Pediatric Diabetics Type 1 Using InsuPatch

Completed · Phase 3

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT01368978

Run by

Insuline Medical Ltd.

People needed

27

Starts

2009-12-01

Expected to finish

2012-05-01

Last updated by the study team

2014-09-05

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Yale University — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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