Clinical trial NCT03566693: Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)
Official title: Continuous Glucose Monitoring (CGM) in Type 2 Diabetes (T2D) Basal Insulin Users: The Mobile Study (MOBILE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jaeb Center for Health Research
First posted: 2018-06-25
Enrollment: 176
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

Eligibility 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

Primary outcomes:
measure: Phase 1: Change in HbA1c
timeFrame: Baseline to Month 8
measure: Phase 2: Change in CGM time in target range
timeFrame: Month 8 to Month 14
Secondary outcomes:
measure: Phase 1: Change in CGM time in target range
timeFrame: Baseline to Month 8
measure: Phase 1: Change in CGM time-hyperglycemic
timeFrame: Baseline to Month 8
measure: Phase 1: Change in mean glucose from CGM
timeFrame: Baseline to Month 8
measure: Phase 1: Percent decreasing HbA1c by ≥0.5%
timeFrame: Baseline to Month 8
measure: Phase 1: Proportion increasing CGM time in target range by ≥10% and ≥15%
timeFrame: Baseline to Month 8
measure: Phase 1: Percent adding or removing diabetes medications
timeFrame: Baseline to Month 8
measure: Phase 1: Change in HbA1c based on their baseline HbA1c
timeFrame: Baseline to Month 8
measure: Phase 1: Change in CGM glucose variability
timeFrame: Baseline to Month 8
measure: Phase 1: Change in CGM time-hypoglycemic
timeFrame: Baseline to Month 8
measure: Phase 2: Change in HbA1c
timeFrame: Month 8 to Month 14 & Baseline to Month 14
measure: Phase 2: Change in CGM time-hyperglycemic
timeFrame: Month 8 to Month 14 & Baseline to Month 14
measure: Phase 2: Percent decreasing HbA1c by ≥0.5%
timeFrame: Month 8 to Month 14 & Baseline to Month 14
measure: Phase 2: Proportion increasing CGM time in target range by ≥10% and ≥15%
timeFrame: 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
measure: Phase 2: Percent adding or removing diabetes medications
timeFrame: Month 8 to Month 14 & Baseline to Month 14
measure: Phase 2: Change in CGM glucose variability
timeFrame: Month 8 to Month 14 & Baseline to Month 14
measure: Phase 2: Change in CGM time-hypoglycemic
timeFrame: Month 8 to Month 14 & Baseline to Month 14
Other outcomes:
measure: Phase 1 and Phase 2: Percent with glycated hemoglobin <7.0%
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2:Percent with glycated hemoglobin <7.5%
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Percent decreasing glycated hemoglobin by ≥1.0% (absolute)
timeFrame: Baseline to Month 8, Baseline to Month 14
measure: Percent decreasing glycated hemoglobin by ≥1.0% (absolute) OR reaching target glycated hemoglobin (<7.0%)
timeFrame: Baseline to Month 8, Baseline to Month 14
measure: Percent decreasing glycated hemoglobin by ≥10% (relative)
timeFrame: Baseline to Month 8, Baseline to Month 14
measure: Phase 1 and Phase 2: Change in time <54 mg/dL
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Proportion of patients with time in target range ≥70% at Month 8
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Change in the rate of CGM-measured hypoglycemic events
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Change in time >180 mg/dL
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Change in time 300 mg/dL
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Area under curve 180 mg/dL
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Change in self-monitoring blood glucose frequency (self reported and download)
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Change in total daily insulin units per kg
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Change in basal units per kg
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Addition of at least one prandial insulin
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Addition of at least one GLP-1 analog or SGLT2 inhibitor
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Change in body weight
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Change in body mass index
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Change in blood pressure (systolic and diastolic blood pressure)
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Change in non HDL cholesterol
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: CGM use frequency (CGM group only)
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Questionnaires - Diabetes Distress Scale
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Questionnaires - Glucose Monitoring Satisfaction Survey
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Questionnaires - Modified Hill-Bone Medication Adherence Scale
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Questionnaires - Clinician Communication Rating Scale
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Questionnaires - Modified Toobert's Scale
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Questionnaires - Fear of Hypoglycemia Survey
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Questionnaires - SF12 Health Survey
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Questionnaires - WHO-5 Well-Being Index
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Questionnaires - CGM Satisfaction Survey
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Questionnaires - Perceived Benefit Questionnaire
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Questionnaires - Subjective Numeracy Scale
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Safety Events - All adverse events
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Safety Events - Serious adverse events
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: 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)
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Safety Events - Diabetic ketoacidosis
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
measure: Phase 1 and Phase 2: Safety Events - Other adverse events
timeFrame: Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine @ USC
state: California
city: San Diego
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan Internal Medicine
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Park Nicollet International Diabetes Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University Barnes Jewish Hospital
state: Missouri
city: Henderson
country: United States
facility: Las Vegas Endocrinology
state: Nevada
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Morehead City
country: United States
facility: Carteret Medical Group
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research / Diabetes & Endocrinology Consultants, PC
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt Eskind Diabetes Clinic
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Medical Specialists, LLP
state: Texas
Study officials:
affiliation: DexCom, Inc.
name: David Price, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.