TY - JOUR
T1 - Insight into hypoglycemia frequency in congenital hyperinsulinism: evaluation of a large UK CGM dataset
AU - Worth, Chris
AU - Tropeano, Yesica
AU - Gokul, Pon Ramya
AU - Cosgrove, Karen E
AU - Salomon-Estebanez, Maria
AU - Senniappan, Senthil
AU - Dastamani, Antonia
AU - Banerjee, Indraneel
N1 - Funding Information:
Funding Some of the CGM devices for the RMCH patients were funded by a Momentum grant from Health Innovation Manchester.
Publisher Copyright:
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2022/6/8
Y1 - 2022/6/8
N2 - Introduction Hypoglycemia is often recurrent and severe in patients with congenital hyperinsulinism (CHI). However, there is little information regarding frequency or patterns of episodes to inform clinical management and future trial design. Research design and methods We aimed to describe frequency and patterns of hypoglycemia by varying thresholds through a large continuous glucose monitoring (CGM) dataset. Through the UK CHI centers of excellence, data were analyzed from patients with CHI over a 5-year period. Hypoglycemia thresholds of 3.0 (H3.0), 3.5 (H3.5) and 3.9 (H3.9) mmol/L were used to test threshold change on hypoglycemia frequencies. Results From 63 patients, 3.4 million data points, representing 32 years of monitoring, were analyzed. By UK consensus threshold H3.5, patients experienced a mean 1.3 hypoglycemic episodes per day. Per cent time hypoglycemic increased from 1.2% to 3.3% to 6.9% when threshold changed from H3.0 to H3.5 and H3.9. Merged data showed periodicity of hypoglycemia risk in 24-hour periods in all patients. Conclusions We have evaluated a large dataset to provide a comprehensive picture of the frequency and patterns of hypoglycemia for patients with CHI in the UK. These data establish a baseline risk of hypoglycemia by CGM and provide a framework for clinical management and clinical trial design.
AB - Introduction Hypoglycemia is often recurrent and severe in patients with congenital hyperinsulinism (CHI). However, there is little information regarding frequency or patterns of episodes to inform clinical management and future trial design. Research design and methods We aimed to describe frequency and patterns of hypoglycemia by varying thresholds through a large continuous glucose monitoring (CGM) dataset. Through the UK CHI centers of excellence, data were analyzed from patients with CHI over a 5-year period. Hypoglycemia thresholds of 3.0 (H3.0), 3.5 (H3.5) and 3.9 (H3.9) mmol/L were used to test threshold change on hypoglycemia frequencies. Results From 63 patients, 3.4 million data points, representing 32 years of monitoring, were analyzed. By UK consensus threshold H3.5, patients experienced a mean 1.3 hypoglycemic episodes per day. Per cent time hypoglycemic increased from 1.2% to 3.3% to 6.9% when threshold changed from H3.0 to H3.5 and H3.9. Merged data showed periodicity of hypoglycemia risk in 24-hour periods in all patients. Conclusions We have evaluated a large dataset to provide a comprehensive picture of the frequency and patterns of hypoglycemia for patients with CHI in the UK. These data establish a baseline risk of hypoglycemia by CGM and provide a framework for clinical management and clinical trial design.
KW - blood glucose self-monitoring
KW - hyperinsulinism
KW - hypoglycemia
U2 - 10.1136/bmjdrc-2022-002849
DO - 10.1136/bmjdrc-2022-002849
M3 - Article
C2 - 35675953
SN - 2052-4897
VL - 10
JO - BMJ open diabetes research & care
JF - BMJ open diabetes research & care
IS - 3
M1 - e002849
ER -