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Pediatric Diabetics Type 1 Using InsuPatch

This study has been completed.
Sponsor:
Collaborator:
Push-Med LLC.
Information provided by (Responsible Party):
Insuline Medical Ltd.
ClinicalTrials.gov Identifier:
NCT01368978
First received: December 21, 2010
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Type 1 Diabetes Mellitus
 Device: InsuPatch
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Insuline Medical Ltd.:

Primary Outcome Measures:
  • Efficacy [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: December 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Device: InsuPatch
device which apply local heating at 38.5 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site.
Experimental: Test Device: InsuPatch
device which apply local heating at 38.5 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site.

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368978

Locations
United States, Connecticut
Yale University
New Haven, Connecticut, United States
Sponsors and Collaborators
Insuline Medical Ltd.
Push-Med LLC.
Investigators
Principal Investigator: Eda Cengiz, MD Yale University
  More Information

No publications provided

Responsible Party: Insuline Medical Ltd.
ClinicalTrials.gov Identifier: NCT01368978     History of Changes
Other Study ID Numbers: G090175
Study First Received: December 21, 2010
Last Updated: May 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Insuline Medical Ltd.:
TIDM

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

ClinicalTrials.gov processed this record on May 19, 2013