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Continuous glucose monitoring as equinox of nocturnal and daytime hypoglycaemia in type 1 diabetes : insights from the randomized controlled HypoDE trial
Hermanns, Norbert; Heinemann, Lutz; Kulzer, Bernhard; u. a. (2025): Continuous glucose monitoring as equinox of nocturnal and daytime hypoglycaemia in type 1 diabetes : insights from the randomized controlled HypoDE trial, in: Diabetes research and clinical practice, Amsterdam: Elsevier, Jg. 224, Nr. 112228, S. 1–8, doi: 10.1016/j.diabres.2025.112228.
Faculty/Chair:
Title of the Journal:
Diabetes research and clinical practice
ISSN:
1872-8227
0168-8227
Publisher Information:
Year of publication:
2025
Volume:
224
Issue:
112228
Pages:
Language:
English
Abstract:
Aims:
This study re-analysed data from the HypoDE trial to assess the prevalence of nocturnal hypoglycaemia, evaluate the impact of continuous glucose monitoring (CGM) on nocturnal and daytime hypoglycaemia, and explore their influence on severe hypoglycaemia (SH).
Methods:
The HypoDE trial was a randomized controlled trial involving 141 adults with type 1 diabetes, impaired hypoglycaemia awareness, or prior SH. Participants were randomized to CGM (Dexcom G5) or self-monitoring of blood glucose (control). Outcomes included the percentage of time spent in hypoglycaemia (<3.9 mmol/L, <3.0 mmol/L), episode duration, and SH incidence.
Results:
At baseline, nocturnal hypoglycaemia (<3.0 mmol/L) exposure exceeded daytime by 1.4 percentage points (95 % CI 0.6–2.2; p < 0.002), with episodes lasting 30.7 min longer (CI 21.5–39.9). Using CGM, these differences disappeared (<3.0 mmol/L: 0.3 percentage points, CI 0.7–1.3), while they persisted in the control group. Daytime hypoglycaemia significantly increased SH risk (IRR 1.10 per percentage point, CI 1.01–1.21; IRR 1.04 per minute, CI 1.01–1.07).
Conclusions:
CGM effectively reduced nocturnal and daytime hypoglycaemia. Without CGM, nocturnal hypoglycaemia contributes to daytime risks, while daytime hypoglycaemia elevates SH risk. Expanding CGM access and addressing nocturnal hypoglycaemia in resource-limited settings are critical.
Trial registrationClinicaltrials.gov: NCT02671968.
This study re-analysed data from the HypoDE trial to assess the prevalence of nocturnal hypoglycaemia, evaluate the impact of continuous glucose monitoring (CGM) on nocturnal and daytime hypoglycaemia, and explore their influence on severe hypoglycaemia (SH).
Methods:
The HypoDE trial was a randomized controlled trial involving 141 adults with type 1 diabetes, impaired hypoglycaemia awareness, or prior SH. Participants were randomized to CGM (Dexcom G5) or self-monitoring of blood glucose (control). Outcomes included the percentage of time spent in hypoglycaemia (<3.9 mmol/L, <3.0 mmol/L), episode duration, and SH incidence.
Results:
At baseline, nocturnal hypoglycaemia (<3.0 mmol/L) exposure exceeded daytime by 1.4 percentage points (95 % CI 0.6–2.2; p < 0.002), with episodes lasting 30.7 min longer (CI 21.5–39.9). Using CGM, these differences disappeared (<3.0 mmol/L: 0.3 percentage points, CI 0.7–1.3), while they persisted in the control group. Daytime hypoglycaemia significantly increased SH risk (IRR 1.10 per percentage point, CI 1.01–1.21; IRR 1.04 per minute, CI 1.01–1.07).
Conclusions:
CGM effectively reduced nocturnal and daytime hypoglycaemia. Without CGM, nocturnal hypoglycaemia contributes to daytime risks, while daytime hypoglycaemia elevates SH risk. Expanding CGM access and addressing nocturnal hypoglycaemia in resource-limited settings are critical.
Trial registrationClinicaltrials.gov: NCT02671968.
Keywords: ; ; ;
Diabetestechnology
Continuous glucose monitoring
Nocturnal hypoglycaemia
Severe hypoglycemia
DDC Classification:
RVK Classification:
Type:
Article
Activation date:
May 23, 2025
Project(s):
Versioning
Question on publication
Permalink
https://fis.uni-bamberg.de/handle/uniba/108385