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Continuous Glucose Monitoring in T2D Basal Insulin Users: The MOBILE Study

University of North Carolina at Chapel Hill


Description

The primary purpose of this research is to assess the benefit on glycemic control, using real time continuous glucose (CGM) versus self monitored blood glucose (SMBG/finger sticks), in persons with Type 2 Diabetes (T2D) taking basal insulin (long-acting) with or without oral medications and/or GLP-1 analogue, not at their HbA1c goal. Secondary objectives are to assess quality of life benefits of RT-CGM and to assess frequency of hypoglycemia. The Phase 2 primary objective is to determine if glycemic control worsens upon withdrawal of RT-CGM. Secondary objectives are to determine if glycemic benefits of RT-CGM use are sustainable for a long period of time (14 months), to assess QoL benefits of continuing or discontinuing RT-CGM, and to assess frequency of hypoglycemia.


Keywords:

Diabetes


Category:

Device

Qualifications

 


Age
18 - 99 years


Gender
Any


Study Population

Adult T2D patients followed by a primary care physician, who are currently on basal insulin therapy with or without oral anti-diabetic therapy and/or GLP-1 analogue injections and who are sub-optimally controlled. Participants will be recruited from within the network or the referral base of the research site.


Investigator

Laura Young
Clinical Associate Professor
Medicine-Endocrinology

For questions, contact:

Alex Kass
alex_kass@med.unc.edu
(984) 974-3009


Recruitment Period End

October 1, 2019

Location

Primary Location
UNC Diabetes Care Center
Meadowmont Village Cir, Chapel Hill, NC 27517, USA

Study Qualifications

Gender Any

Age Range 18 - 99 years

Participant qualification(s) Have type 2 diabetes Have a Hemoglobin A1c between 7.8% and 11.5% Have your diabetes managed by your primary care provider and do NOT see an endocrinologist (diabetes specialist) Use 1-2 injections of basal (long acting) or intermediate acting insulin daily Long acting insulin common brands: Tresiba, Lantus, Levemir, Basaglar, NPH

Not eligible if: Do NOT use bolus (short acting or meal time) insulin Short acting insulin common brands: Novolog, Humalog, Apidra, FiAsp, Regular Insulin (R) Have never used a CGM for real-time diabetes management before

Number of Visits

    » 6 or 7 In person visit(s)

    1 screening, 5 clinic visits, (1 CGM placement visit for SMBG group)

    » 4 Remote visit(s)

    4 phone

Participation Period

16 weeks

Compensation

~$25 per phone visits and ~$50 per clinic visit

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.