Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
Primary Purpose
Diabetes Mellitus, Insulin-Dependent
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
InsuPatch
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Insulin-Dependent focused on measuring MiniMed paradigm insulin pumps, insulin Lispro, Insulin Asprt.
Eligibility Criteria
Inclusion Criteria:
- Age between 18- 65 years old (including = 18 years and =65 years)
- Gender: men and women
- BMI: 18-35 kg/m2
- Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart.
- Diabetic subjects with HbA1c values below 9.5% (including 9.5%).
- Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed
- Subject is willing to comply with all specified follow-up evaluations -
Exclusion Criteria:
- Pregnancy
- Breast feeding women.
- Alcohol addiction
- Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date
- Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study
- Suffer from uncontrolled Hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic)
- Low blood hemoglobin concentration <9 g/dL for female and <11g/dL for male.
- Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values.
- Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH>5.5 mIU/L or TSH<0.4 mIU/L
- Psychological incompetence
- Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant.
- Subjects with diminished skin integrity
- Subjects with heat sensitivity
- Subjects involved in or planed to participate in other studies
- Subjects using other drugs therapies to control blood glucose level other than insulin.
Sites / Locations
- Mills-Peninsula Health Services
- Wolfson Medical Center
- Haddasah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Device
Control
Arm Description
Subject starts with two clamps including device use follows by a clamp without device use
Subject starts with clamps without device
Outcomes
Primary Outcome Measures
Efficacy
Determination of insulin delivery to the blood as measured by Insulin levels in the blood derived from blood samples collected at pre-specified time points during the glucose clamp test.
Safety
frequency and severity of all treatment-related adverse events until the completion of the study.
Secondary Outcome Measures
pharmacokinetics
Cmax PK which is the highest concentration of insulin reached derived from blood samples collected at pre-specified time points during the glucose clamp test
Pharmacodynamic
Tmax PD which is the time of highest glucose infusion rate (GIR) derived from blood samples collected during the glucose clamp test
Full Information
NCT ID
NCT01216618
First Posted
October 5, 2010
Last Updated
September 3, 2014
Sponsor
Insuline Medical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01216618
Brief Title
Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
Official Title
Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insuline Medical Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a prospective, multi-center, open label, randomized; two-arms cross over study.
This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.
Detailed Description
Fifty five(55) type 1 IDDM subjects in three centers who use the MiniMed paradigm insulin pump, meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.
The study will be done with subjects randomized into one of two procedure sequences. Each subject will undergo 3 procedures (two clamps with the InsuPatch and one clamp without the InsuPatch) and will thus serve as his/her own control. The same 55 subjects will be randomized into one sequence or the other. The order of the procedures will be selected randomly and will be performed both within one month.
There will be six Device visits starting with a screening and randomization visit, 3 clamps and a completion visit.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Insulin-Dependent
Keywords
MiniMed paradigm insulin pumps, insulin Lispro, Insulin Asprt.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device
Arm Type
Experimental
Arm Description
Subject starts with two clamps including device use follows by a clamp without device use
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subject starts with clamps without device
Intervention Type
Device
Intervention Name(s)
InsuPatch
Intervention Description
the InsuPatchTM device includes a heating pad and electronics. The heating pad is attached to an existing insulin infusion set by a simple procedure.
Primary Outcome Measure Information:
Title
Efficacy
Description
Determination of insulin delivery to the blood as measured by Insulin levels in the blood derived from blood samples collected at pre-specified time points during the glucose clamp test.
Time Frame
Up to 5 hours
Title
Safety
Description
frequency and severity of all treatment-related adverse events until the completion of the study.
Time Frame
Up to one month
Secondary Outcome Measure Information:
Title
pharmacokinetics
Description
Cmax PK which is the highest concentration of insulin reached derived from blood samples collected at pre-specified time points during the glucose clamp test
Time Frame
Up to 5 hours
Title
Pharmacodynamic
Description
Tmax PD which is the time of highest glucose infusion rate (GIR) derived from blood samples collected during the glucose clamp test
Time Frame
Up to 5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18- 65 years old (including = 18 years and =65 years)
Gender: men and women
BMI: 18-35 kg/m2
Type 1 Insulin dependent diabetes using the MiniMed paradigm insulin pumps for at least six months and using insulin Lispro or Insulin Aspart.
Diabetic subjects with HbA1c values below 9.5% (including 9.5%).
Subject understands the study requirements and the treatment procedures and has signed an Informed Consent before any study-specific tests or procedures are performed
Subject is willing to comply with all specified follow-up evaluations -
Exclusion Criteria:
Pregnancy
Breast feeding women.
Alcohol addiction
Had CABG (Coronary Artery Bypass Graft), are Post MI (Myocardial Infarction) or had active Ischemic heart disease prior to the study date
Had CVA (cardiovascular accident) or TIA (transient ischemic accident) prior to the study
Suffer from uncontrolled Hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic)
Low blood hemoglobin concentration <9 g/dL for female and <11g/dL for male.
Abnormal kidney and/ or liver function tests. (If any of the liver or kidney function test parameters are greater than 3 fold normal values.
Subjects with Hyperthyroidism or Hypothyroidism with TSH level outside the normal range, TSH>5.5 mIU/L or TSH<0.4 mIU/L
Psychological incompetence
Any other clinical condition or history, that seems to be relevant to the principle investigator to disqualify the participant.
Subjects with diminished skin integrity
Subjects with heat sensitivity
Subjects involved in or planed to participate in other studies
Subjects using other drugs therapies to control blood glucose level other than insulin.
Facility Information:
Facility Name
Mills-Peninsula Health Services
City
San Mateo
State/Province
California
ZIP/Postal Code
94401
Country
United States
Facility Name
Wolfson Medical Center
City
Holon
Country
Israel
Facility Name
Haddasah Medical Organization
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Links:
URL
http://www.insuline-medical.com
Description
Sponsor's Official web site
Learn more about this trial
Evaluation of the Effect of the InsuPatch Device on Insulin Pharmacokinetics in Clamp Studies
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