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 |
Metabolic disease in which a person has high blood sugar because the body does not produce enough insulin |
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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 | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012608 |
E.1.2 | Term | Diabetes mellitus insulin-dependent |
E.1.2 | System Organ Class | 100000004861 |
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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 |
The aim of this study is to monitor the hydraulic tissue resistance at the subcutaneous tissue sites of infusion of an insulin and insulin-free solution in patients with type 1 diabetes and to determine the frequency distributions of the hydraulic tissue resistance at theses infusion sites over a time period of 7 days. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Type 1 diabetes treated with with continuous subcutaneous insulin infusion
- 18 to 64 years of age, both inclusive
- HbA1C < 10%
- Signed informed consent before any study-related activities |
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E.4 | Principal exclusion criteria |
- Severe acute diseases which the investigator or the acting physician feels would interfere with the trial or the safety of the subject
- Clinically overt diabetic complications
- Mental incapacity, unwillingness, or language barriers precluding adequate understanding or co-operation
- Taking any vasoactive substances or anticoagulatory medication Uncontrolled hypertension
- Diseases of the skin which could interfere with the sensor and the catheter application as judged by the investigator
- Use of a medication that significantly impacts glucose metabolism (i.e. oral or topical steroids) except in the case of a stable state with a minimum duration of at least three months preceding the study as well as under the condition that the state remain stable for the duration of the study
- Pregnancy, breastfeeding, intention of becoming pregnant, or not using adequate contraception
- Any disease or condition which the investigator or the acting physician feels would interfere with the trial or the safety of the subject
- Blood donation within three months preceding the study
- Concurrent participation in another study
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E.5 End points |
E.5.1 | Primary end point(s) |
sTR, specific tissue resistance |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
on each day during the infusion sites usage period of 7 days |
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E.5.2 | Secondary end point(s) |
- TR, tissue resistance
- ΔPTmean, mean pressure increase generated by the tissue during bolus delivery
- ΔPSmean, mean pressure increase generated by the system during bolus delivery
-Pmean, mean pressure observed during bolus delivery
- Rsys, hydraulic resistance exerted by the infusion line only
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
on each day during the infusion sites usage period of 7 days |
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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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Within-subject comparison of the tissue resistance at infusion sites of insulin & placebo solutions |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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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DRop-outs will be replaced. The study is considered complete if 30 eligible patients complete the whole study |
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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |