TY - JOUR
T1 - Improved Effectiveness of Immediate Continuous Glucose Monitoring in Hypoglycemia-Prone People with Type 1 Diabetes Compared with Hypoglycemia-Focused Psychoeducation Following a Previous Structured Education
T2 - A Randomized Controlled Trial
AU - Serné, Erik H.
AU - van den Berg, Ingrid Kirsten
AU - Racca, Caterina
AU - van Raalte, Daniël H.
AU - Kramer, Mark H. H.
AU - de Wit, Maartje
AU - Snoek, Frank J.
N1 - Funding Information: This study was initiated, designed, and performed by the investigators and supported by The Netherlands Organisation for Health Research and Development (ZonMW, Project No. 843004115). Publisher Copyright: © Copyright 2023, Mary Ann Liebert, Inc., publishers 2023.
PY - 2023/1/1
Y1 - 2023/1/1
N2 - Objective: Stepped-care has been suggested in the management of patients with problematic hypoglycemia and impaired awareness of hypoglycemia (IAH), initially with psychoeducational programs based on blood glucose awareness training, progressing to diabetes technology in those with persisting need. We examined the clinical effectiveness of stepped-care starting with HypoAware and adding continuous glucose monitoring (CGM) as needed, versus immediate CGM in type 1 diabetes patients with problematic hypoglycemia despite previous structured education in insulin adjustment. Research Design and Methods: A randomized controlled trial (N = 52, mean age 53, 56% females). The stepped-care group attended HypoAware. If a severe hypoglycemic event (SHE) had occurred or IAH was still present after 6 months, CGM was initiated. The control group started immediate CGM. Primary endpoint was the number of participants with self-reported SHE. Secondary outcomes, evaluated at 6 and 12 months, were glycated hemoglobin (HbA1c), the number of participants with IAH time below range (TBR; <54 mg/dL), and patient-reported outcomes (PROs). Results: At 6 months, the number of patients reporting SHE had decreased significantly more in the CGM group: -39% (P < 0.05). HbA1c decreased more in the CGM group (-0.47 percentage-points, P < 0.05). IAH was restored in 31% of patients in both groups. TBR (<54 mg/dL) was lower in the CGM group (-2.4 percentage-points, P < 0.05). In the stepped-care group, 93% started CGM/intermittently scanned CGM. At 12 months, the number of patients reporting SHE was still higher in the stepped-care group. No differences were found in PROs. Conclusions: Immediate start of CGM is more effective than a hypoglycemia-focused reeducation program in reducing SHE risk and attaining glycemic targets in individuals with problematic hypoglycemia and IAH despite previous education in insulin dose adjustment. Trial registration: Netherlands Trial Register, NL64474.029.18.
AB - Objective: Stepped-care has been suggested in the management of patients with problematic hypoglycemia and impaired awareness of hypoglycemia (IAH), initially with psychoeducational programs based on blood glucose awareness training, progressing to diabetes technology in those with persisting need. We examined the clinical effectiveness of stepped-care starting with HypoAware and adding continuous glucose monitoring (CGM) as needed, versus immediate CGM in type 1 diabetes patients with problematic hypoglycemia despite previous structured education in insulin adjustment. Research Design and Methods: A randomized controlled trial (N = 52, mean age 53, 56% females). The stepped-care group attended HypoAware. If a severe hypoglycemic event (SHE) had occurred or IAH was still present after 6 months, CGM was initiated. The control group started immediate CGM. Primary endpoint was the number of participants with self-reported SHE. Secondary outcomes, evaluated at 6 and 12 months, were glycated hemoglobin (HbA1c), the number of participants with IAH time below range (TBR; <54 mg/dL), and patient-reported outcomes (PROs). Results: At 6 months, the number of patients reporting SHE had decreased significantly more in the CGM group: -39% (P < 0.05). HbA1c decreased more in the CGM group (-0.47 percentage-points, P < 0.05). IAH was restored in 31% of patients in both groups. TBR (<54 mg/dL) was lower in the CGM group (-2.4 percentage-points, P < 0.05). In the stepped-care group, 93% started CGM/intermittently scanned CGM. At 12 months, the number of patients reporting SHE was still higher in the stepped-care group. No differences were found in PROs. Conclusions: Immediate start of CGM is more effective than a hypoglycemia-focused reeducation program in reducing SHE risk and attaining glycemic targets in individuals with problematic hypoglycemia and IAH despite previous education in insulin dose adjustment. Trial registration: Netherlands Trial Register, NL64474.029.18.
KW - Blood glucose awareness training
KW - Continuous glucose monitoring
KW - Hypoglycemia
KW - Impaired hypoglycemia awareness
UR - http://www.scopus.com/inward/record.url?scp=85145492316&partnerID=8YFLogxK
U2 - https://doi.org/10.1089/dia.2022.0232
DO - https://doi.org/10.1089/dia.2022.0232
M3 - Article
C2 - 36326825
SN - 1520-9156
VL - 25
SP - 50
EP - 61
JO - Diabetes Technology & Therapeutics
JF - Diabetes Technology & Therapeutics
IS - 1
ER -