Study Stopped
Low enrollment
Comparison of 3 Versus 6-Month Use of CGMS in Non-Insulin Using T2DM Patients
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
February 24, 2017
CompletedFirst Posted
Study publicly available on registry
March 1, 2017
CompletedStudy Start
First participant enrolled
June 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedResults Posted
Study results publicly available
January 9, 2026
CompletedJanuary 9, 2026
December 1, 2025
2.3 years
February 24, 2017
December 13, 2022
December 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time Spent in Target Range
Time sensor glucose is between 70-140mg/dl during a 72 hour collection period
6 Months
Study Arms (2)
3-Month iPro2 Professional CGM
EXPERIMENTALProfessional 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.
6-Month iPro2 Professional CGM
EXPERIMENTALProfessional 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \. Current or previous treatment with any insulin within 3 months at baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniccollaborator
- East Tennessee State Universitylead
Study Sites (1)
East Tennessee State University
Johnson City, Tennessee, 37614, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rick Hess
- Organization
- East Tennessee State University
Study Officials
- PRINCIPAL INVESTIGATOR
Rick Hess, PharmD
East Tennessee State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2017
First Posted
March 1, 2017
Study Start
June 6, 2017
Primary Completion
September 30, 2019
Study Completion
September 30, 2019
Last Updated
January 9, 2026
Results First Posted
January 9, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share