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Comparison of 3 Versus 6-Month Use of CGMS in Non-Insulin Using T2DM Patients

Primary Purpose

T2DM (Type 2 Diabetes Mellitus), Continuous Glucose Monitoring

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iPro2 Professional CGM
Sponsored by
East Tennessee State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for T2DM (Type 2 Diabetes Mellitus)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years or older with a diagnosis of T2DM with a scheduled office visit with primary care provider within the next 4 weeks
  2. Last 2 HbA1c values between 7.5 - 10% measured in the last 12 months
  3. Treated with non-insulin therapies or therapeutic lifestyle changes
  4. Never worn professional CGM or have not worn in last 12 months
  5. Willing to perform requirements needed for professional CGM

Exclusion Criteria:

1. Current or previous treatment with any insulin within 3 months at baseline

Sites / Locations

  • East Tennessee State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3-Month iPro2 Professional CGM

6-Month iPro2 Professional CGM

Arm Description

Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.

Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.

Outcomes

Primary Outcome Measures

Time Spent in Target Range
Time sensor glucose is between 70-140mg/dl during a 72 hour collection period

Secondary Outcome Measures

Full Information

First Posted
February 24, 2017
Last Updated
July 21, 2020
Sponsor
East Tennessee State University
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT03067480
Brief Title
Comparison of 3 Versus 6-Month Use of CGMS in Non-Insulin Using T2DM Patients
Official Title
Comparison of 3 Versus 6-Month Use of Professional Continuous Glucose Monitoring in the Treatment of Poorly Controlled, Non-Insulin Using T2DM Patients in a Primary Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
East Tennessee State University
Collaborators
Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
To determine whether 3-month versus 6-month professional CGM utilization improves time spent in target range of 70-140mg/dl in patients with poorly controlled T2DM not treated with insulin.
Detailed Description
Patients not receiving any insulin treatment with an HbA1c ≥ 7.5% before their scheduled primary care appointment will be invited to participate in the study and wear professional CGM for at least 3 days at either 3 intervals (baseline, 3-month and 6-month) or 2 intervals (baseline and 6-month). After removal, the downloaded report will provide quantitative data to determine the percent of time spent in the target range. The 6-month data will be analyzed to determine if frequency of professional CGM wear positively affects time spent in target range.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T2DM (Type 2 Diabetes Mellitus), Continuous Glucose Monitoring

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3-Month iPro2 Professional CGM
Arm Type
Experimental
Arm Description
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
Arm Title
6-Month iPro2 Professional CGM
Arm Type
Experimental
Arm Description
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
Intervention Type
Device
Intervention Name(s)
iPro2 Professional CGM
Intervention Description
Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
Primary Outcome Measure Information:
Title
Time Spent in Target Range
Description
Time sensor glucose is between 70-140mg/dl during a 72 hour collection period
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older with a diagnosis of T2DM with a scheduled office visit with primary care provider within the next 4 weeks Last 2 HbA1c values between 7.5 - 10% measured in the last 12 months Treated with non-insulin therapies or therapeutic lifestyle changes Never worn professional CGM or have not worn in last 12 months Willing to perform requirements needed for professional CGM Exclusion Criteria: 1. Current or previous treatment with any insulin within 3 months at baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rick Hess, PharmD
Organizational Affiliation
East Tennessee State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37614
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of 3 Versus 6-Month Use of CGMS in Non-Insulin Using T2DM Patients

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