Introduction: CGM can be used to monitor evolution of dysglycemia in presymptomatic, stage 2 type 1 diabetes (T1D) and to target early initiation of insulin upon reaching stage 3 T1D.
Methods: Participants (N=31) with dysglycemia by A1c, OGTT, CGM and/or home glucose testing (HGT) measures (Table 1) were randomized 2:1 into 6 months unblinded CGM-guided education intervention vs blinded CGM and monitoring only. Surveys included PHQ8, PedsQLFamilyImpact, Tolerance of Uncertainty and Diabetes Knowledge (30 point scale).
Results: Intervention and control group were similar in baseline characteristics (Table), except younger age and significantly higher 2-hour OGTT glucose level in the intervention group. Diabetes knowledge was not significantly different between intervention and control at baseline (22±6 vs 20±7, p=0.61) or 3-month follow-up (23±6 vs 20±4, p=0.28). There were no differences between groups for PHQ8, PedsQLFamilyImpact or Tolerance of Uncertainty at baseline or follow-up to date. Of those diagnosed with stage 3 T1D, CGM average sensor glucose and time >140 mg/dL were higher than at study entry. All participants met ADA stage 3 diagnostic criteria; however, none had A1c≥6.5%.
Conclusion: CGM facilitates early recognition of stage 3 T1D before elevation in HbA1c and metabolic decompensation. Unblinded CGM does not appear to negatively impact quality of life.
B.I.Frohnert: Advisory Panel; Provention Bio, Inc. F.Sepulveda: None. J.E.Stoughton: None. A.Steck: None. K.M.Simmons: Advisory Panel; Provention Bio, Inc., Consultant; Dexcom, Inc., Provention Bio, Inc., Research Support; Novartis.
The Leona M. and Harry B. Helmsley Charitable Trust (G-1911-03463)