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

Primary Purpose

Type 1 Diabetes Mellitus With Diabetic Neuralgia

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
InsuPad
Sponsored by
Insuline Medical Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus With Diabetic Neuralgia focused on measuring insulin injection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bad Mergentheim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

InsuPad Device

CONTROL

Arm Description

Use of the InsuPad which heats the injection site.

no treatment

Outcomes

Primary Outcome Measures

efficacy
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.

Secondary Outcome Measures

Efficacy
Mean change in post prandial glucose level at 90 minutes during the outpatient phase.
Efficacy
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
• Number and severity of hypoglycaemias and hyperglycaemias and assessment of relationship to the use of the InsuPad device during the whole study.
Satisfaction
• Patient satisfaction (subjective clinical performance) at the end of the study

Full Information

First Posted
May 11, 2011
Last Updated
September 4, 2014
Sponsor
Insuline Medical Ltd.
Collaborators
Forschungsinstitut der Diabetes Akademie Mergentheim
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1. Study Identification

Unique Protocol Identification Number
NCT01352767
Brief Title
The InsuPad in Daily Life Study - Effect of Local Heating on Postprandial Glucose Excursions Using the InsuPad Device
Official Title
A Randomised, Controlled, Cross-over Study With Inpatient and Outpatient Phases
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insuline Medical Ltd.
Collaborators
Forschungsinstitut der Diabetes Akademie Mergentheim

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus With Diabetic Neuralgia
Keywords
insulin injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
InsuPad Device
Arm Type
Experimental
Arm Description
Use of the InsuPad which heats the injection site.
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
no treatment
Intervention Type
Device
Intervention Name(s)
InsuPad
Intervention Description
Heating pad
Primary Outcome Measure Information:
Title
efficacy
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Efficacy
Description
Mean change in post prandial glucose level at 90 minutes during the outpatient phase.
Time Frame
8 weeks
Title
Efficacy
Description
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.
Time Frame
8 weeks
Title
Safety
Description
• Number and severity of hypoglycaemias and hyperglycaemias and assessment of relationship to the use of the InsuPad device during the whole study.
Time Frame
14 weeks
Title
Satisfaction
Description
• Patient satisfaction (subjective clinical performance) at the end of the study
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Bad Mergentheim
City
Bad Mergentheim
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.insuline-medical.com
Description
Related Info

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

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