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Completed

NCT Number: NCT03566693

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

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).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Keck School of Medicine @ USC, Los Angeles, California, United States

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About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexcom G6 CGM System

Device

continuous glucose monitor

Blood glucose meter

Device

Blue-tooth enabled blood glucose meter

Primary outcomes

  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 outcomes

  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 range 70-180 mg/dL

  2. 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

  3. Phase 1: Change in mean glucose from CGM

    Time frame: Baseline to Month 8

    Between group differences (CGM and SMBG) from baseline to Month 8 of change in mean glucose from CGM

  4. 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)

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

    Time frame: Baseline to Month 8

    Between group differences (CGM and SMBG) from baseline to Month 8 of proportion increasing CGM time in target range by ≥10% and ≥15% (absolute)

  6. 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)

  7. 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%)

  8. 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

  9. 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

  10. 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)

  11. Phase 2: Change in CGM time-hyperglycemic

    Time frame: Month 8 to Month 14 & Baseline to Month 14

    Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hyperglycemic, defined as >250 mg/dL

  12. 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)

  13. Phase 2: Proportion increasing CGM time in target range by ≥10% and ≥15%

    Time frame: 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 proportion increasing

    Month 8 to Month 14 & Baseline to Month 14

  14. 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)

  15. 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

  16. 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

Other outcomes

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

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

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

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  3. Percent decreasing glycated hemoglobin by ≥1.0% (absolute)

    Time frame: Baseline to Month 8, Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    For Phase 1, the endpoints will be evaluated for between group differences in the CGM and SMBG groups from baseline to Month 8. For Phase 2, these endpoints will only be evaluated for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  4. Percent decreasing glycated hemoglobin by ≥1.0% (absolute) OR reaching target glycated hemoglobin (<7.0%)

    Time frame: Baseline to Month 8, Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    For Phase 1, the endpoints will be evaluated for between group differences in the CGM and SMBG groups from baseline to Month 8. For Phase 2, these endpoints will only be evaluated for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  5. Percent decreasing glycated hemoglobin by ≥10% (relative)

    Time frame: Baseline to Month 8, Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    For Phase 1, the endpoints will be evaluated for between group differences in the CGM and SMBG groups from baseline to Month 8. For Phase 2, these endpoints will only be evaluated for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  6. Phase 1 and Phase 2: Change in time <54 mg/dL

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  7. Phase 1 and Phase 2: Proportion of patients with time in target range ≥70% at Month 8

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  8. Phase 1 and Phase 2: Change in the rate of CGM-measured hypoglycemic events

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    A CGM-measured hypoglycemic event is defined as at least 2 sensor values <54 mg/dL that are 15 or more minutes apart plus no intervening values >54 mg/dL; at least 2 sensor values >70 mg/dL that are 30 or more minutes apart with no intervening values ≤70 mg/dL, are required to define the end of an event, at which point the study patient becomes eligible for a new event.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  9. Phase 1 and Phase 2: Change in time >180 mg/dL

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  10. Phase 1 and Phase 2: Change in time 300 mg/dL

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  11. Phase 1 and Phase 2: Area under curve 180 mg/dL

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  12. Phase 1 and Phase 2: Change in self-monitoring blood glucose frequency (self reported and download)

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  13. Phase 1 and Phase 2: Change in total daily insulin units per kg

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  14. Phase 1 and Phase 2: Change in basal units per kg

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  15. Phase 1 and Phase 2: Addition of at least one prandial insulin

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  16. Phase 1 and Phase 2: Addition of at least one GLP-1 analog or SGLT2 inhibitor

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  17. Phase 1 and Phase 2: Change in body weight

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  18. Phase 1 and Phase 2: Change in body mass index

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  19. Phase 1 and Phase 2: Change in blood pressure (systolic and diastolic blood pressure)

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  20. Phase 1 and Phase 2: Change in non HDL cholesterol

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  21. Phase 1 and Phase 2: CGM use frequency (CGM group only)

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  22. Phase 1 and Phase 2: Questionnaires - Diabetes Distress Scale

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    Change in mean score and 4 subscales. Scored on a scale of 1 to 6. Higher scores mean a worse outcome.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  23. Phase 1 and Phase 2: Questionnaires - Glucose Monitoring Satisfaction Survey

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    Change in mean score and 4 subscales.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  24. Phase 1 and Phase 2: Questionnaires - Modified Hill-Bone Medication Adherence Scale

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    Change in total score. Scored on a scale of 8 to 32. Higher scores mean a worse outcome.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  25. Phase 1 and Phase 2: Questionnaires - Clinician Communication Rating Scale

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    Change in mean score on 1 subscale. Scored on a scale of 1 to 4. Higher scores mean a better outcome.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  26. Phase 1 and Phase 2: Questionnaires - Modified Toobert's Scale

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    Change in mean score. Scored on a scale of 0 to 7. Higher scores mean a better outcome.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  27. Phase 1 and Phase 2: Questionnaires - Fear of Hypoglycemia Survey

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    Change in mean score. Scored on a scale of 0 to 4. Higher scores mean a worse outcome.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  28. Phase 1 and Phase 2: Questionnaires - SF12 Health Survey

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    Change in Physical Health Composite score and Mental Health Composite score. Scored on a scale of 0 to 100. Higher scores mean a better outcome.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  29. Phase 1 and Phase 2: Questionnaires - WHO-5 Well-Being Index

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    Change in total score.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  30. Phase 1 and Phase 2: Questionnaires - CGM Satisfaction Survey

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    Given only to the CGM groups at follow-up so no comparison between groups. Scored on a scale from 0 to 100. Higher scores mean a better outcome.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  31. Phase 1 and Phase 2: Questionnaires - Perceived Benefit Questionnaire

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    Given at follow-up only - Each item will be summarized individually; no total or mean score. There is no scale for this questionnaire.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  32. Phase 1 and Phase 2: Questionnaires - Subjective Numeracy Scale

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    Given at study entry only so no comparison between groups. Scored on a scale of 1 to 6. Higher scores mean a better outcome.

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  33. Phase 1 and Phase 2: Safety Events - All adverse events

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  34. Phase 1 and Phase 2: Safety Events - Serious adverse events

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  35. Phase 1 and Phase 2: Safety Events - Severe hypoglycemia (defined as an event that required assistance from another person to administer carbohydrates or other resuscitative action)

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  36. Phase 1 and Phase 2: Safety Events - Diabetic ketoacidosis

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

  37. Phase 1 and Phase 2: Safety Events - Other adverse events

    Time frame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14

    The endpoints are the same for Phase 1 and Phase 2 and will only be listed once.

    Phase 1, between group differences in the CGM and SMBG groups from baseline to Month 8. Phase 2, between group differences for the Discontinue CGM Group (use SMBG only) and the Continue CGM Group from Month 8 to Month 14 as well as for the Continue CGM and the Continue SMBG groups from baseline to Month 14.

Sponsors and collaborators

Lead sponsor

DexCom, Inc.

Industry

Collaborators

  • Jaeb Center for Health Research

Registry information

Official study title

Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)

Acronym: MOBILE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2018
Registry last updated
Apr 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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