Investigation of Appropriate Timing of Additional Insulin Dosing for Fat and Protein in Children with Type 1 Diabetes using Multiple Daily Injections
- Conditions
- Type 1 diabetesMedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2015-003666-85-GB
- Lead Sponsor
- Oxford University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
•Diagnosis of Type 1 diabetes (for at least a year)
•Aged 6 to under 18 years.
•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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method