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

NCT ID: NCT01954459

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-06-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Sensor alone

Glucose sensor site will not have Insupatch

Group Type: ACTIVE_COMPARATOR

Continuous glucose sensor

Intervention Type: DEVICE

Glucose sensor inserted without warming patch

Sensor with Insupatch

Glucose sensor site with Insupatch

Group Type: EXPERIMENTAL

Insupatch

Intervention Type: DEVICE

Device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous site of glucose sensor.

Interventions

Insupatch

Device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous site of glucose sensor.

Intervention Type: DEVICE

Continuous glucose sensor

Glucose sensor inserted without warming patch

Intervention Type: DEVICE

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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• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Camille Michaud, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

R01DK085618-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1306012208

Identifier Type: -

Identifier Source: org_study_id