Recruitment

Recruitment Status
Terminated
Estimated Enrollment
20

Inclusion Criterias

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

Exclusion Criterias

Subject is deemed by the Investigator to be unwilling or unable to follow the protocol;
Use of acetaminophen or Vitamin C supplement within the last 7 days
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
...
Subject is deemed by the Investigator to be unwilling or unable to follow the protocol;
Use of acetaminophen or Vitamin C supplement within the last 7 days
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
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
Current or past use of a continuous glucose sensor is not an exclusion criterion.

Summary

Conditions
Type 1 Diabetes
Type
Interventional
Phase
Early Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Other

Participation Requirements

Age
Between 8 years and 44 years
Gender
Both males and females

Description

Hypotheses: 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. Warming of the skin and subcutaneous tissue with the ...

Hypotheses: 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. 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. The combination of the InsuPatch device and a CGM will be well-tolerated and not cause skin irritation.

Inclusion Criterias

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

Exclusion Criterias

Subject is deemed by the Investigator to be unwilling or unable to follow the protocol;
Use of acetaminophen or Vitamin C supplement within the last 7 days
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
...
Subject is deemed by the Investigator to be unwilling or unable to follow the protocol;
Use of acetaminophen or Vitamin C supplement within the last 7 days
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
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
Current or past use of a continuous glucose sensor is not an exclusion criterion.

Locations

New Haven, Connecticut, 06520
New Haven, Connecticut, 06520

Tracking Information

NCT #
NCT01954459
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
  • Principal Investigator: Camille Michaud, MD Yale University
  • Camille Michaud, MD Yale University