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

NCT ID: NCT03566693

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-30
• Study Completion Date: 2021-01-04

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 .

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Continous Glucose Monitor

Group Type: EXPERIMENTAL

Dexcom G6 CGM System

Intervention Type: DEVICE

continuous glucose monitor

Self Monitoring Blood Glucose

Group Type: ACTIVE_COMPARATOR

Blood glucose meter

Intervention Type: DEVICE

Blue-tooth enabled blood glucose meter

Interventions

Dexcom G6 CGM System

continuous glucose monitor

Intervention Type: DEVICE

Blood glucose meter

Blue-tooth enabled blood glucose meter

Intervention Type: DEVICE

Eligibility Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaeb Center for Health Research

OTHER

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Price, MD

Role: STUDY_DIRECTOR

DexCom, Inc.

Locations

Keck School of Medicine @ USC

Los Angeles, California, United States

Scripps Whittier Diabetes Institute

San Diego, California, United States

Emory University

Atlanta, Georgia, United States

Northwestern Memorial

Chicago, Illinois, United States

Iowa Diabetes and Endocrinology Research Center

West Des Moines, Iowa, United States

University of Michigan Internal Medicine

Ann Arbor, Michigan, United States

Henry Ford Medical Center

Detroit, Michigan, United States

Park Nicollet International Diabetes Center

Minneapolis, Minnesota, United States

Washington University Barnes Jewish Hospital

St Louis, Missouri, United States

Las Vegas Endocrinology

Henderson, Nevada, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Carteret Medical Group

Morehead City, North Carolina, United States

Lucas Research / Diabetes & Endocrinology Consultants, PC

Morehead City, North Carolina, United States

Vanderbilt Eskind Diabetes Clinic

Nashville, Tennessee, United States

Amarillo Medical Specialists, LLP

Amarillo, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34962151 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34704817 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34588210 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34077499 (View on PubMed)

Other Identifiers

PTL-902822

Identifier Type: -

Identifier Source: org_study_id