Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia
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Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia. / Brøsen, Julie Maria Bøggild; Agesen, Rikke Mette; Alibegovic, Amra Ciric; Ullits Andersen, Henrik; Beck-Nielsen, Henning; Gustenhoff, Peter; Krarup Hansen, Troels; Hedetoft, Christoffer Georg Riber; Jensen, Tonny Joran; Stolberg, Charlotte Røn; Bogh Juhl, Claus; Lerche, Susanne Søgaard; Nørgaard, Kirsten; Parving, Hans Henrik; Tarnow, Lise; Thorsteinsson, Birger; Pedersen-Bjergaard, Ulrik.
In: Diabetes Technology & Therapeutics, Vol. 24, No. 9, 2022, p. 643-654.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia
AU - Brøsen, Julie Maria Bøggild
AU - Agesen, Rikke Mette
AU - Alibegovic, Amra Ciric
AU - Ullits Andersen, Henrik
AU - Beck-Nielsen, Henning
AU - Gustenhoff, Peter
AU - Krarup Hansen, Troels
AU - Hedetoft, Christoffer Georg Riber
AU - Jensen, Tonny Joran
AU - Stolberg, Charlotte Røn
AU - Bogh Juhl, Claus
AU - Lerche, Susanne Søgaard
AU - Nørgaard, Kirsten
AU - Parving, Hans Henrik
AU - Tarnow, Lise
AU - Thorsteinsson, Birger
AU - Pedersen-Bjergaard, Ulrik
PY - 2022
Y1 - 2022
N2 - 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. www.clinicaltrials.gov (#NCT02192450).
AB - 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. www.clinicaltrials.gov (#NCT02192450).
KW - Insulin analogs
KW - Insulin degludec
KW - Insulin glargine U100
KW - Nocturnal hypoglycemia
KW - Type 1 diabetes
U2 - 10.1089/dia.2021.0567
DO - 10.1089/dia.2021.0567
M3 - Journal article
C2 - 35467938
AN - SCOPUS:85137135528
VL - 24
SP - 643
EP - 654
JO - Diabetes Technology & Therapeutics
JF - Diabetes Technology & Therapeutics
SN - 1520-9156
IS - 9
ER -
ID: 320655160