The MOBILE Study doi:10.1001/jama.2021.7444 Scott

Transcript:The MOBILE Study doi:10.1001/jama.2021.7444 Scott:
The MOBILE Study doi:10.1001/jama.2021.7444 Scott Stadler, PharmD Candidate Funding / Conflict of interest All authors received grant funding from Dexcom to their institution for the conduct of the submitted study Dexcom representatives participated in development of the design of the trial, but were not involved in management, or analysis other than providing the process for the uploading of continuous glucose monitoring data; and were not involved in the preparation of the manuscript or the decision to submit the manuscript for publication. Background Continuous Glucose Monitors How do they work? Continuous glucose monitoring (CGM) devices measure interstitial glucose via small sensors worn on the back of the upper arm or on the abdomen. Users can scan them using affiliated receivers or their smartphone to view their glucose readings. Additionally, real-time CGM devices monitor as frequently as every 5 minutes and can alarm the user of dangerously low or high glucose levels Continuous Glucose Monitors How are they different from traditional monitors? CGMs provide continuous data, whereas traditional blood glucose monitors give insight to only a snapshot in time. Interstitial glucose levels positively correlate with blood glucose levels but can occasionally lag behind true blood glucose levels especially in instances where blood glucose is rapidly increasing or decreasing. Continuous Glucose Monitors Where are they used? For patients with type 1 or type 2 diabetes using intensive insulin regimens, there is strong evidence for use of CGMs to lower/maintain A1c and reduce the incidence of severe hypoglycemia Use of this technology in patients with type 2 diabetes using basal insulin without prandial insulin is not well studied. Roughly 20% of patients with type 2 diabetes in the United States fall within this category Methodology Study Design Type of study: Multicenter, randomized, open-label, parallel-group trial 15 centers in the US participated Duration: 8 months The protocol and informed consent form were approved by a central IRB for 14 centers and a local board for 1 center. Outcomes Primary: HbA1c level at 8 months adjusted for the baseline value Key secondary: CGM-measured time in the target glucose range of 70 to 180 mg/dl Change in CGM time-hyperglycemic, defined as >250 mg/dL Mean glucose level at 8 months adjusted for the baseline value Safety: Severe hypoglycemia (defined as an event that required assistance from another person to administer carbohydrates or other resuscitative action) Severe hyperglycemia including DKA and serious adverse events regardless of causality Interventions Participants