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

This study has been completed.
Sponsor:
Collaborator:
Forschungsinstitut der Diabetes Akademie Mergentheim
Information provided by (Responsible Party):
Insuline Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01352767
First received: May 11, 2011
Last updated: September 4, 2014
Last verified: May 2012

May 11, 2011
September 4, 2014
July 2011
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01352767 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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

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".

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus With Diabetic Neuralgia
Device: InsuPad
Heating pad
  • Experimental: InsuPad Device
    Use of the InsuPad which heats the injection site.
    Intervention: Device: InsuPad
  • No Intervention: CONTROL
    no treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients aged 18 to 70 years (values included)
  • Type 1 diabetes mellitus or insulin treated type 2 diabetes with daily insulin demand ≥ 0.7 units per kg bodyweight.
  • 6% ≤ HbA1c ≤ 9.5%
  • Use of short-acting prandial insulin analogues with injections
  • Study subject is willing to perform at least 5 blood glucose measurements per day for at least 56 days, willing to comply with study procedures and to keep a detailed patient log book.
  • Willing to sign informed consent

Exclusion Criteria:

  • Excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
  • Known gastro- or enteroparesis.
  • Unstable chronic disease other than type 1 diabetes (e.g. Unstable angina factoris, , renal disease) for the last six months before study start.
  • Severe hypoglycemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start.
  • Hypoglycaemia unawareness (Score > 4 in the Hypoglycaemia Awareness Questionnaire, see appendix)
  • Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start
  • Any known life-threatening disease
  • Pregnant women, lactating women or women who intend to become pregnant during the observation period
  • Any other condition or compliance issues that might interfere with study participation or results
  • Subjects with heat sensitivity
  • Subjects involved in or planed to participate in other studies
  • Subjects who are incapable of contracting or under guardianship
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01352767
CP-PP-002
No
Insuline Medical Ltd.
Insuline Medical Ltd.
Forschungsinstitut der Diabetes Akademie Mergentheim
Not Provided
Insuline Medical Ltd.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP