Pediatric Diabetics Type 1 Using InsuPatch

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01368978

Enrollment

Registered

2011-06-08

Start date

2009-12-31

Completion date

2012-05-31

Last updated

2014-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

TIDM

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.

Interventions

DEVICEInsuPatch

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026