Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Device: Dexcom G6 CGM SystemDevice: Blood glucose meter
- Registration Number
- NCT03566693
- Lead Sponsor
- DexCom, Inc.
- Brief Summary
A study to compare the glycemic and quality of life benefits of diabetes management using Dexcom G6 continuous glucose monitoring (CGM) or self-monitored blood glucose (SMBG) made by study participants and their primary care physicians. Decisions will be based on insights from real-time use and retrospective insights, determined during remote visits.
Participants will have type 2 diabetes and be using basal insulin (with or without oral medications and/or Glucagon-Like-Peptide-1 (GLP-1) analogue) and have an elevated Hemoglobin A1C (HbA1c).
- Detailed Description
The study is referred to as the "Continuous Glucose MOnitoring in T2D Basal InsuLin UsErs, also known as The MOBILE Study" and will assess potential benefits of using Continuous Glucose Monitoring (CGM) versus traditional Blood Glucose Monitoring (BGM) in people with Type 2 Diabetes using basal insulin with or without oral medications and who have an elevated HbA1c between 7.8 -11.5%. In this study, the investigator's role is largely advisory, providing insights and interpretations of the glucose data obtained from BGM or CGM devices and formally communicating medication recommendations to the participant and their treating community clinician. Participants will be recruited from outside of the investigator team's diabetes and endocrine practice.
The protocol comprises of 2 studies: the 1st study (also called Phase 1) will evaluate the values of CGM after eight months of use. The 2nd study (also called Phase 2) will evaluate if any glycemic benefits attained in study one are sustainable for an additional six months.
At the time of enrollment, participants will undergo a run-in period of blinded CGM for a duration of 10 days. Baseline Patient Report Outcome (PRO) tools and surveys will be administered at time of enrollment.
The study design includes two phases. During Phase 1, participants with T2D taking basal insulin will be randomized into two groups - CGM Group or SMBG Group. Phase 1 is of 8 months duration. The CGM group will comprise of 4 scheduled clinic visits: at week 2, month 1, month 3, and month 8. The SMBG group will comprise of 5 scheduled clinic visits: at week 2, month 1, month 3, pre-month 8 and month 8. Both groups will have structured phone/remote visits at months 2, 4 and 6 during which glucose data will be reviewed and summarized. HbA1c will be measured at baseline, 3 months and 8 months. Participants will complete PRO tools and surveys at 8 months.
Phase 2 will consist of 3 groups: participants continuing use of SMBG since the beginning of Phase 1; participants re-randomized from the Phase 1 CGM Group and assigned to SMBG; participants re-randomized from Phase 1 CGM Group and assigned to CGM. Phase 2 duration is 6 months. This phase involves 1 phone contact and either 2 visits at Month 14 for SMBG participants to wear blinded CGM or one visit for CGM participants. HbA1c will be measured at 14 months. Participants will complete PRO tools and surveys at month 14. For all participants, study participation will end upon completion of month 14 visit .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
- Age 30 or older
- Diagnosis of Type 2 diabetes
- HbA1c between 7.8-11.5%
- Use of basal insulin, with or without concomitant use of oral agents or GLP-1 agonist
Major
- Pregnancy
- Renal disease
- Conditions that impact the stability of a HbA1c measurement
- Use of prandial insulin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continous Glucose Monitor Dexcom G6 CGM System - Self Monitoring Blood Glucose Blood glucose meter -
- Primary Outcome Measures
Name Time Method Phase 1: Change in HbA1c Baseline to Month 8 Phase 1: Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to Month 8
Phase 2: Change in CGM time in target range Month 8 to Month 14 Between group differences for the Phase 1 CGM Group re-randomized to Discontinue CGM (use SMBG only) or to Continue CGM for the change in time in target range (70-180 mg/dL) from Month 8 to Month 14
- Secondary Outcome Measures
Name Time Method Phase 1: Percent adding or removing diabetes medications Baseline to Month 8 Between group differences (CGM and SMBG) from baseline to Month 8 of percent adding or removing diabetes medications (starting or stopping medications)
Phase 2: Change in HbA1c Month 8 to Month 14 & Baseline to Month 14 Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of change in HbA1c (central lab)
Phase 1: Change in CGM time in target range Baseline to Month 8 Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time in target range 70-180 mg/dL
Phase 1: Change in mean glucose from CGM Baseline to Month 8 Between group differences (CGM and SMBG) from baseline to Month 8 of change in mean glucose from CGM
Phase 1: Change in CGM time-hypoglycemic Baseline to Month 8 Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hypoglycemic, defined as \<70mg/dL
Phase 2: Percent decreasing HbA1c by ≥0.5% Month 8 to Month 14 & Baseline to Month 14 Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of percent decreasing HbA1c by ≥0.5% (absolute)
Phase 2: Change in CGM glucose variability Month 8 to Month 14 & Baseline to Month 14 Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of change in CGM glucose variability measured by the coefficient of variation
Phase 1: Percent decreasing HbA1c by ≥0.5% Baseline to Month 8 Between group differences (CGM and SMBG) from baseline to Month 8 of percent decreasing HbA1c by ≥0.5% (absolute)
Phase 1: Change in CGM glucose variability Baseline to Month 8 Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM glucose variability measured by the coefficient of variation
Phase 2: Percent adding or removing diabetes medications Month 8 to Month 14 & Baseline to Month 14 Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of percent adding or removing diabetes medications (starting or stopping medication)
Phase 2: Change in CGM time-hypoglycemic Month 8 to Month 14 & Baseline to Month 14 Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of change in CGM time-hypoglycemic, defined as \<70mg/dL
Phase 1: Change in CGM time-hyperglycemic Baseline to Month 8 Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hyperglycemic, defined as \>250 mg/dL
Phase 1: Proportion increasing CGM time in target range by ≥10% and ≥15% Baseline to Month 8 Between group differences (CGM and SMBG) from baseline to Month 8 of proportion increasing CGM time in target range by ≥10% and ≥15% (absolute)
Phase 1: Change in HbA1c based on their baseline HbA1c Baseline to Month 8 Between group differences (CGM and SMBG) from baseline to Month 8 of change in HbA1c based on their baseline HbA1c (restricted to participants with baseline HbA1c ≥8.5%,≥9.0%, ≥9.5%, ≥10.0%)
Phase 2: Change in CGM time-hyperglycemic Month 8 to Month 14 & Baseline to Month 14 Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hyperglycemic, defined as \>250 mg/dL
Phase 2: Proportion increasing CGM time in target range by ≥10% and ≥15% Between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM group from Month 8 to Month 14 and between group differences for the Continue CGM and the Continue SMBG groups from baseline to Month 14 of proportion increasing Month 8 to Month 14 \& Baseline to Month 14
Trial Locations
- Locations (15)
Keck School of Medicine @ USC
🇺🇸Los Angeles, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Park Nicollet International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Amarillo Medical Specialists, LLP
🇺🇸Amarillo, Texas, United States
University of Michigan Internal Medicine
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Medical Center
🇺🇸Detroit, Michigan, United States
Scripps Whittier Diabetes Institute
🇺🇸San Diego, California, United States
Washington University Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Northwestern Memorial
🇺🇸Chicago, Illinois, United States
Iowa Diabetes and Endocrinology Research Center
🇺🇸West Des Moines, Iowa, United States
Lucas Research / Diabetes & Endocrinology Consultants, PC
🇺🇸Morehead City, North Carolina, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
Las Vegas Endocrinology
🇺🇸Henderson, Nevada, United States
Vanderbilt Eskind Diabetes Clinic
🇺🇸Nashville, Tennessee, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States