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

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.

Study Overview

• Status: Terminated
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Continuous glucose sensor; Device: Insupatch

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School Of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 44 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sensor alone; Glucose sensor site will not have Insupatch	Device: Continuous glucose sensor; Glucose sensor inserted without warming patch
Experimental: Sensor with Insupatch; Glucose sensor site with Insupatch	Device: Insupatch; Device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous site of glucose sensor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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, comparing sensor glucose readings and signal data to serum Yellow Springs Instrument (YSI) glucose measurements, with each subject acting as his or her own control.	4 hours after lunch, 8 hours after breakfast

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Camille Michaud, MD, Yale University

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 26, 2013
• First Submitted That Met QC Criteria: September 26, 2013
• First Posted (Estimate): October 1, 2013

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Type 1 diabetes; Continuous glucose sensor; Insupatch
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 1306012208; R01DK085618-01 (U.S. NIH Grant/Contract)