MOBILE: Patients with Poorly Controlled Diabetes Could Benefit from CGM

Data from the MOBILE study is providing clinicians with insight into the benefits of continuous glucose monitoring in patients with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin.

A randomized trial conducted in 175 patients with type 2 diabetes, results of the study demonstrate use of continuous glucose monitoring was associated with a significantly greater decrease in HbA1c level compared with blood glucose meter monitoring.

As the prevalence and rate of diabetes mellitus grows among US populations and abroad, outlining the potential benefits of continuous glucose monitoring in patients with diabetes could have a significant impact on disease management and quality of life for millions. With this in mind, the MOBILE study was designed as a randomized clinical trial conducted across 15 centers in the US with enrollment occurring from July 30, 2018-October 30, 2019, and the final follow-up completed on July 7, 2020.

The trial was designed to randomize patients in a 2:1 ratio to continuous glucose monitoring or traditional blood glucose meter monitoring. Patients recruited in the trial were adult patients with type 2 diabetes receiving care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications.

A total of 175 patients, including 116 randomized to continuous glucose monitoring and 59 to blood glucose meter monitoring, were included in the study. This cohort had a mean HbA1c level of 9.1% at baseline, a mean age of 57 (SD, 9) years, 50% were women, 53% were racial/ethnic minority individuals, and 94% went on to complete the trial.

The primary outcome of interest for the trial was HbA1c level at 8 months. Secondary outcomes of interest included time in target glucose range of 70-180 mg/dL, time with glucose levels greater than 250 mg/dL, and mean glucose level at 8 months.

Upon analysis, the mean HbA1c level at baseline decreased from 9.1% at baseline to 8.0% at 8 months in the continuous glucose monitoring group and from 9.0% to 8.4% among those in the blood glucose meter monitoring group (adjusted difference, -0.4% [95% CI, -0.8 to -0.1]; P=.02). Results indicated time in target glucose range was greater among those using continuous glucose monitoring compared to those using blood glucose meter monitoring, with rates of 59% in the continuous glucose monitoring group and 43% in the blood glucose meter monitoring group (adjusted difference, 15% [95% CI, 8 to 23]; P <.001).

Further analysis suggested patients using continuous glucose monitoring spent less time with a glucose level above 250 mg/dL, with the mean percent of time spent above level at 11% among the continuous glucose monitoring group compared to 27% with traditional blood glucose meter monitoring (adjusted difference, -16% [95% CI, -21 to 11]; P <.001). Additionally, patients in the continuous glucose monitoring group had a lower mean glucose value than those in the traditional blood glucose meter monitoring group with a mean glucose value of 179 mg/dL compared with 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P <.001). Investigators noted severe hypoglycemic events occurred among 1 patient in both the continuous glucose monitoring and the traditional blood glucose meter monitoring group.

“In this randomized trial of patients with type 2 diabetes and poor glycemic control treated with basal insulin without prandial insulin and recruited from a primary care setting, HbA1c level improvement at 8 months was significantly greater in participants using CGM than in participants using a BGM alone for glucose monitoring,” wrote investigators.

This study, “Effect of Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Treated with Basal Insulin,” was published in JAMA.