Back to resultsPediatric Diabetics Type 1 Using InsuPatch
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
InsuPatch
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring TIDM
Eligibility Criteria
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)
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Test (with the InsuPatch device)
Control (without the InsuPatch device)
Arm Description
Device use
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01368978
First Posted
December 21, 2010
Last Updated
September 4, 2014
Sponsor
Insuline Medical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01368978
Brief Title
Pediatric Diabetics Type 1 Using InsuPatch
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 Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insuline Medical Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
TIDM
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test (with the InsuPatch device)
Arm Type
Experimental
Arm Description
Device use
Arm Title
Control (without the InsuPatch device)
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
InsuPatch
Intervention Description
device which apply local heating at 38.5 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site.
Primary Outcome Measure Information:
Title
Efficacy
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eda Cengiz, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pediatric Diabetics Type 1 Using InsuPatch
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