Background: Minimizing CGM time below range (TBR; T<70 and T<54 mg/dL), is an important therapeutic goal with clinical targets in diabetes (≤4% and ≤1%, respectively). TBR is valuable for clinical management of hypoglycemia, but individual symptomatic episodes are also important to patients. Clinical trials report both TBR and hypoglycemia events (glucose <54 mg/dL for ≥15 min), but associations between the two have not been quantified. The purpose of this work is to compare the associations of TBR with L2 hypoglycemia event rates.
Methods: The relationship between hypoglycemic events and T<70 or T<54 was assessed for cohorts using real-time CGM or SMBG with interval use blinded CGM in 3 trials: DCLP3, DIAMOND, and WISDM. CGM metrics and CGM-detected event rates were calculated over a 6-month period.
Results: There was a strong correlation between hypoglycemic event rates and T<70 or T<54 (R = 0.91-0.93 for CGM and SMBG users). 70 CGM users exceeding the T<70 target (28%) had mean of 3.1 L2 events/week. 85 SMBG users exceeding the T<70 target (59%) had mean 4.1 events/week. Similar trends were seen for the T<54 target. Those meeting T<70 target had on average <1 L2 event/week (CGM: 0.9; SMBG: 0.8 events/week).
Conclusion: TBR was highly correlated with hypoglycemia event rates and participants not meeting hypoglycemic clinical targets had frequent L2 hypoglycemic events.
R. Liggins: Employee; Zucara Therapeutics. Stock/Shareholder; Zucara Therapeutics. P. Calhoun: None. S. Peers: Employee; Zucara Therapeutics. M.C. Riddell: Consultant; Eli Lilly and Company. Speaker's Bureau; Novo Nordisk. Advisory Panel; Supersapiens. Consultant; Dexcom, Inc. Speaker's Bureau; Sanofi. Advisory Panel; Zealand Pharma A/S. Speaker's Bureau; Dexcom, Inc. Stock/Shareholder; Zucara Therapeutics. R.W. Beck: Consultant; Insulet Corporation. Research Support; Insulet Corporation. Consultant; Tandem Diabetes Care, Inc. Research Support; Tandem Diabetes Care, Inc. Consultant; Beta Bionics, Inc. Research Support; Beta Bionics, Inc., Dexcom, Inc., Bigfoot Biomedical, Inc. Consultant; Novo Nordisk. Research Support; Novo Nordisk, Eli Lilly and Company. Consultant; embecta, Vertex Pharmaceuticals Incorporated, Hagar, Ypsomed AG, Sanofi, Zucara Therapeutics, Sequel.
