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

NCT01283425 | Completed Phase 4

• 1 other identifier: G080106/B
• Study Type: interventional
• Target: 147
• Locations: 2 countries
• Sites: 8

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  safety will be assesed after 6 months at the study completion

Secondary Outcomes (2)

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

  safety will be assesed after 6 months at the study completion

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

  safety will be assesed after 6 months at the study completion

Study Arms (2)

Test

EXPERIMENTAL

InsuPatch use for 3 months.

Device: InsuPatch

Control

NO INTERVENTION

Interventions

InsuPatch DEVICE

Heaters for single use and a permanent control unit.

Test

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).
• Hypoglycemia unawareness.
• 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.

Sponsors & Collaborators

• Insuline Medical Ltd.: lead

Study Sites (8)

Mills-Peninsula Health Services

San Mateo, California, 94401, United States

Location

Soroka Medical Center

Beersheba, Israel

Location

Hillel Yaffe

Hadera, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Wolfson Medical Center

Holon, Israel

Location

Haddasah Medical Organization

Jerusalem, Israel

Location

Schneider Children's hospital

Petah Tikva, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2011
• First Posted: January 26, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: September 4, 2014

Record last verified: 2012-04

Locations

US (1); IL (7)