T2DM (Type 2 Diabetes Mellitus)NCT03067480
Comparison of 3 Versus 6-Month Use of CGMS in Non-Insulin Using T2DM Patients
A study testing iPro2 Professional CGM in people with T2DM (Type 2 Diabetes Mellitus) and Continuous Glucose Monitoring, run by East Tennessee State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus), Continuous Glucose Monitoring
- What is being tested?
- iPro2 Professional CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Current or previous treatment with any insulin within 3 months at baseline
Trial locations and contacts
1 site in 1 country.
United States1 site
East Tennessee State University
Johnson City, Tennessee, 37614
About this study
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
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.
Read the 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.
- Being tested
- iPro2 Professional CGM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPro2 Professional CGMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 3-Month iPro2 Professional CGM | Experimental | 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. Receives: Device: iPro2 Professional CGM |
| 6-Month iPro2 Professional CGM | Experimental | 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. Receives: Device: iPro2 Professional CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent in Target Range
Time sensor glucose is between 70-140mg/dl during a 72 hour collection period
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start6 Jun 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Tennessee State University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Rick Hess, PharmD, Principal investigator, East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067480
- Sponsor's protocol ID
- ETSU
- Status last verified
- Dec 2025
- First submitted
- 24 Feb 2017
- Last updated
- 9 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03067480
- Acronym / sponsor ID
- ETSU
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- East Tennessee State UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 1 Mar 2017 (actual)
- Results
- Posted 9 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-Month iPro2 Professional CGM | Experimental | Device: iPro2 Professional CGMProfessional 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 | Experimental | Device: iPro2 Professional CGMProfessional 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Current or previous treatment with any insulin within 3 months at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPro2 Professional CGMProfessional 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. | Device | 3-Month iPro2 Professional CGM, 6-Month iPro2 Professional CGM |
Primary outcome
Time Spent in Target Range
Time frame: 6 Months
Time sensor glucose is between 70-140mg/dl during a 72 hour collection period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rick Hess, PharmD principal investigator
East Tennessee State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPro2 Professional CGM in people with T2DM (Type 2 Diabetes Mellitus) and Continuous Glucose Monitoring, run by East Tennessee State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Spent in Target Range (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.