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

NCT ID: NCT01283425

Last Updated: 2014-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-04-30

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Test

InsuPatch use for 3 months.

Group Type: EXPERIMENTAL

InsuPatch

Intervention Type: DEVICE

Heaters for single use and a permanent control unit.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

InsuPatch

Heaters for single use and a permanent control unit.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject's age range 18- 65 years old (including 18 and 65 years old)

2. BMI: 18-35 kg/m2

3. 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.

4. Patients with T1DM whose HbA1c values are at or below 9.5% (including 9.5%) and at or above 6% (including 6%).

5. Agree to sign consent form before any study-specific tests or procedures are to be performed.

6. 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.

7. Subject readiness to use the InsuPatch, his comprehension of the study requirements and treatment procedures.

8. Willingness to comply with all specified follow-up evaluations.

Exclusion Criteria

1. Pregnancy

2. Breast feeding women.

3. Alcohol addiction

4. CABG (Coronary Artery Bypass Graft), MI (Myocardial Infarction) or active Ischemic Heart Disease prior to study date.

5. CVA (cardiovascular accident) or TIA (transient ischemic accident) events prior to study date.

6. Uncontrolled hypertension (blood pressure in mm HG >160 systolic or > 95 diastolic) .

7. Any history of gastroparesis or enteroparesis.

8. Abnormal kidney and/ or liver function tests. (Defined as Creatinine >1.5 mg/dL, liver tests> 2 times the upper limit of normal).

9. A severe hypoglycemic event requiring a glucagon injection or intravenous glucose infusion within the last six months prior to study inclusion.

10. Hypoglycemia unawareness.

11. Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study inclusion.

12. Psychological incompetence.

13. Signs of drug abuse.

14. Any other clinical condition or history, which seems to be relevant for the Principle Investigator to disqualify a participant.

15. Subjects with diminished skin integrity, Excessive fibrosis, lipo-hypertrophy or eczema at infusion sites.

16. Heat sensitive subjects.

17. Subjects involved in or planning to participate in other studies.

18. Subjects using any drug therapy, other than insulin, to control their blood glucose levels.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insuline Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wainstein Julio, MD

Role: PRINCIPAL_INVESTIGATOR

Wolfsom Medical Center, Holon, Israel

Itamar Raz, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Klonoff David, MD

Role: PRINCIPAL_INVESTIGATOR

Mills Peninsula Health Services

Naim Shhada, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Orit Hamiel, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Moshe Philips, MD

Role: PRINCIPAL_INVESTIGATOR

Schnieder Children's Medical Center

Anat Yaffe, Md

Role: PRINCIPAL_INVESTIGATOR

Hiullel Yaffe Medical Center

Locations

Mills-Peninsula Health Services

San Mateo, California, United States

Soroka Medical Center

Beersheba, , Israel

Hillel Yaffe

Hadera, , Israel

Rambam Medical Center

Haifa, , Israel

Wolfson Medical Center

Holon, , Israel

Haddasah Medical Organization

Jerusalem, , Israel

Schneider Children's hospital

Petah Tikva, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Countries

United States; Israel

Related Links

http://www.insuline-medical.com

Related Info

Other Identifiers

G080106/B

Identifier Type: -

Identifier Source: org_study_id