This is the test protocol for the InsuPad device. The aim of the study is to show economical benefit when using the InsuPad device, by testing the effect of the InsuPad device on reducing injected insulin dose while keeping the same overall glycaemic control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
145
Use of the InsuPad for at least 3 times a day.
Gemeinschaftspraxis Dr. Klausmann/ Dr. Welslau
Aschaffenburg, Germany
Diabeteszentrum Bad Mergentheim
Bad Mergentheim, Germany
ikfe GmbH, Berlin
Berlin, Germany
GWT-TUD GmbH, Zentrum für Klinische Studien
Dresden, Germany
Efficacy
The primary endpoint of the study is to demonstrate the non-inferiority (margin of 0.4%) for overall glycaemic control defined as HbA1c of a treatment regimen applying InsuPad combined with an insulin dose reduction of \>10% in the test group compared to the control group not using InsuPad.
Time frame: 3 months
Safety
compare the Frequency of mild hypoglycaemia events (Blood Glucose \< 63 mg/dl or 3. 5 mmol/l) with InsuPad and without InsuPad.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ikfe GmbH Mainz
Mainz, Germany
Zentrum Für Klinische Studien Neuwied
Neuwied, Germany
ikfe GmbH, Potsdam
Potsdam, Germany
Dr. Notghi Clinical Trials
Potsdam, Germany
Allgemeinärztliche Berufsausübungs-gemeinschaft Waldfischbach-Burgalben
Waldfischbach-Burgalben, Germany