Pediatric Diabetics Type 1 Using InsuPatch

Phase 3

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: InsuPatch

• Registration Number: NCT01368978
• Lead Sponsor: Insuline Medical Ltd.

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.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-12-21
• Study First Submitted QC: 2011-06-07
• Study First Posted: 2011-06-08
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test (with the InsuPatch device)	InsuPatch	Device use

Primary Outcome Measures

Name	Time	Method
Efficacy	one year	Insulin will be taken during the clamp and will be measured for concentration.The concentration of insulin during the first hour will be compared between the two arms for efficacy.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States