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

Diabetes Mellitus, Type 2 Clinical Trial

— MOBILE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566693
• Other study ID #: PTL-902822
• Status: Completed
• Phase: N/A
• Start date: July 30, 2018
• Est. completion date: January 4, 2021

Study information

• Verified date: April 2021
• Source: DexCom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: January 4, 2021
• Est. primary completion date: January 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Dexcom G6 CGM System
continuous glucose monitor
• Blood glucose meter
Blue-tooth enabled blood glucose meter

Locations

Country	Name	City	State
United States	Amarillo Medical Specialists, LLP	Amarillo	Texas
United States	University of Michigan Internal Medicine	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Northwestern Memorial	Chicago	Illinois
United States	Henry Ford Medical Center	Detroit	Michigan
United States	Las Vegas Endocrinology	Henderson	Nevada
United States	Keck School of Medicine @ USC	Los Angeles	California
United States	Park Nicollet International Diabetes Center	Minneapolis	Minnesota
United States	Carteret Medical Group	Morehead City	North Carolina
United States	Lucas Research / Diabetes & Endocrinology Consultants, PC	Morehead City	North Carolina
United States	Vanderbilt Eskind Diabetes Clinic	Nashville	Tennessee
United States	Washington University Barnes Jewish Hospital	Saint Louis	Missouri
United States	Scripps Whittier Diabetes Institute	San Diego	California
United States	Iowa Diabetes and Endocrinology Research Center	West Des Moines	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
DexCom, Inc.	Jaeb Center for Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Phase 1 and Phase 2: Percent with glycated hemoglobin <7.0%	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2:Percent with glycated hemoglobin <7.5%	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Percent decreasing glycated hemoglobin by =1.0% (absolute)	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.	Baseline to Month 8, Baseline to Month 14
Other	Percent decreasing glycated hemoglobin by =1.0% (absolute) OR reaching target glycated hemoglobin (<7.0%)	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.	Baseline to Month 8, Baseline to Month 14
Other	Percent decreasing glycated hemoglobin by =10% (relative)	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.	Baseline to Month 8, Baseline to Month 14
Other	Phase 1 and Phase 2: Change in time <54 mg/dL	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Proportion of patients with time in target range =70% at Month 8	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Change in the rate of CGM-measured hypoglycemic events	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Change in time >180 mg/dL	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Change in time 300 mg/dL	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Area under curve 180 mg/dL	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Change in self-monitoring blood glucose frequency (self reported and download)	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Change in total daily insulin units per kg	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Change in basal units per kg	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Addition of at least one prandial insulin	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Addition of at least one GLP-1 analog or SGLT2 inhibitor	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Change in body weight	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Change in body mass index	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Change in blood pressure (systolic and diastolic blood pressure)	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Change in non HDL cholesterol	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: CGM use frequency (CGM group only)	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Questionnaires - Diabetes Distress Scale	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Questionnaires - Glucose Monitoring Satisfaction Survey	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Questionnaires - Modified Hill-Bone Medication Adherence Scale	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Questionnaires - Clinician Communication Rating Scale	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Questionnaires - Modified Toobert's Scale	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Questionnaires - Fear of Hypoglycemia Survey	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Questionnaires - SF12 Health Survey	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Questionnaires - WHO-5 Well-Being Index	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Questionnaires - CGM Satisfaction Survey	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Questionnaires - Perceived Benefit Questionnaire	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Questionnaires - Subjective Numeracy Scale	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Safety Events - All adverse events	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Safety Events - Serious adverse events	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	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)	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Safety Events - Diabetic ketoacidosis	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Other	Phase 1 and Phase 2: Safety Events - Other adverse events	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.	Baseline to Month 8, Month 8 to Month 14 & Baseline to Month 14
Primary	Phase 1: Change in HbA1c	Phase 1: Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to Month 8	Baseline to Month 8
Primary	Phase 2: Change in CGM time in target range	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	Month 8 to Month 14
Secondary	Phase 1: Change in CGM time in target range	Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time in target range 70-180 mg/dL	Baseline to Month 8
Secondary	Phase 1: Change in CGM time-hyperglycemic	Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hyperglycemic, defined as >250 mg/dL	Baseline to Month 8
Secondary	Phase 1: Change in mean glucose from CGM	Between group differences (CGM and SMBG) from baseline to Month 8 of change in mean glucose from CGM	Baseline to Month 8
Secondary	Phase 1: Percent decreasing HbA1c by =0.5%	Between group differences (CGM and SMBG) from baseline to Month 8 of percent decreasing HbA1c by =0.5% (absolute)	Baseline to Month 8
Secondary	Phase 1: Proportion increasing CGM time in target range by =10% and =15%	Between group differences (CGM and SMBG) from baseline to Month 8 of proportion increasing CGM time in target range by =10% and =15% (absolute)	Baseline to Month 8
Secondary	Phase 1: Percent adding or removing diabetes medications	Between group differences (CGM and SMBG) from baseline to Month 8 of percent adding or removing diabetes medications (starting or stopping medications)	Baseline to Month 8
Secondary	Phase 1: Change in HbA1c based on their baseline HbA1c	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%)	Baseline to Month 8
Secondary	Phase 1: Change in CGM glucose variability	Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM glucose variability measured by the coefficient of variation	Baseline to Month 8
Secondary	Phase 1: Change in CGM time-hypoglycemic	Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hypoglycemic, defined as <70mg/dL	Baseline to Month 8
Secondary	Phase 2: Change in HbA1c	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)	Month 8 to Month 14 & Baseline to Month 14
Secondary	Phase 2: Change in CGM time-hyperglycemic	Between group differences (CGM and SMBG) from baseline to Month 8 of change in CGM time-hyperglycemic, defined as >250 mg/dL	Month 8 to Month 14 & Baseline to Month 14
Secondary	Phase 2: Percent decreasing HbA1c by =0.5%	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)	Month 8 to Month 14 & Baseline to Month 14
Secondary	Phase 2: Proportion increasing CGM time in target range by =10% and =15%	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 proportion increasing
Secondary	Phase 2: Percent adding or removing diabetes medications	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)	Month 8 to Month 14 & Baseline to Month 14
Secondary	Phase 2: Change in CGM glucose variability	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	Month 8 to Month 14 & Baseline to Month 14
Secondary	Phase 2: Change in CGM time-hypoglycemic	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	Month 8 to Month 14 & Baseline to Month 14