E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes mellitus type 2 |
Diabetes mellitus Typ 2 |
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E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes |
Typ 2 Diabetes |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10053247 |
E.1.2 | Term | Insulin-requiring type 2 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067585 |
E.1.2 | Term | Type 2 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 |
To investigate the efficacy of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at different general wards |
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E.2.2 | Secondary objectives of the trial |
To investigate safety, usability and further efficacy parameters of the GlucoTab system. |
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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 years
- Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycaemia which requires s.c. insulin therapy
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E.4 | Principal exclusion criteria |
- Type 1 diabetes, gestational diabetes
- Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
- Pregnancy
- Any mental condition rendering the patient incapable of giving his consent
- Known or suspected allergy to insulin glargine or insulin aspart
- Continuous parenteral nutrition
- Participation in another trial which can influence the software algorithm |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured ≥ 24 hours after start of therapy. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Length of GlucoTab treatment |
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E.5.2 | Secondary end point(s) |
Safety:
- Number of hypoglycaemic episodes requiring third party help
- Number of blood glucose measurements per day
- Number of missed blood glucose measurements per day
- Number of additionally required blood glucose measurements
- Insulin dose - basal, bolus and corrective insulin dose per day
- Number of insulin injections per day
- Number and reasons for non-performance of insulin injections per day
- Relevant concomitant medication (corticosteroids, parenteral bolus nutrition)
Usability:
- Adherence to the insulin dose suggestion of the GlucoTab system
- User satisfaction with the GlucoTab system regarding the user interface and the provided functionality
- Malfunctions of the GlucoTab system
- Other usability parameters like user workload and support of treatment workflow
Efficacy:
- Mean daily blood glucose as calculated by premeal and bedtime glucose values: Overall and per treatment day.
- Mean pre-breakfast blood glucose, mean pre-lunch blood glucose, mean pre-dinner blood glucose, mean bedtime blood glucose
- Mean pre-enrolment blood glucose
- Number and percentage of the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<100 mg/dl, 100-140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl.
- Time of glucose measurements in the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<100 mg/dl, 100-140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Length of GlucoTab treatment |
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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 | 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
| 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 | 5 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |