Continuous Glucose Monitoring, T2DM (Type 2 Diabetes Mellitus)
Conditions
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.
Interventions
DEVICEiPro2 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.
Sponsors
Medtronic
East Tennessee State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Spent in Target Range | 6 Months | Time sensor glucose is between 70-140mg/dl during a 72 hour collection period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 3-Month 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.
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. | 5 |
| 6-Month 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.
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. | 7 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 4 |
| Overall Study | started insulin | 1 | 1 |
Baseline characteristics
| Characteristic | Total | 6-Month iPro2 Professional CGM | 3-Month iPro2 Professional CGM |
|---|---|---|---|
| A1c | 9.6 percent STANDARD_DEVIATION 1.4 | 9.6 percent STANDARD_DEVIATION 1.2 | 9.7 percent STANDARD_DEVIATION 1.6 |
| Age, Continuous | 57.1 years STANDARD_DEVIATION 7.4 | 54.0 years STANDARD_DEVIATION 7.3 | 61.4 years STANDARD_DEVIATION 4.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 4 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 7 |
| other Total, other adverse events | 0 / 5 | 0 / 7 |
| serious Total, serious adverse events | 0 / 5 | 0 / 7 |
Outcome results
Primary
Time Spent in Target Range
Time sensor glucose is between 70-140mg/dl during a 72 hour collection period
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3-Month iPro2 Professional CGM | Time Spent in Target Range | 38.5 percentage | Standard Deviation 18.5 |
| 6-Month iPro2 Professional CGM | Time Spent in Target Range | 50 percentage | Standard Deviation 40 |