An interventional study of iPro2 Professional CGM in T2DM (Type 2 Diabetes Mellitus) and Continuous Glucose Monitoring, sponsored by East Tennessee State University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by East Tennessee State University · Not applicable, Interventional, and Supportive care
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.
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 12 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →East Tennessee State University is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1. Current or previous treatment with any insulin within 3 months at baseline
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: iPro2 Professional CGM
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.
Device: iPro2 Professional CGM
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.
Time Spent in Target Range
Time sensor glucose is between 70-140mg/dl during a 72 hour collection period
Time frame: 6 Months
| Milestone | 3-Month iPro2 Professional CGM | 6-Month iPro2 Professional CGM |
|---|---|---|
| Started | 5 | 7 |
| Completed | 2 | 2 |
| Not completed | 3 | 5 |
| Withdrew: Lost to follow-up | 2 | 4 |
| Withdrew: Started insulin | 1 | 1 |
Time sensor glucose is between 70-140mg/dl during a 72 hour collection period
| percentage | 3-Month iPro2 Professional CGM | 6-Month iPro2 Professional CGM |
|---|---|---|
| Time Spent in Target Range | 38.5 ± 18.5 | 50 ± 40 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 3-Month iPro2 Professional CGM | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| 6-Month iPro2 Professional CGM | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | 3-Month iPro2 Professional CGM | 6-Month iPro2 Professional CGM | Total |
|---|---|---|---|
| Mean | 61.4 ± 4.8 | 54.0 ± 7.3 | 57.1 ± 7.4 |
| Sex: Female, Male(Participants) | 3-Month iPro2 Professional CGM | 6-Month iPro2 Professional CGM | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 3 | 4 | 7 |
| Race (NIH/OMB)(Participants) | 3-Month iPro2 Professional CGM | 6-Month iPro2 Professional CGM | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 4 | 7 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| A1c(percent) | 3-Month iPro2 Professional CGM | 6-Month iPro2 Professional CGM | Total |
|---|---|---|---|
| Mean | 9.7 ± 1.6 | 9.6 ± 1.2 | 9.6 ± 1.4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2017 to primary completion in Sep 2019, 27 months.
Results were first posted in Jan 2026, 6 years 3 months after primary completion.
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This study is terminated, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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East Tennessee State University