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

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03067480
• Other study ID #: ETSU
• Status: Terminated
• Phase: N/A
• Start date: June 6, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2020
• Source: East Tennessee State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Continuous Glucose Monitoring
• Diabetes Mellitus, Type 2
• T2DM (Type 2 Diabetes Mellitus)

Intervention

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.

Locations

Country	Name	City	State
United States	East Tennessee State University	Johnson City	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
East Tennessee State University	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Spent in Target Range	Time sensor glucose is between 70-140mg/dl during a 72 hour collection period	6 Months