Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?

Stopped early · Early Phase 1

Conditions studied: Type 1 Diabetes

In brief

This study will investigate the effect of wearing a small warming patch, the InsuPatch, at the site of the continuous glucose monitor (CGM), also called a sensor. Specifically, we will be looking to see if using the InsuPatch (IP) improves the accuracy of the continuous glucose monitor.

Key facts

Study ID

NCT01954459

Run by

Yale University

People needed

11

Starts

2013-09-01

Expected to finish

2016-06-01

Last updated by the study team

2020-03-09

Who can join

Age: 8 and older, up to 44. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least 12 months.
• Age 8 years to less than 45 years old.
• Subject understands the study protocol and agree to comply with it.
• Subject is on insulin pump or injection-based basal-bolus therapy
• Subject comprehends written English.
• For females, subject not intending to become pregnant during the study.
• Informed Consent Form signed by the subject
• No history of altered skin integrity, poor wound healing, adhesive allergy, or previous infection from sensor wear.
• Hemoglobin A1C ≤10%

You may not qualify if…

• The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
• The presence of any of the following diseases:
• a. Current use of systemic corticosteroids (within the last week) b. Other major illness that in the judgment of the investigator might interfere with the completion of the protocol i. Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
• Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
• Current or past use of a continuous glucose sensor is not an exclusion criterion.
• Active skin condition that would affect sensor placement
• Use of acetaminophen or Vitamin C supplement within the last 7 days
• Subject is deemed by the Investigator to be unwilling or unable to follow the protocol;
• Pregnancy A negative urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study.

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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