Additional Insulin for Fat and Protein in Children With Diabetes Study

NCT02680054 | Terminated Phase 4 Results

• 2 other identifiers: 1141852015-003666-85
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

The aims of the study are to see if additional insulin doses for the fat and protein in a meal, given at different times, improve blood glucose levels and are safe and acceptable to children with Type 1 diabetes using multiple daily insulin injections.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• Peak Glucose Level Following Test Meal

  Glucose measured on the continuous subcutaneous glucose monitor

  assessed up to 12 hours following the test meal

• Peak Glucose Excursion From Baseline Following Test Meal

  Glucose measured on the continuous subcutaneous glucose monitor

  assessed up to 12 hours following the test meal

• Time of Peak Glucose Level Following Test Meal

  Glucose measured on the continuous subcutaneous glucose monitor

  assessed up to 12 hours following the test meal

Secondary Outcomes (1)

• Number of Participants With Hypoglycaemia Events Following the Insulin Dosing

  assessed up to 12 hours following the test meal

Other Outcomes (1)

• Acceptability of Giving Insulin at Different Times Related to Test Meal

  questionnaires completed up to a week after the test meals

Study Arms (3)

Arm 1 (usual treatment)

ACTIVE COMPARATOR

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.

Drug: Insulin, Asp(B28)-

Arm 2

ACTIVE COMPARATOR

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.

Drug: Insulin, Asp(B28)-

Arm 3

ACTIVE COMPARATOR

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.

Drug: Insulin, Asp(B28)-

Interventions

Insulin, Asp(B28)- DRUG

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

Also known as: NovoRapid

Arm 1 (usual treatment); Arm 2; Arm 3

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of Type 1 diabetes (for at least a year)
• On multiple daily insulin injections, including basal long-acting insulin and rapid-acting insulin before each meal.
• HbA1c \< 75 mmol/mol (9.0%)
• Participant and/or parent/legal guardian willing and able to give informed consent for participation in the study.
• Family have a freezer in which to safely store the test meals.
• In the Investigator's opinion, is able and willing to comply with all trial requirements.

You may not qualify if:

• HbA1c greater than 75 mmol/mol (9.0%)
• Child unwilling to agree to second insulin injection at a meal-time
• Untreated coeliac disease or other concomitant condition likely to affect BG control
• Food allergies (other than controlled Coeliac Disease)
• Vegetarians, vegans or patients with religious dietary restrictions (as the standard meal contains meat)
• Participant taking any glucose-containing medication concurrently

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (2)

Royal Berkshire Hospital

Reading, Berkshire, United Kingdom

Location

Oxford Children's Hospital, John Radcliffe Hospital

Oxford, Oxon, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr Rachel Besser
• Organization: Oxford University Hospitals NHS Trust

rachel.besser@ouh.nhs.uk

01865 741741

Study Officials

• Rachel E Besser, PhD

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Paediatric Diabetes

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 11, 2016
• Study Start: February 1, 2016
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Locations

GB (2)