A single-centre, open-label, randomized controlled trial of efficacy, safety and usability of a basal insulin algorithm incorporated into the GlucoTab system compared to standard care for glycaemic management in geriatric patients with type 2 diabetes at acute geriatric care wards
- Conditions
- type 2 diabetesE11Type 2 diabetes mellitus
- Registration Number
- DRKS00012553
- Lead Sponsor
- Medizinische Universität GrazKlinische Abteilung für Endokrinologie und Diabetologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 58
Informed consent obtained after being advised of the nature of the study; Male or female aged = 65 years; Planned minimum stay of 1 week; Insulin planned as inpatient and/or discharge therapy; Type 2 diabetes; Fulfilled criteria for admission in acute geriatric care / remobilisation wards;
Instable corticosteroid therapy (>5 mg per day); Known or suspected allergy to insulin glargine/ glulisine; Parenteral nutrition; Participation in another trial which could influence the software algorithm; Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient; Any mental condition rendering the patient incapable of giving his/her consent; Pregnancy;
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean percentage of FBGs in the FBG (fasting blood glucose) target range according to health status calculated by all FBGs measured = 24 hours after start of therapy<br>When: after study has been completed all measured FBGs will be evaluated.<br>The primary endpoint will be measured according to the measured FBGs in the target range<br>The endpoint will be measured by the FBGs that are documented in the GlucoTab system<br>
- Secondary Outcome Measures
Name Time Method umber of episodes below individual glycaemic target range; <br>When: after study has been completed all measured BGs will be evaluated.<br>The endpoint will be measured according to the measured BG values below the target range<br>The endpoint will be measured by the BGs that are documented in the GlucoTab system;<br><br><br>Usability: Adherence to suggested long-acting insulin titration dose <br>When: after study has been completed all data will be evaluated<br>the administered insulin will be compared to the insulin dose suggestion of the GlucoTab system<br>the administered insulin dose will be compared to the insulin dose suggestion of the GlucoTab system - all data are documented in the GlucoTab system<br>