E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes mellitus type 2 |
Diabetes mellitus Typ 2 |
|
E.1.1.1 | Medical condition in easily understood language |
Type 2 diabetes |
Typ 2 Diabetes |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
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 (safety) of the new GlucoTab system in non-critically ill patients with type 2 diabetes at the general ward for the length of hospital stay, with a maximum of 21 days. |
|
E.2.2 | Secondary objectives of the trial |
To investigate usability and efficacy of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward for the length of hospital stay, with a maximum of 21 days. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed consent obtained after being advised of the nature of the study
2. Male or female aged 18 - 90 years (both inclusive)
3. Type 2 diabetes treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four |
1. Informed consent obtained after being advised of the nature of the study
2. Männliche oder weibliche Patienten im Alter von 18 - 90 Jahren (beides inklusive)
3. Typ 2 Diabetes behandelt mit Diät, orale Antibetika, nicht-insulinartige injizierbare antdiabetische Medika, Insulintherapie oder jegliche Kombination der genannten vier Therapiemöglichkeiten |
|
E.4 | Principal exclusion criteria |
1. Impaired renal function (serum creatinine ≥3.0mg/dL)
2. Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
3. Pregnancy
4. Any mental condition rendering the patient incapable of giving his consent
5. Terminally ill patients
6. Participation in a trial within 3 months prior to this trial
7. Known or suspected allergy to insulin |
1. Eingeschränkte Nierenfunktion (Serumkreatinin ≥3.0mg/dL)
2. Jegliche Krankheit oder Zustand der laut dem Prüfer oder behandelnden Arzt die Studie oder die Sicherheit des Patienten beeinflussen würde
3. Schwangerschaft
4. Jeglicher Bewusstseinszustand durch den der Patient nicht in der Lage ist seine Zustimmung zur Teilnahme an der Studie zu geben
5. Patienten in der letzten Lebensphase
6. Teilnahme an einer Studie innerhalb der letzten 3 Monate vor Einschluss in diese Studie
7. Bekannte oder suspizierte Insulinallergie |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of actions the GlucoTab system supports either to capture BG values or provide insulin dose suggestions according to the REACTION algorithm. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At hospital discharge / transfer to other ward/department / if study
period exceeds 21 days |
|
E.5.2 | Secondary end point(s) |
Safety and Usability
• Hypoglycaemia and possible attendant clinical symptoms, hypoglycaemic episodes requiring third party help
• Number of blood glucose measurements per day, number of missed glucose measurements per day
• Number and reasons for additionally required blood glucose measurements
• Insulin dose - basal, bolus and supplemental insulin dose per day
• Number of insulin injections per day
• Number and reasons for non-performance of insulin injections per day
• Adherence to the GlucoTab system
• Malfunctions of the GlucoTab system
• Other usability parameters like workload and workflow of treatment
• Number of meals per day
• Relevant concomitant medication (corticosteroids, continuous parenteral nutrition)
Efficacy:
• Mean blood glucose as calculated by premeal and bedtime glucose values per treatment day
• Mean daily blood glucose as calculated by blood glucose values per treatment day
• Pre-enrolment blood glucose
• Number of glucose measurements in target (100-140 mg/dl), low-normal range (70–99 mg/dl, hypoglycaemic ranges (40-<70 mg/dl, <40mg/dl) high-normal range (>140-180 mg/dl, and hyperglycaemic ranges 180-<300 mg/dl, ≥300 mg/dl)
• Time of glucose measurements in target (100-140 mg/dl), low-normal range (70–99 mg/dl, hypoglycaemic ranges (40-<70 mg/dl, <40 mg/dl) high-normal range (>140-180 mg/dl, and hyperglycaemic ranges 180-<300 mg/dl, ≥300 mg/dl) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At hospital discharge / transfer to other ward/department / if study
period exceeds 21 days |
|
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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
|
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
|
|
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 | 5 |
E.8.9.1 | In the Member State concerned days | 0 |