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 |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] |
MedDRA Classification |
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 |
To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients |
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E.2.2 | Secondary objectives of the trial |
To investigate safety of the software algorithm To investigate the feasibility to continuously monitor blood glucose To simulate to drive the software algorithm by continuous blood glucose data |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Informed consent obtained after being advised of the nature of the study • Male or female aged 18 to 75 years (both inclusive) • The subject has Type 1 diabetes (as defined by WHO) for at least 24 months • The subject's HbA1c <= 10% • Body Mass Index (BMI) <= 35 kg/m2 • The subject is treated with CSII for at least 3 months
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E.4 | Principal exclusion criteria |
• Subject is actively enrolled in another clinical trial or took part in a study within 30 days • Experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator) • Total daily insulin dose >= 1.4 IU/kg • Subject is using a medication that significantly impacts glucose metabolism (oral or topical steroids) except if stable for at least the last three months and expected to remain stable for the study duration • Allergy against insulin Lispro • Subject is on psychiatric medication • A history of drug or alcohol dependence • Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator • Uncontrolled hypertension with resting blood pressure over 140/90 mmHg • Patient is pregnant, or breast feeding during the period of the study • Retinopathy except background retinopathy according to eye fundus examination during the last year • Patient donated blood in the last 3 months |
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E.5 End points |
E.5.1 | Primary end point(s) |
15 min in the predefined glucose ranges: post-prandial phase (3 hours after meal): 70-180 mg/dl (3.9-10 mmol/l), all other phases: 70-140 mg/dl (3.9-7.8 mmol/l) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Every 15 min over a period of 24 hours |
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E.5.2 | Secondary end point(s) |
• Distribution of measured glucose values over the glycaemic range during the entire 24 hour intervention period • Distribution of measured glucose values over the glycaemic range 3 hours after a meal • Number of hypoglycaemic events • Number and reasons for oral glucose intake • Injected insulin dose • Malfunction of the algorithm • Accuracy of the glucose monitoring unit • Difference between the glucose derived from i.v. microdialysis and the corresponding reference glucose |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Every 15 min over a period of 24 hours |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |