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Evaluation of the Safety Use of the InsuPatch Device in Daily Life Conditions (Daily Life)

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

InsuPatch

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring MiniMed Paradigm insulin pump, insulin Lispro, Insulin Aspart, Quick-set infusion set

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject's age range 18- 65 years old (including 18 and 65 years old)
BMI: 18-35 kg/m2
Type 1 diabetes patients using a MiniMed Paradigm insulin pump for at least six months, who are administering insulin Lispro or Insulin Aspart and are using the Quick-set infusion set.
Patients with T1DM whose HbA1c values are at or below 9.5% (including 9.5%) and at or above 6% (including 6%).
Agree to sign consent form before any study-specific tests or procedures are to be performed.
Subject's completed at least 14 measurements during the Run-In Phase and readiness to continue the study with at least 5 blood glucose recordings per day and keep a logbook during the study period.
Subject readiness to use the InsuPatch, his comprehension of the study requirements and treatment procedures.
Willingness to comply with all specified follow-up evaluations.

Exclusion Criteria:

Pregnancy
Breast feeding women.
Alcohol addiction
CABG (Coronary Artery Bypass Graft), MI (Myocardial Infarction) or active Ischemic Heart Disease prior to study date.
CVA (cardiovascular accident) or TIA (transient ischemic accident) events prior to study date.
Uncontrolled hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic) .
Any history of gastroparesis or enteroparesis.
Abnormal kidney and/ or liver function tests. (Defined as Creatinine >1.5 mg/dL, liver tests> 2 times the upper limit of normal).
A severe hypoglycemic event requiring a glucagon injection or intravenous glucose infusion within the last six months prior to study inclusion.
Hypoglycemia unawareness.
Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study inclusion.
Psychological incompetence.
Signs of drug abuse.
Any other clinical condition or history, which seems to be relevant for the Principle Investigator to disqualify a participant.
Subjects with diminished skin integrity, Excessive fibrosis, lipo-hypertrophy or eczema at infusion sites.
Heat sensitive subjects.
Subjects involved in or planning to participate in other studies.
Subjects using any drug therapy, other than insulin, to control their blood glucose levels.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test

Control

Arm Description

InsuPatch use for 3 months.

Outcomes

Primary Outcome Measures

frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without.

The confirmatory safety endpoint is, for each subject, frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without. The number of events will be assessed from subject logbook and will be compared between two arms.

Secondary Outcome Measures

Frequency of hyperglycemic events (BG>300 mg/dl, Fasting BG>250 mg/dl) with InsuPatch and without.

Frequency of hyperglycemic events (BG>300 mg/dl, Fasting BG>250 mg/dl) with InsuPatch and without.The number of events will be assesed from subject logbook and will be compared between two arms.

Adverse events (AE's) count with InsuPatch and without.

Adverse events (AE's) whether or not deemed related to study device with InsuPatch and without.The number of events will be assesed dering the subject visits and bi-weekly calls and will be compared between two arms.

Full Information

NCT ID

NCT01283425

First Posted

January 19, 2011

Last Updated

September 3, 2014

Sponsor

Insuline Medical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01283425

Brief Title

Evaluation of the Safety Use of the InsuPatch Device in Daily Life Conditions

Acronym

Daily Life

Official Title

An Open-label, Randomized, Two-period Crossover Study to Evaluate the Safety Use of the InsuPatch Device in Daily Life Conditions.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Insuline Medical Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is an open-label, randomized, two-period crossover study. Up to one hundred and twenty (120) subjects with type 1 diabetes mellitus (T1DM) who use the MiniMed paradigm insulin pump, who meet the inclusion/exclusion criteria and who provide written Informed Consent will be enrolled in the study. The aim of the study is to examine the safety of the InsuPatch device in a home use setting. Mild Hypoglycemia,hyperglycemia and Adverse events will be compared between two phases of the study : 3 months with the use of the device and 3 months without the use of the device.

Detailed Description

The primary objective of this study is to show that safety parameters are similar, when delivering insulin subcutaneously in subjects with type I diabetes using the InsuPatch device along with the Medtronic Minimed Paradigm insulin infusion pump and the Medtronic Minimed Quick-Set® infusion set compared to subcutaneous insulin delivered with the above mentioned equipment, without the InsuPatch device. The participation of each subject in this study will be up to seven months and will include three phases: one week Run in phase , 3 months with device use and 3 months without device use. Study will include 4 clinic visits and bi weekly calls. During the entire study the subjects will be requested to preform at least 5 blood glucose self measurements and record results in a logbook.At each visit blood will be drawn for HBA1C test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

MiniMed Paradigm insulin pump, insulin Lispro, Insulin Aspart, Quick-set infusion set

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

147 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test

Arm Type

Experimental

Arm Description

InsuPatch use for 3 months.

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

InsuPatch

Intervention Description

Heaters for single use and a permanent control unit.

Primary Outcome Measure Information:

Title

frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without.

Description

Time Frame

safety will be assesed after 6 months at the study completion

Secondary Outcome Measure Information:

Title

Frequency of hyperglycemic events (BG>300 mg/dl, Fasting BG>250 mg/dl) with InsuPatch and without.

Description

Frequency of hyperglycemic events (BG>300 mg/dl, Fasting BG>250 mg/dl) with InsuPatch and without.The number of events will be assesed from subject logbook and will be compared between two arms.

Time Frame

safety will be assesed after 6 months at the study completion

Title

Adverse events (AE's) count with InsuPatch and without.

Description

Time Frame

safety will be assesed after 6 months at the study completion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject's age range 18- 65 years old (including 18 and 65 years old) BMI: 18-35 kg/m2 Type 1 diabetes patients using a MiniMed Paradigm insulin pump for at least six months, who are administering insulin Lispro or Insulin Aspart and are using the Quick-set infusion set. Patients with T1DM whose HbA1c values are at or below 9.5% (including 9.5%) and at or above 6% (including 6%). Agree to sign consent form before any study-specific tests or procedures are to be performed. Subject's completed at least 14 measurements during the Run-In Phase and readiness to continue the study with at least 5 blood glucose recordings per day and keep a logbook during the study period. Subject readiness to use the InsuPatch, his comprehension of the study requirements and treatment procedures. Willingness to comply with all specified follow-up evaluations. Exclusion Criteria: Pregnancy Breast feeding women. Alcohol addiction CABG (Coronary Artery Bypass Graft), MI (Myocardial Infarction) or active Ischemic Heart Disease prior to study date. CVA (cardiovascular accident) or TIA (transient ischemic accident) events prior to study date. Uncontrolled hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic) . Any history of gastroparesis or enteroparesis. Abnormal kidney and/ or liver function tests. (Defined as Creatinine >1.5 mg/dL, liver tests> 2 times the upper limit of normal). A severe hypoglycemic event requiring a glucagon injection or intravenous glucose infusion within the last six months prior to study inclusion. Hypoglycemia unawareness. Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study inclusion. Psychological incompetence. Signs of drug abuse. Any other clinical condition or history, which seems to be relevant for the Principle Investigator to disqualify a participant. Subjects with diminished skin integrity, Excessive fibrosis, lipo-hypertrophy or eczema at infusion sites. Heat sensitive subjects. Subjects involved in or planning to participate in other studies. Subjects using any drug therapy, other than insulin, to control their blood glucose levels.

Overall Study Officials: