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 | 20.0 |
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 acceptance of the GlucoTab@MobileCare system for glycaemic management in patients with type 2 diabetes receiving domiciliary nursing care
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E.2.2 | Secondary objectives of the trial |
To investigate usability, safety and efficacy parameters of the basal-insulin algorithm incorporated in the GlucoTab@MobileCare system for glycaemic management in patients with type 2 diabetes receiving domiciliary nursing care |
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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 insulin therapy) Receiving domiciliary nursing care by the OERK Graz |
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E.4 | Principal exclusion criteria |
• Type 1 diabetes • Instable corticosteroid therapy • Any disease or condition which the investigator feels would interfere with the trial or the safety of the patient • Any mental condition rendering the patient incapable of giving his/her consent • intravenous insulin therapy • hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy • Gestational diabetes or pregnancy • Known or suspected allergy to certain insulin types • Terminally ill patients • total parenteral nutrition (TPN) • Participation in another trial which could influence the basal-insulin algorithm
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E.5 End points |
E.5.1 | Primary end point(s) |
The percentage of actions the system supports either to capture BG values or provide insulin dose suggestions according to the basal insulin algorithm. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Length of GlucoTab@MobileCare treatment |
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E.5.2 | Secondary end point(s) |
• Number of BG values below individual glycaemic target range according to health status (plus time of day) • Number of blood glucose measurements per day • Insulin dose (Total daily dose (TDD), basal insulin dose, bolus insulin dose) • Number of insulin injections per day • Number of non-performed insulin injections per day • Type of start (according to algorithm OR as judged by physician) • Number of adverse events, device-related adverse events and serious adverse events • Differences between BG values entered in GlucoTab@MobileCare and BG values recorded by AccuChek® Guide
• User satisfaction with the GlucoTab@MobileCare system regarding the user interface and the provided functionality • Other usability parameters like user workload and support of treatment workflow • Physician adherence to insulin starting dose suggestion (according to algorithm OR as judged by physician) • Nurse adherence to suggested basal-insulin adjustment/titration dose • Nurse adherence to suggested basal-insulin injection dose • Nurse adherence to suggested timing 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 • Nurse adherence to suggested short-acting insulin injection dose • Patient/relative usability/practicability parameters as assessed by questionnaire at the end of trial • Nurse usability/practicability parameters as assessed by questionnaire before start and at the end of trial
• Mean percentage of FBGs in the FBG target range according to health status calculated by all FBGs measured ≥ 24 hours after start of therapy • Mean pre-breakfast blood glucose, mean pre-lunch blood glucose, mean pre-dinner blood glucose, mean daily pre-meal blood glucose (calculated if at least 3 pre-meal BG values per day available): overall and per treatment day • Number and percentage of values 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 • Insulin starting dose • Final insulin dose • Number and percentage of FBGs < FBG target or > FBG target • Days with FBGs in target (according to health status)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Length of GlucoTab@MobileCare 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.8.2.4 | 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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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 | |