

Breakfast Meals

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