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

East Tennessee State University

Status: Terminated

Conditions: Continuous Glucose Monitoring; T2DM (Type 2 Diabetes Mellitus)

Treatments: Device: iPro2 Professional CGM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03067480

ETSU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

3-Month iPro2 Professional CGM

Experimental group

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.

Treatment:

Device: iPro2 Professional CGM

6-Month iPro2 Professional CGM

Experimental group

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.

Treatment:

Device: iPro2 Professional CGM