NCT01352767

The InsuPad in Daily Life Study - Effect of Local Heating on Postprandial Glucose Excursions Using the InsuPad Device

A Randomised, Controlled, Cross-over Study With Inpatient and Outpatient Phases

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Insuline Medical Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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".

Detailed description

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.

Conditions

• Type 1 Diabetes Mellitus With Diabetic Neuralgia

Interventions

Type	Name	Description
DEVICE	InsuPad	Heating pad

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-05-12
• Last updated: 2014-09-05

Locations

1 site across 1 country: Germany