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

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT01283425

Run by

Insuline Medical Ltd.

People needed

147

Starts

2011-02-01

Expected to finish

2012-04-01

Last updated by the study team

2014-09-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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