Pediatric Diabetics Type 1 Using InsuPatch

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01368978
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : September 5, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: InsuPatch Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : December 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Test (with the InsuPatch device)
Device use
Device: InsuPatch
device which apply local heating at 38.5 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site.

No Intervention: Control (without the InsuPatch device)

Primary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01368978

United States, Connecticut
Yale University
New Haven, Connecticut, United States
Sponsors and Collaborators
Insuline Medical Ltd.
Principal Investigator: Eda Cengiz, MD Yale University

Responsible Party: Insuline Medical Ltd. Identifier: NCT01368978     History of Changes
Other Study ID Numbers: G090175
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: May 2012

Keywords provided by Insuline Medical Ltd.:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases