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

NCT03566693 | Completed FDA Device

• 1 other identifier: PTL-902822
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 15

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).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Phase 1: Change in CGM time in target range

  Baseline to Month 8

• Phase 1: Change in CGM time-hyperglycemic

  Baseline to Month 8

• Phase 1: Change in mean glucose from CGM

  Baseline to Month 8

• Phase 1: Percent decreasing HbA1c by ≥0.5%

  Baseline to Month 8

• Phase 1: Proportion increasing CGM time in target range by ≥10% and ≥15%

  Baseline to Month 8

Other Outcomes (37)

• Phase 1 and Phase 2: Percent with glycated hemoglobin <7.0%

  Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

• Phase 1 and Phase 2:Percent with glycated hemoglobin <7.5%

  Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

• Percent decreasing glycated hemoglobin by ≥1.0% (absolute)

  Baseline to Month 8, Baseline to Month 14

Study Arms (2)

Continous Glucose Monitor

EXPERIMENTAL

Device: Dexcom G6 CGM System

Self Monitoring Blood Glucose

ACTIVE COMPARATOR

Device: Blood glucose meter

Interventions

Dexcom G6 CGM System DEVICE

continuous glucose monitor

Continous Glucose Monitor

Blood glucose meter DEVICE

Blue-tooth enabled blood glucose meter

Self Monitoring Blood Glucose

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Renal disease
• Conditions that impact the stability of a HbA1c measurement
• Use of prandial insulin

Sponsors & Collaborators

• DexCom, Inc.: lead
• Jaeb Center for Health Research: collaborator

Study Sites (15)

Keck School of Medicine @ USC

Los Angeles, California, 90022, United States

Location

Scripps Whittier Diabetes Institute

San Diego, California, 92121, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Northwestern Memorial

Chicago, Illinois, 60611, United States

Location

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, 50265, United States

Location

University of Michigan Internal Medicine

Ann Arbor, Michigan, 48105, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Park Nicollet International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Washington University Barnes Jewish Hospital

St Louis, Missouri, 63130, United States

Location

Las Vegas Endocrinology

Henderson, Nevada, 89052, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27517, United States

Location

Carteret Medical Group

Morehead City, North Carolina, 28557, United States

Location

Lucas Research / Diabetes & Endocrinology Consultants, PC

Morehead City, North Carolina, 28557, United States

Location

Vanderbilt Eskind Diabetes Clinic

Nashville, Tennessee, 37212, United States

Location

Amarillo Medical Specialists, LLP

Amarillo, Texas, 79106, United States

Location

Related Publications (5)

• Martens TW, Beck RW, Griffen C, Di J, Elkind-Hirsch K, Johnson ML, Castle JR, Beck SE, Bergenstal RM. Rapid improvements in glycemic management with use of continuous glucose monitoring in adults with type 2 diabetes treated with basal insulin: 3-month analysis of the MOBILE study. BMJ Open Diabetes Res Care. 2025 Nov 4;13(6):e005469. doi: 10.1136/bmjdrc-2025-005469.

  PMID: 41192933 DERIVED

• Davis G, Bailey R, Calhoun P, Price D, Beck RW. Magnitude of Glycemic Improvement in Patients with Type 2 Diabetes Treated with Basal Insulin: Subgroup Analyses from the MOBILE Study. Diabetes Technol Ther. 2022 May;24(5):324-331. doi: 10.1089/dia.2021.0489. Epub 2022 Apr 26.

  PMID: 34962151 DERIVED

• Bailey R, Calhoun P, Chao C, Walker TC. With or Without Residual C-Peptide, Patients with Type 2 Diabetes Realize Glycemic Benefits from Real-Time Continuous Glucose Monitoring. Diabetes Technol Ther. 2022 Apr;24(4):281-284. doi: 10.1089/dia.2021.0384. Epub 2022 Mar 21.

  PMID: 34704817 DERIVED

• Aleppo G, Beck RW, Bailey R, Ruedy KJ, Calhoun P, Peters AL, Pop-Busui R, Philis-Tsimikas A, Bao S, Umpierrez G, Davis G, Kruger D, Bhargava A, Young L, Buse JB, McGill JB, Martens T, Nguyen QT, Orozco I, Biggs W, Lucas KJ, Polonsky WH, Price D, Bergenstal RM; MOBILE Study Group; Type 2 Diabetes Basal Insulin Users: The Mobile Study (MOBILE) Study Group:. The Effect of Discontinuing Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin. Diabetes Care. 2021 Dec;44(12):2729-2737. doi: 10.2337/dc21-1304. Epub 2021 Sep 29.

  PMID: 34588210 DERIVED

• Martens T, Beck RW, Bailey R, Ruedy KJ, Calhoun P, Peters AL, Pop-Busui R, Philis-Tsimikas A, Bao S, Umpierrez G, Davis G, Kruger D, Bhargava A, Young L, McGill JB, Aleppo G, Nguyen QT, Orozco I, Biggs W, Lucas KJ, Polonsky WH, Buse JB, Price D, Bergenstal RM; MOBILE Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial. JAMA. 2021 Jun 8;325(22):2262-2272. doi: 10.1001/jama.2021.7444.

  PMID: 34077499 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David Price, MD

  DexCom, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 25, 2018
• Study Start: July 30, 2018
• Primary Completion: January 4, 2021
• Study Completion: January 4, 2021
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)