Skip to main content
OpenTrials
Completed

NCT Number: NCT01368978

Pediatric Diabetics Type 1 Using InsuPatch

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yale University

New Haven, Connecticut, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 12-17 (inclusive)
  • Clinical diagnosis of T1DM at least one year's duration
  • On CSII therapy for at least three months
  • Hemoglobin A1c(HBA1C) values below 10% and above 6.5%
  • Minimum weight requirements of at least 37.9 Kg.
  • Ability to comprehend written and spoken English
  • Body Mass Index z-score below 90%

Exclusion criteria

  • Celiac disease, gastroparesis, or other gastrointestinal disorder associated with alerted carbohydrate absorption or intestinal motility.
  • Medication besides insulin known to alter blood glucose, gastric motility, or intestinal carbohydrate absorption
  • Female subjects of reproductive potential who are pregnant or breast feeding
  • Inability to comprehend written and spoken English
  • 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.
  • Hematocrit below 35 or serum potassium below 3.4 (confirmed by two samples)

Treatment and study plan

InsuPatch

Device

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

Primary outcomes

  1. Efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Insuline Medical Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 8, 2011
Registry last updated
Sep 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.