The Effect of Insulin Degludec Versus Insulin Glargine U100 on Glucose Metrics Recorded During Continuous Glucose Monitoring in People With Type 1 Diabetes and Recurrent Nocturnal Severe Hypoglycemia.

Aim: Comparing continuous glucose monitoring (CGM)-recorded metrics during treatment with insulin degludec (IDeg) versus insulin glargine U100 (IGlar-100) in people with type 1 diabetes (T1D) and recurrent nocturnal severe hypoglycemia.
Materials and Methods: This is a multicenter, two-year, randomized, crossover trial, including 149 adults with T1D and minimum one episode of nocturnal severe hypoglycemia within the last two years. Participants were randomized 1:1 to treatment with IDeg or IGlar-100 and given the option of six days of blinded CGM twice during each treatment. CGM traces were reviewed for the percentage of time-within-target glucose range (TIR), time-below-range (TBR), time-above-range (TAR), and coefficient of variation (CV).
Results: Seventy-four participants were included in the analysis. Differences between treatments were greatest during the night (23:00-06:59). Treatment with IGlar-100 resulted in 54.0% vs 49.0% with IDeg TIR (70-180 mg/dL) (estimated treatment difference [ETD]: -4.6%, 95% confidence interval [CI]: -9.1, -0.0, P = .049). TBR was lower with IDeg at level 1 (54-69 mg/dL) (ETD: -1.7% [95% CI: -2.9, -0.5], P < .05) and level 2 (<54 mg/dL) (ETD: -1.3% [95% CI: -2.1, -0.5], P = .001). TAR was higher with IDeg compared with IGlar-100 at level 1 (181-250 mg/dL) (ETD: 4.0% [95% CI: 0.8, 7.3], P < .05) and level 2 (> 250 mg/dL) (ETD: 4.0% [95% CI: 0.8, 7.2], P < .05). The mean CV was lower with IDeg than that with IGlar-100 (ETD: -3.4% [95% CI: -5.6, -1.2], P < .05).
Conclusion: For people with T1D suffering from recurrent nocturnal severe hypoglycemia, treatment with IDeg, compared with IGlar-100, results in a lower TBR and CV during the night at the expense of more TAR.
Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: J.M.B.B., H.B.-N., T.K.H., C.H., T.J.J., C.R.S., S.S.L., H.-H.P., L.T., and B.T. have no competing financial interests. U.P.-B. has served on advisory boards for Novo Nordisk and Sanofi and has received lecture fees from Abbott, Sanofi, and Novo Nordisk. A.C.A. and R.M.A. have been employed by Novo Nordisk A/S since September 2019 (after the finalization of the study). H.U.A. is on advisory boards for Abbott Laboratories, Astra Zeneca, and Novo Nordisk; has received lecture fees from Nordic Infucare; and owns stock in Novo Nordisk. P.G. has served on advisory boards for Abbott Laboratories, Astra Zeneca, Boehringer Ingelheim, Novo Nordisk, and Sanofi. C.B.J. serves on advisory boards for Novo Nordisk. K.N. serves as an advisor to Abbott Laboratories, Medtronic, and Novo Nordisk; has received fees for speaking from Bayer, Medtronic, Novo Nordisk, Roche Diabetes Care, Rubin Medical, Sanofi, and Zealand Pharma; and owns stock in Novo Nordisk.