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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03566693
Recruitment Status : Active, not recruiting
First Posted : June 25, 2018
Last Update Posted : June 11, 2020
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 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 .

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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

Resource links provided by the National Library of Medicine

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

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




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 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

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


Locations
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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
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Study Director: David Price, MD DexCom, Inc.
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Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT03566693    
Other Study ID Numbers: PTL-902822
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
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
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