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Trial record 1 of 1 for:    03566693
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Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE) (MOBILE)

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ClinicalTrials.gov Identifier: NCT03566693
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
Jaeb Center for Health Research
Information provided by (Responsible Party):
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).


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 8.0-11.5%. 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 .


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 207 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 : May 31, 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: CGM Device: Dexcom G6 CGM System
continuous glucose monitor

Active Comparator: SMBG Device: Blood glucose meter
Blue-tooth enabled blood glucose meter




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 8.0-11.5%
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566693


Contacts
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Contact: Paul Genge 858-203-6096 paul.genge@dexcom.com

Locations
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United States, California
Keck School of Medicine @ USC Recruiting
Los Angeles, California, United States, 90022
Contact: Martha Walker, MA, RD, CDE       mawalker@usc.edu   
Principal Investigator: Anne Peters, M.D.         
Scripps Whittier Diabetes Institute Recruiting
San Diego, California, United States, 92121
Contact: Cherri Rosario       Rosal.Rosario@scrippshealth.org   
Principal Investigator: Athena Philis-Tsimikas, M.D.         
United States, Georgia
Atlanta Diabetes Associates Withdrawn
Atlanta, Georgia, United States, 30318
United States, Idaho
Rocky Mountain Diabetes & Osteoporosis Center, P.A. Withdrawn
Idaho Falls, Idaho, United States, 83404-7596
United States, Illinois
Northwestern Memorial Recruiting
Chicago, Illinois, United States, 60611
Contact: Anupam Bansal       anupam.bansal@northwestern.edu   
Principal Investigator: Grazia Aleppo, M.D.         
United States, Iowa
Iowa Diabetes and Endocrinology Research Center Recruiting
West Des Moines, Iowa, United States, 50265
Contact: Kristie Stifel    515-329-6804    kstifel@iderc.com   
Principal Investigator: Anuj Bhargava, M.D.         
United States, Maryland
MODEL Clinical Research Withdrawn
Baltimore, Maryland, United States, 21204
United States, Michigan
University of Michigan Internal Medicine Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Cindy Plunkett       cplunket@med.umich.edu   
Principal Investigator: Rodica Pop-Busui, M.D.,Ph.D.         
Henry Ford Medical Center Recruiting
Detroit, Michigan, United States, 48202
Contact: Terra Cushman       TCUSHMA1@hfhs.org   
Principal Investigator: Davida F Kruger, MSN, APRN-BC         
United States, Minnesota
Park Nicollet International Diabetes Center Recruiting
Minneapolis, Minnesota, United States, 55416
Contact: Kathy McCann    952-993-3705    Kathleen.mccann@parknicollet.com   
Principal Investigator: Thomas Martens, M.D.         
United States, Missouri
Washington University Barnes Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Carol Recklein       crecklei@wustl.edu   
Principal Investigator: Janet McGill, M.D.         
United States, Nevada
Las Vegas Endocrinology Recruiting
Henderson, Nevada, United States, 89052
Contact: Alejandra Martinez       zillah725@gmail.com   
Principal Investigator: Quang Nguyen, D.O.         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Alex Kass, BSN, RN, CDE    984-974-3009    alex_kass@med.unc.edu   
Principal Investigator: Laura Young, M.D.,Ph.D.         
United States, Tennessee
Vanderbilt Eskind Diabetes Clinic Recruiting
Nashville, Tennessee, United States, 37212
Contact: Dianne Davis       Dianne.Davis@vumc.org   
Principal Investigator: Shichun Bao, M.D.,Ph.D.         
United States, Texas
Amarillo Medical Specialists, LLP Recruiting
Amarillo, Texas, United States, 79106
Contact: Becky Cota       Becky.Cota@amarillomed.com   
Principal Investigator: William C Biggs, MD,FACE         
Texas Diabetes & Endocrinology, P.A. Withdrawn
Austin, Texas, United States, 78731
Texas Diabetes & Endocrinology, P.A. Terminated
Austin, Texas, United States, 78749
Research Institute of Dallas Withdrawn
Dallas, Texas, United States, 75231
United States, Utah
Advanced Research Institute Withdrawn
Ogden, Utah, United States, 84405
Sponsors and Collaborators
DexCom, Inc.
Jaeb Center for Health Research
Investigators
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Study Director: David Price, MD DexCom, Inc.

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Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT03566693     History of Changes
Other Study ID Numbers: PTL-902822
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs