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

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.

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.