Trial Outcomes & Findings for Additional Insulin for Fat and Protein in Children With Diabetes Study (NCT NCT02680054)

NCT ID: NCT02680054

Last Updated: 2020-02-05

Results Overview

Glucose measured on the continuous subcutaneous glucose monitor

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 38 participants
• Primary outcome timeframe: assessed up to 12 hours following the test meal
• Results posted on: 2020-02-05

Participant Flow

Study was closed before target could be reached due to exhaustion of eligible participants

Participant milestones

Measure	All Study Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal, then +1hr after, then +2hr after. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal
Overall Study STARTED	38
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Study Participants n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal, then +1hr, then +2hr. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal
Age, Categorical <=18 years	27 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=27 Participants
Sex: Female, Male Female	12 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=27 Participants
Region of Enrollment United Kingdom	27 Participants n=27 Participants
Duration of T1 Diabetes	3.5 years n=27 Participants

PRIMARY outcome

Timeframe: assessed up to 12 hours following the test meal

Glucose measured on the continuous subcutaneous glucose monitor

Outcome measures

Measure	Arm 1 (Usual Treatment) n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal	Arm 2 n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given one hour after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal	Arm 3 n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given two hours after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal
Peak Glucose Level Following Test Meal	10.931 mmol/l Standard Deviation 0.951	11.491 mmol/l Standard Deviation 0.831	11.491 mmol/l Standard Deviation 0.863

PRIMARY outcome

Timeframe: assessed up to 12 hours following the test meal

Glucose measured on the continuous subcutaneous glucose monitor

Outcome measures

Measure	Arm 1 (Usual Treatment) n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal	Arm 2 n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given one hour after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal	Arm 3 n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given two hours after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal
Peak Glucose Excursion From Baseline Following Test Meal	1.864 mmol/l Standard Deviation 0.716	1.167 mmol/l Standard Deviation 0.72	2.459 mmol/l Standard Deviation 0.712

PRIMARY outcome

Timeframe: assessed up to 12 hours following the test meal

Glucose measured on the continuous subcutaneous glucose monitor

Outcome measures

Measure	Arm 1 (Usual Treatment) n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal	Arm 2 n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given one hour after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal	Arm 3 n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given two hours after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal
Time of Peak Glucose Level Following Test Meal	82.34 Mins Standard Deviation 35.37	113.617 Mins Standard Deviation 30.922	95.106 Mins Standard Deviation 32.092

SECONDARY outcome

Timeframe: assessed up to 12 hours following the test meal

All episodes of hypoglycaemia (BG less than 4 mmol/l) either on continuous glucose monitor or self-monitoring of BG

Outcome measures

Measure	Arm 1 (Usual Treatment) n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal	Arm 2 n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given one hour after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal	Arm 3 n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given two hours after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal
Number of Participants With Hypoglycaemia Events Following the Insulin Dosing	14 Participants	14 Participants	16 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: questionnaires completed up to a week after the test meals

Would young people continue to give extra insulin injections for High Fat High Protein (HFHP) meals

Outcome measures

Measure	Arm 1 (Usual Treatment) n=27 Participants Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given at the same time as the insulin for the carbohydrate content BEFORE the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal	Arm 2 Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given one hour after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal	Arm 3 Insulin dose (insulin Aspart, NovoRapid) for the fat and protein in a high-fat, high-protein meal is given two hours after the meal. The dose is calculated on an individual basis according to the usual insulin to carbohydrate ratio for that child. Insulin, Asp(B28)-: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal
Acceptability of Giving Insulin at Different Times Related to Test Meal	11 Participants	—	—

Adverse Events

Arm 1 (Usual Treatment)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 3

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

Dr Rachel Besser

Oxford University Hospitals NHS Trust

Phone: 01865 741741

Email: rachel.besser@ouh.nhs.uk

Results disclosure agreements

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