Clinical trial NCT01954459: Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?
Official title: Warming up to Sensors: Does Site Warming Improve Continuous Glucose Monitor Performance?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Type 1 Diabetes
Keywords: Type 1 diabetes
Continuous glucose sensor
Insupatch
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2013-10-01
Enrollment: 11
Sex: ALL
Minimum age (years): 8
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Hypotheses:

1. Warming of the skin and subcutaneous tissue with the InsuPatch device will improve the accuracy of a CGM as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
2. Warming of the skin and subcutaneous tissue with the InsuPatch device will reduce the lag time of the CGM, as compared to a CGM used alone when both are calibrated with a standard laboratory quality glucose measuring reference standard.
3. The combination of the InsuPatch device and a CGM will be well-tolerated and not cause skin irritation.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. 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
3. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian)
4. Current or past use of a continuous glucose sensor is not an exclusion criterion.
5. Active skin condition that would affect sensor placement
6. Use of acetaminophen or Vitamin C supplement within the last 7 days
7. Subject is deemed by the Investigator to be unwilling or unable to follow the protocol;
8. 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.

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Primary outcomes:
measure: Point accuracy of the continuous glucose monitor plus Insupatch (CGM+IP) by mean absolute relative difference (MARD) calculation of sensors with and without IP use.
timeFrame: 4 hours after lunch, 8 hours after breakfast
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Camille Michaud, MD
role: PRINCIPAL_INVESTIGATOR
References: