Additional Insulin for Fat and Protein in Children With Diabetes Study

• Status: Terminated
• Trial end date: 2018-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxford University Hospitals NHS Trust
• Treatments: Insulin; Insulin Aspart; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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