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 | 19.1 |
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 compare efficacy of the basal-insulin algorithm (decision support) with computerized documentation (without decision support) incorporated in the GlucoTab system for glycaemic management in patients with type 2 diabetes at acute geriatric care wards |
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E.2.2 | Secondary objectives of the trial |
To investigate usability, safety and further efficacy parameters of the new basal-insulin algorithm (decision support) and the computerized physician-based documentation (no decision support) incorporated in the GlucoTab system for glycaemic management in patients with type 2 diabetes at acute geriatric care wards |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female aged ≥ 65 years Planned minimum stay of 1 week Insulin planned as inpatient and/or discharge therapy Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four)
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E.4 | Principal exclusion criteria |
Instable corticosteroid therapy (>5 mg per day) Known or suspected allergy to insulin glargine/ glulisine Parenteral nutrition
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean percentage of FBGs in the FBG target range according to health status calculated by all FBGs measured ≥ 24 hours after start of therapy |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Lenght of GlucoTab treatment |
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E.5.2 | Secondary end point(s) |
• Number of episodes below individual glycaemic target range according to health status (plus time of day) • Number of blood glucose measurements per day • Insulin dose (TDD of basal vs. bolus vs. premixed insulin) • Number of insulin injections per day • Number of non-performed insulin injections per day • Insulin starting dose • Insulin end-dose • Type of start (according to known dose/ according to new calculation OR as judged by physician) T • Number of falls • Number of adverse events, device-related adverse events and serious adverse events
• Adherence to insulin starting dose suggestion (known dose/ new calculation) • Adherence to suggested long-acting insulin titration dose • Adherence to suggested long-acting insulin injection dose • Adherence to suggested time point of adjustment/titration • Number of missed blood glucose measurements per day • Number of additionally performed blood glucose measurements per day • Adherence to suggested BG measurement frequency • Adherence to suggested therapy change/end of algorithm • Adherence to suggested short-acting insulin injection dose • User satisfaction with the GlucoTab system regarding the user interface and the provided functionality/ Other usability parameters like user workload and support of treatment workflow • Medical prescription available • Number of Log-Ins • Number of therapy adaptations/changes • Number of MD consultation by nurses
• Mean pre-breakfast blood glucose, mean pre-lunch blood glucose, mean pre-dinner blood glucose, mean bedtime blood glucose: overall and per treatment day • Mean daily pre-meal blood glucose (calculated if at least 3 pre-meal BG values per day available) • Mean pre-breakfast pre-basal insulin therapy BG • Mean pre-meal pre-basal insulin therapy BG (calculated if at least 3 values per day) • Number and percentage of the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<90 mg/dl, 90-<100 mg/dl, 90-260 mg/dl; 90-300 mg/dl; 100-350 mg/dl; >261-<300 mg/dl, 300-<350 mg/dl, ≥ 350 mg/dl • Time of glucose measurements in the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<90 mg/dl, 90-<100 mg/dl, 90-260 mg/dl; 90-300 mg/dl; 100-350 mg/dl; >261-<300 mg/dl, 300-<350 mg/dl, ≥ 350 mg/dl • Number and percentage of FBGs < FBG target or > FBG target • Days in target (according to health status) • Time in target (according to health status) • Glucose variability as assessed by CGM data • Type of diabetes medication
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Lenght 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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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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LPLV Last Patient Last Visit |
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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 | 11 |
E.8.9.1 | In the Member State concerned days | |