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 - Andersen, Henrik Ullits
AU - Beck-Nielsen, Henning
AU - Gustenhoff, Peter
AU - Hansen, Troels Krarup
AU - Hedetoft, Christoffer Georg Riber
AU - Jensen, Tonny Joran
AU - Stolberg, Charlotte Røn
AU - Juhl, Claus Bogh
AU - Lerche, Susanne Søgaard
AU - Nørgaard, Kirsten
AU - Parving, Hans-Henrik
AU - Tarnow, Lise
AU - Pedersen-Bjergaard, Ulrik
AU - Thorsteinsson, Birger
PY - 2022/9
Y1 - 2022/9
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
KW - Insulin, Long-Acting
KW - Humans
KW - Insulin Glargine/adverse effects
KW - Blood Glucose
KW - Diabetes Mellitus, Type 1/drug therapy
KW - Hypoglycemia/chemically induced
KW - Blood Glucose Self-Monitoring
KW - Glycated Hemoglobin A/analysis
KW - Hypoglycemic Agents/adverse effects
U2 - 10.1089/dia.2021.0567
DO - 10.1089/dia.2021.0567
M3 - Journal article
C2 - 35467938
SN - 1520-9156
VL - 24
SP - 643
EP - 654
JO - Diabetes Technology & Therapeutics
JF - Diabetes Technology & Therapeutics
IS - 9
ER -