Clinical trial NCT01283425: Evaluation of the Safety Use of the InsuPatch Device in Daily Life Conditions
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Keywords: MiniMed Paradigm insulin pump
insulin Lispro
Insulin Aspart
Quick-set infusion set
Lead sponsor: Insuline Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2011-01-26
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: frequency of mild hypoglycemia events (Blood Glucose<60mg/dl) with InsuPatch and without.
timeFrame: safety will be assesed after 6 months at the study completion
Secondary outcomes:
measure: Frequency of hyperglycemic events (BG>300 mg/dl, Fasting BG>250 mg/dl) with InsuPatch and without.
timeFrame: safety will be assesed after 6 months at the study completion
measure: Adverse events (AE's) count with InsuPatch and without.
timeFrame: safety will be assesed after 6 months at the study completion
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Mills-Peninsula Health Services
state: California
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Hadera
country: Israel
facility: Hillel Yaffe
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Jerusalem
country: Israel
facility: Haddasah Medical Organization
city: Petah Tikva
country: Israel
facility: Schneider Children's hospital
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Wolfsom Medical Center, Holon, Israel
name: Wainstein Julio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Itamar Raz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mills Peninsula Health Services
name: Klonoff David, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Naim Shhada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Orit Hamiel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Schnieder Children's Medical Center
name: Moshe Philips, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hiullel Yaffe Medical Center
name: Anat Yaffe, Md
role: PRINCIPAL_INVESTIGATOR
References: