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)
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 21, 2010
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedSeptember 5, 2014
May 1, 2012
2.4 years
December 21, 2010
September 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
one year
Study Arms (2)
Test (with the InsuPatch device)
EXPERIMENTALDevice use
Control (without the InsuPatch device)
NO INTERVENTIONInterventions
device which apply local heating at 38.5 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale University
New Haven, Connecticut, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eda Cengiz, MD
Yale University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2010
First Posted
June 8, 2011
Study Start
December 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
September 5, 2014
Record last verified: 2012-05