Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Dexcom G6 CGM System
* Device: Blood glucose meter


Participation Criteria
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Eligibility Criteria
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Major Inclusion Criteria: 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 Exclusion Criteria: Pregnancy Renal disease Conditions that impact the stability of a HbA1c measurement Use of prandial insulin

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continous Glucose Monitor<br> | Device: Dexcom G6 CGM System<br>* continuous glucose monitor<br>|
| Active Comparator: Self Monitoring Blood Glucose<br> | Device: Blood glucose meter<br>* Blue-tooth enabled blood glucose meter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Change in HbA1c | Phase 1: Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to Month 8 | Baseline to Month 8 | 
| Phase 2: Change in CGM time in target range | 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 | Month 8 to Month 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1: Change in CGM time in target range | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time in target range 70-180 mg/dL | Baseline to Month 8 | 
| Phase 1: Change in CGM time-hyperglycemic | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hyperglycemic, defined as >250 mg/dL | Baseline to Month 8 | 
| Phase 1: Change in mean glucose from CGM | Between group differences (CGM and SMBG) from baseline to Month 8 of change in mean glucose from CGM | Baseline to Month 8 | 
| Phase 1: Percent decreasing HbA1c by ≥0.5% | Between group differences (CGM and SMBG) from baseline to Month 8 of percent decreasing HbA1c by ≥0.5% (absolute) | Baseline to Month 8 | 
| Phase 1: Proportion increasing CGM time in target range by ≥10% and ≥15% | Between group differences (CGM and SMBG) from baseline to Month 8 of proportion increasing CGM time in target range by ≥10% and ≥15% (absolute) | Baseline to Month 8 | 
| Phase 1: Percent adding or removing diabetes medications | Between group differences (CGM and SMBG) from baseline to Month 8 of percent adding or removing diabetes medications (starting or stopping medications) | Baseline to Month 8 | 
| Phase 1: Change in HbA1c based on their baseline HbA1c | 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%) | Baseline to Month 8 | 
| Phase 1: Change in CGM glucose variability | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM glucose variability measured by the coefficient of variation | Baseline to Month 8 | 
| Phase 1: Change in CGM time-hypoglycemic | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hypoglycemic, defined as <70mg/dL | Baseline to Month 8 | 
| Phase 2: Change in HbA1c | 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) | Month 8 to Month 14 & Baseline to Month 14 | 
| Phase 2: Change in CGM time-hyperglycemic | Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hyperglycemic, defined as >250 mg/dL | Month 8 to Month 14 & Baseline to Month 14 | 
| Phase 2: Percent decreasing HbA1c by ≥0.5% | 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) | Month 8 to Month 14 & Baseline to Month 14 | 
| Phase 2: Proportion increasing CGM time in target range by ≥10% and ≥15% | 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 proportion increasing | 
| Phase 2: Percent adding or removing diabetes medications | 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) | Month 8 to Month 14 & Baseline to Month 14 | 
| Phase 2: Change in CGM glucose variability | 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 | Month 8 to Month 14 & Baseline to Month 14 | 
| Phase 2: Change in CGM time-hypoglycemic | 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 | Month 8 to Month 14 & Baseline to Month 14 |