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

This study has been completed.
Sponsor:
Collaborator:
Push-Med LLC.
Information provided by (Responsible Party):
Insuline Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01283425
First received: January 19, 2011
Last updated: May 13, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Device: InsuPatch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Two-period Crossover Study to Evaluate the Safety Use of the InsuPatch Device in Daily Life Conditions.

Resource links provided by NLM:


Further study details as provided by Insuline Medical Ltd.:

Primary Outcome Measures:
  • frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without. [ Time Frame: safety will be assesed after 6 months at the study completion ] [ Designated as safety issue: Yes ]

    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. [ Time Frame: safety will be assesed after 6 months at the study completion ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: safety will be assesed after 6 months at the study completion ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 147
Study Start Date: February 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test
InsuPatch use for 3 months.
Device: InsuPatch
Heaters for single use and a permanent control unit.
No Intervention: Control

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283425

Locations
United States, California
Mills-Peninsula Health Services
San Mateo, California, United States, 94401
Israel
Soroka Medical Center
Beer Sheva, 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
Sponsors and Collaborators
Insuline Medical Ltd.
Push-Med LLC.
Investigators
Principal Investigator: Wainstein Julio, MD Wolfsom Medical Center, Holon, Israel
Principal Investigator: Itamar Raz, MD Hadassah Medical Organization
Principal Investigator: Klonoff David, MD Mills Peninsula Health Services
Principal Investigator: Naim Shhada, MD Rambam Health Care Campus
Principal Investigator: Orit Hamiel, MD Sheba Medical Center
Principal Investigator: Moshe Philips, MD Schnieder Children's Medical Center
Principal Investigator: Anat Yaffe, Md Hiullel Yaffe Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Insuline Medical Ltd.
ClinicalTrials.gov Identifier: NCT01283425     History of Changes
Other Study ID Numbers: G080106/B
Study First Received: January 19, 2011
Last Updated: May 13, 2012
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

Keywords provided by Insuline Medical Ltd.:
MiniMed Paradigm insulin pump
insulin Lispro
Insulin Aspart
Quick-set infusion set

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014