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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.

Tracking Information
First Submitted Date  ICMJE June 1, 2018
First Posted Date  ICMJE June 25, 2018
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE July 30, 2018
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • 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
  • 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)
  • 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)
  • 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%)
  • 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
  • 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
  • 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
  • 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)
  • 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
  • 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)
  • 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)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)
Official Title  ICMJE Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)
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 .

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Device: Dexcom G6 CGM System
    continuous glucose monitor
  • Device: Blood glucose meter
    Blue-tooth enabled blood glucose meter
Study Arms  ICMJE
  • Experimental: Continous Glucose Monitor
    Intervention: Device: Dexcom G6 CGM System
  • Active Comparator: Self Monitoring Blood Glucose
    Intervention: Device: Blood glucose meter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 2, 2020)
176
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2018)
207
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03566693
Other Study ID Numbers  ICMJE PTL-902822
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party DexCom, Inc.
Study Sponsor  ICMJE DexCom, Inc.
Collaborators  ICMJE Jaeb Center for Health Research
Investigators  ICMJE
Study Director: David Price, MD DexCom, Inc.
PRS Account DexCom, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP