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

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 8.0-11.5%. 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 .

Major Inclusion Criteria:

- Age 30 or older

- Diagnosis of Type 2 diabetes

- HbA1c between 8.0-11.5%

- 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