Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia

Julie Maria Bøggild Brøsen, Rikke Mette Agesen, Amra Ciric Alibegovic, Henrik Ullits Andersen, Henning Beck-Nielsen, Peter Gustenhoff, Troels Krarup Hansen, Christoffer Georg Riber Hedetoft, Tonny Joran Jensen, Charlotte Røn Stolberg, Claus Bogh Juhl, Susanne Søgaard Lerche, Kirsten Nørgaard, Hans-Henrik Parving, Lise Tarnow, Ulrik Pedersen-Bjergaard, Birger Thorsteinsson

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Background and Aims: Nocturnal hypoglycemia is mainly a consequence of inappropriate basal insulin therapy in type 1 diabetes (T1D) and may compromise optimal glycemic control. Insulin degludec is associated with a lower risk of nocturnal hypoglycemia in T1D. As nocturnal hypoglycemia is often asymptomatic, we applied continuous glucose monitoring (CGM) to detect a more precise occurrence of nocturnal hypoglycemia in the HypoDeg trial, comparing insulin degludec with insulin glargine U100 in people with T1D and previous nocturnal severe hypoglycemia. Materials and Methods: In the HypoDeg trial, 149 people with T1D were included in an open-label randomized cross-over trial. Sixty-seven participants accepted optional participation in the predefined substudy of 4 × 6 days of blinded CGM requiring completion of at least one CGM period in each treatment arm. CGM data were reviewed for hypoglycemic events. Results: Treatment with insulin degludec resulted in a relative rate reduction (RRR) of 36% (95% confidence interval [CI]: 10%-54%; P  < 0.05) in nocturnal CGM-recorded hypoglycemia (≤3.9 mmol/L), corresponding to an absolute rate reduction (ARR) of 0.85 events per person-week. In nocturnal CGM-recorded hypoglycemia (≤3.0 mmol/L), we found an RRR of 53% (95% CI: 36%-65%; P  < 0.001), corresponding to an ARR of 0.75 events per person-week. At the lower detection limit of the CGM (≤2.2 mmol/L), treatment with insulin degludec resulted in a significant RRR of 58% (95% CI: 23%-77%; P  = 0.005). The reductions were primarily due to significant RRRs in asymptomatic hypoglycemia. Conclusion: In people with T1D, prone to nocturnal severe hypoglycemia, insulin degludec compared with insulin glargine U100 significantly reduces nocturnal CGM-recorded hypoglycemia. (#NCT02192450).

Original languageEnglish
JournalDiabetes Technology & Therapeutics
Issue number9
Pages (from-to)643-654
Publication statusPublished - Sept 2022


  • Insulin analogs
  • Insulin degludec
  • Insulin glargine U100
  • Nocturnal hypoglycemia
  • Type 1 diabetes
  • Insulin, Long-Acting
  • Humans
  • Insulin Glargine/adverse effects
  • Blood Glucose
  • Diabetes Mellitus, Type 1/drug therapy
  • Hypoglycemia/chemically induced
  • Blood Glucose Self-Monitoring
  • Glycated Hemoglobin A/analysis
  • Hypoglycemic Agents/adverse effects


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