Pilot study to evaluate glycemic control withGlucoTab using an ultra-long acting insulinanalogue in non-critically ill patients with type 2diabetes at the general ward
Phase 4
- Conditions
- E11Type 2 diabetes mellitus
- Registration Number
- DRKS00011487
- Lead Sponsor
- niversitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Diabetologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
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 antidiabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycemia which requires s.c insulin therapy
Exclusion Criteria
Type 1 Diabetes or gestational diabetes
Any disease or condition which the investigator feels would interfere with the trial or the safety of the patient
Pregnancy
Any mental condition rendering the patient incapable of giving his consent
Continous parenteral nutrition
Participation in another clinical study which can influence the software algorithm
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method umber of hypoglycemic episodes.<br>Number of blood glucose measurements per day.<br>Number of missed blood glucose measurements per day.<br>Number of additionally required blood glucose measurements. <br>Insulin dose-Bolus, basal and corrective insulin dose per day.<br>Number of insulin injections per day.<br>Number and reasons for non-performance of insulin injections per day.<br>Relevant concomitant medication (corticosteroids, parenteral nutrition, oral hypoglycemic agents).<br>Adherence to the insulin dose suggestion of the GlucoTab System.