Pediatric Diabetics Type 1 Using InsuPatch

NCT ID: NCT01368978

Last Updated: 2014-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-05-31

Brief Summary

This study is a prospective, single-center, open label, randomized; two-arms cross over study.

This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.

Detailed Description

Twenty(20) type 1 children with Type 1 Diabetics Mellitus (TIDM) who are meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.

The study will consist of an outpatient enrollment visit and two admissions(One clamps with the InsuPatch and one clamp without the InsuPatch) . Each Subject will thus serve as his/her own control.

Conditions

Type 1 Diabetes Mellitus

Study Design

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

Study Groups

Test (with the InsuPatch device)

Device use

Group Type: EXPERIMENTAL

InsuPatch

Intervention Type: DEVICE

device which apply local heating at 38.5 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site.

Control (without the InsuPatch device)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

InsuPatch

device which apply local heating at 38.5 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age 12-17 (inclusive)

2. Clinical diagnosis of T1DM at least one year's duration

3. On CSII therapy for at least three months

4. Hemoglobin A1c(HBA1C) values below 10% and above 6.5%

5. Minimum weight requirements of at least 37.9 Kg.

6. Ability to comprehend written and spoken English

7. Body Mass Index z-score below 90%

Exclusion Criteria

1. Celiac disease, gastroparesis, or other gastrointestinal disorder associated with alerted carbohydrate absorption or intestinal motility.

2. Medication besides insulin known to alter blood glucose, gastric motility, or intestinal carbohydrate absorption

3. Female subjects of reproductive potential who are pregnant or breast feeding

4. Inability to comprehend written and spoken English

5. Any other condition, which in the judgment of the investigators, would interfere with the subject's or parents' ability to provide informed consent or the investigator's ability to perform the study.

6. Hematocrit below 35 or serum potassium below 3.4 (confirmed by two samples)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insuline Medical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eda Cengiz, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

G090175

Identifier Type: -

Identifier Source: org_study_id