NCT01954459

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Sep 2013

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

September 26, 2013

Last Update Submit

March 4, 2020

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesContinuous glucose sensorInsupatch

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Sensor alone

ACTIVE COMPARATOR

Glucose sensor site will not have Insupatch

Device: Continuous glucose sensor

Sensor with Insupatch

EXPERIMENTAL

Glucose sensor site with Insupatch

Device: Insupatch

Interventions

InsupatchDEVICE

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

Sensor with Insupatch
Continuous glucose sensorDEVICE

Glucose sensor inserted without warming patch

Sensor alone

Eligibility Criteria

Age8 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Camille Michaud, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2013

First Posted

October 1, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

March 9, 2020

Record last verified: 2020-03

Locations

US(1)