E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Insulin-dependent diabetes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067584 |
E.1.2 | Term | Type 1 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
What is the best timing of extra insulin doses for the fat and protein content of the meal to optimise post-prandial blood glucose levels in children using multiple daily injections?
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E.2.2 | Secondary objectives of the trial |
To examine other indices of BG control following additional insulin boluses for the fat and protein content of a meal given before, one or two hours after a meal in children with Type 1 diabetes using multiple daily injections.
Is it acceptable and is it safe to give extra insulin injections for fat and protein content of high protein and high fat meals to children aged 6 to 17 years?
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• 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.
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
What is the best timing of extra insulin doses for the fat and protein content of the meal to optimise post-prandial blood glucose levels in children using multiple daily injections?
Continuous subcutaneous glucose profiles will be examined to determine the mean post-prandial glucose excursion for 8 hours following the test meal
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E.5.2 | Secondary end point(s) |
To examine other indices of BG control following additional insulin boluses for the fat and protein content of a meal given before, one or two hours after a meal in children with Type 1 diabetes using multiple daily injections.
Is it acceptable and is it safe to give extra insulin injections for fat and protein content of high protein and high fat meals to children aged 6 to 17 years?
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial months | 12 |
E.8.9.2 | In all countries concerned by the trial days | 1 |