CGM-recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia

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DOI

  • Julie Maria Bøggild Brøsen, Nordsjællands Universitets Hospital - Frederikssund
  • ,
  • Rikke Mette Agesen, Novo Nordisk, Novo Nordisk, Global Res
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  • Amra Ciric Alibegovic, Novo Nordisk, Novo Nordisk, Global Res
  • ,
  • Henrik Ullits Andersen, Steno Diabet Ctr Copenhagen, Steno Diabetes Center, Disputats bedømmelsesudvalg, Faculty of Health and Medical Sciences, Copenhagen University
  • ,
  • Henning Beck-Nielsen, Immunology, Odense Universitetshospital, Odense, Denmark.
  • ,
  • Peter Gustenhoff, Steno Diabetes Center North
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  • Troels Krarup Hansen
  • Christoffer Georg Riber Hedetoft, University of Copenhagen
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  • Tonny Joran Jensen, University of Copenhagen
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  • Charlotte Røn Stolberg, University of Southern Denmark
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  • Claus Bogh Juhl, University Hospital of South West Jutland, University of Southern Denmark, Danish Center for Strategic Research in Type 2 Diabetes, Steno Diabetes Center Odense, Odense, Denmark.
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  • Susanne Søgaard Lerche, Department of Surgery, Sygehus Lillebælt, Kolding Hospital, Kolding, Denmark
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  • Kirsten Nørgaard, Steno Diabet Ctr Copenhagen, Steno Diabetes Center, Disputats bedømmelsesudvalg, Faculty of Health and Medical Sciences, Copenhagen University
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  • Hans-Henrik Parving, Disputats bedømmelsesudvalg, Faculty of Health and Medical Sciences, Copenhagen University
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  • Lise Tarnow, Steno Diabetes Center, Sjaelland, Denmark.
  • ,
  • Ulrik Pedersen-Bjergaard, Nordsjællands Universitets Hospital - Frederikssund
  • ,
  • Birger Thorsteinsson, Nordsjællands Universitets Hospital - Frederikssund

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 sub-study of 4x6 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/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/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 to insulin glargine U100 significantly reduces nocturnal CGM-recorded hypoglycemia.

Original languageEnglish
JournalDiabetes Technology & Therapeutics
ISSN1520-9156
DOIs
Publication statusE-pub ahead of print - 25 Apr 2022

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