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

• ClinicalTrials.gov Identifier: NCT03566693
• Recruitment Status: Active, not recruiting
• First Posted: June 25, 2018
• Last Update Posted: June 11, 2020
• Sponsor: DexCom, Inc.
• Collaborator: Jaeb Center for Health Research
• Information provided by (Responsible Party): DexCom, Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Device: Dexcom G6 CGM System; Device: Blood glucose meter	Not Applicable

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 .

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)
• Actual Study Start Date: July 30, 2018
• Estimated Primary Completion Date: July 31, 2020
• Estimated Study Completion Date: January 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Continous Glucose Monitor	Device: Dexcom G6 CGM System; continuous glucose monitor
Active Comparator: Self Monitoring Blood Glucose	Device: Blood glucose meter; Blue-tooth enabled blood glucose meter

Outcome Measures

Primary Outcome Measures :

1. Phase 1: Change in HbA1c [ Time Frame: 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
2. Phase 2: Change in CGM time in target range [ Time Frame: 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 :

1. Phase 1: Change in CGM time in target range [ Time Frame: Baseline to Month 8 ]
   Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time in target rain 70-180 mg/dL
2. Phase 1: Percent decreasing HbA1c by ≥0.5% [ Time Frame: Baseline to Month 8 ]
   Between group differences (CGM and SMBG) from baseline to Month 8 of percent decreasing HbA1c by ≥0.5% (absolute)
3. Phase 1: Percent adding or removing diabetes medications [ Time Frame: 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)
4. Phase 1: Change in HbA1c based on their baseline HbA1c [ Time Frame: 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%)
5. Phase 1: Change in CGM time-hyperglycemic [ Time Frame: 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
6. Phase 1: Change in CGM glucose variability [ Time Frame: 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
7. Phase 1: Change in CGM time-hypoglycemic [ Time Frame: 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
8. Phase 2: Change in HbA1c [ Time Frame: 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)
9. Phase 2: Change in CGM time-hyperglycemic [ Time Frame: 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-hyperglycemic, defined as >250mg/dL
10. Phase 2: Percent decreasing HbA1c by ≥0.5% [ Time Frame: 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)
11. Phase 2: Percent adding or removing diabetes medications [ Time Frame: 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)
12. Phase 2: Change in CGM glucose variability [ Time Frame: 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
13. Phase 2: Change in CGM time-hypoglycemic [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 30 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Keck School of Medicine @ USC

Los Angeles, California, United States, 90022

Scripps Whittier Diabetes Institute

San Diego, California, United States, 92121

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30303

United States, Illinois

Northwestern Memorial

Chicago, Illinois, United States, 60611

United States, Iowa

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States, 50265

United States, Michigan

University of Michigan Internal Medicine

Ann Arbor, Michigan, United States, 48105

Henry Ford Medical Center

Detroit, Michigan, United States, 48202

United States, Minnesota

Park Nicollet International Diabetes Center

Minneapolis, Minnesota, United States, 55416

United States, Missouri

Washington University Barnes Jewish Hospital

Saint Louis, Missouri, United States, 63130

United States, Nevada

Las Vegas Endocrinology

Henderson, Nevada, United States, 89052

United States, North Carolina

University of North Carolina

Chapel Hill, North Carolina, United States, 27517

Carteret Medical Group

Morehead City, North Carolina, United States, 28557

Lucas Research / Diabetes & Endocrinology Consultants, PC

Morehead City, North Carolina, United States, 28557

United States, Tennessee

Vanderbilt Eskind Diabetes Clinic

Nashville, Tennessee, United States, 37212

United States, Texas

Amarillo Medical Specialists, LLP

Amarillo, Texas, United States, 79106

Sponsors and Collaborators

DexCom, Inc.

Jaeb Center for Health Research

Investigators

• Study Director: David Price, MD; DexCom, Inc.

More Information

• Responsible Party: DexCom, Inc.
• ClinicalTrials.gov Identifier: NCT03566693
• Other Study ID Numbers: PTL-902822
• First Posted: June 25, 2018
• Last Update Posted: June 11, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases