Pediatric Diabetics Type 1 Using InsuPatch

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Evaluation of the Effect of lnsuPatch on the Pharmacokinetic and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs Given as a Bolus by Continuous Subcutaneous Insulin Infusion (CSII)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01368978
• Other study ID #: G090175
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2010
• Last updated: September 4, 2014
• Start date: December 2009
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Insuline Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Insuline Medical Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy	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.	one year	No