Status:
COMPLETED
Evaluation of Glycaemic Control Using GlucoTab® With Insulin Degludec in Hospitalized Patients With Diabetes Mellitus Type 2
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The GlucoTab® system is a computerized decision support system built of an android based front-end user interface and a backend server including the REACTION algorithm. GlucoTab® is able to process bl...
Eligibility Criteria
Inclusion
- Written informed consent after being advised of every detail of the study
- Male or female sex
- Aged ≥ 18 years
- Known history of diabetes of at least 90 days
- Type 2 diabetes mellitus treated with either diet alone or any combination of oral antidiabetic agents and the absence of diabetic ketoacidosis for at least 90 days.
- HbA1c 6.5 - 10.0%
Exclusion
- Type 1 diabetes mellitus
- Gestational diabetes mellitus
- Pregnancy or currently breast-feeding women
- Known or suspected allergy to insulin degludec and/or insulin aspart
- Continuous parenteral nutrition
- Participation in another trial which may in the opinion of the investigator interfere with the software algorithm
- Any mental condition rendering the patient incapable of giving informed consent
- Any disease or condition which in the opinion of the investigator would interfere with the trial performance and/or the physical and/or psychosocial safety of the study participant
- Critically ill patients
Key Trial Info
Start Date :
January 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03387787
Start Date
January 30 2018
End Date
January 30 2020
Last Update
March 16 2023
Active Locations (1)
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1
Division of Endocrinology, Diabetes, Clinical Nutrition & Metabolism, University Hospital Berne, Switzerland
Bern, Switzerland, 3010