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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
- Source :
- Brøsen , J M B , Agesen , R M , Alibegovic , A C , Ullits Andersen , H , Beck-Nielsen , H , Gustenhoff , P , Krarup Hansen , T , Hedetoft , C G R , Jensen , T J , Stolberg , C R , Bogh Juhl , C , Lerche , S S , Nørgaard , K , Parving , H H , Tarnow , L , Thorsteinsson , B & Pedersen-Bjergaard , U 2022 , ' Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia ' , Diabetes Technology & Therapeutics , vol. 24 , no. 9 , pp. 643-654 .
- Publication Year :
- 2022
-
Abstract
- 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).
Details
- Database :
- OAIster
- Journal :
- Brøsen , J M B , Agesen , R M , Alibegovic , A C , Ullits Andersen , H , Beck-Nielsen , H , Gustenhoff , P , Krarup Hansen , T , Hedetoft , C G R , Jensen , T J , Stolberg , C R , Bogh Juhl , C , Lerche , S S , Nørgaard , K , Parving , H H , Tarnow , L , Thorsteinsson , B & Pedersen-Bjergaard , U 2022 , ' Continuous Glucose Monitoring-Recorded Hypoglycemia with Insulin Degludec or Insulin Glargine U100 in People with Type 1 Diabetes Prone to Nocturnal Severe Hypoglycemia ' , Diabetes Technology & Therapeutics , vol. 24 , no. 9 , pp. 643-654 .
- Notes :
- application/pdf, English
- Publication Type :
- Electronic Resource
- Accession number :
- edsoai.on1372660522
- Document Type :
- Electronic Resource