The InsuPad in Daily Life Study - Effect of Local Heating on Postprandial Glucose Excursions Using the InsuPad Device
Type 1 Diabetes Mellitus With Diabetic Neuralgia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomised, Controlled, Cross-over Study With Inpatient and Outpatient Phases|
- efficacy [ Time Frame: 2 hours ] [ Designated as safety issue: No ]AUC120 BG (area under the curve of postprandial glucose change 2 hours after meal) after breakfast and dinner under standardized conditions during the inpatient phase.
- Efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Mean change in post prandial glucose level at 90 minutes during the outpatient phase.
- Efficacy [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]AUC60 Ins (area under the curve of insulin concentration change 1 hour after meal) after breakfast and dinner under standardized conditions during the inpatient phase.
- Safety [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]• Number and severity of hypoglycaemias and hyperglycaemias and assessment of relationship to the use of the InsuPad device during the whole study.
- Satisfaction [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]• Patient satisfaction (subjective clinical performance) at the end of the study
|Study Start Date:||July 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: InsuPad Device
Use of the InsuPad which heats the injection site.
No Intervention: CONTROL
A randomised, controlled, cross-over study with inpatient and outpatient phases. The inpatient phase length will be two days, which include a "Control" day without activating the InSuPad and a "Test" day where the InsuPad is activated. The outpatient phase length is 8 weeks: 4 weeks without the device-"Control", and 4 weeks with the device-"Test". Each subject will be randomly selected into one of two groups, group "A" and group "B". Forty (40) type I subjects who are meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.
During the inpatient phase subjects will have standardized breakfast and dinner and venous blood samples will be taken for insulin and blood glucose measurements. Comparison of the two days ("control" and "test") will enable us to evaluate the effect of the device on post prandial glucose levels and insulin levels.
During the outpatient (daily life) phase subjects will be required to perform at least 5 self blood glucose measurements (SMBG), three before each meal and two at 90 minutes post breakfast and dinner. Comparing the SMBG measurement from the two periods will enable us to evaluate the effect of the device on post prandial glucose levels. The subjects will be contacted over the phone by the study staff to verify compliance with the protocol.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352767
|Bad Mergentheim, Germany|