Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial.
Adolescent
Blood Glucose
/ metabolism
Blood Glucose Self-Monitoring
Child
Child, Preschool
Diabetes Mellitus, Type 1
/ blood
Female
Glycated Hemoglobin
/ metabolism
Humans
Hypoglycemic Agents
/ administration & dosage
Insulin
/ administration & dosage
Insulin Infusion Systems
Male
Patient Compliance
Time Factors
adherence
continuous glucose monitoring
glycemic control
insulin pump therapy
site differences
Journal
Pediatric diabetes
ISSN: 1399-5448
Titre abrégé: Pediatr Diabetes
Pays: Denmark
ID NLM: 100939345
Informations de publication
Date de publication:
03 2021
03 2021
Historique:
received:
07
09
2020
accepted:
18
10
2020
pubmed:
25
10
2020
medline:
11
1
2022
entrez:
24
10
2020
Statut:
ppublish
Résumé
To determine whether timing of CGM initiation offering low glucose suspend (LGS) affects CGM adherence in children and youth starting insulin pump therapy. A 5-site RCT of pump-naïve subjects (aged 5-18 years) with type 1 diabetes (T1D) for at least 1 year compared simultaneous pump and CGM initiation offering LGS vs standard pump therapy with CGM initiation delayed for 6 months. Primary outcome was CGM adherence (hours per 28 days) (MiniMed™ Paradigm™ Veo™ system; CareLink Pro™ software) over 6 months after CGM initiation. Secondary outcome HbA1c was measured centrally. Linear mixed-models and ordinary least squares models were fitted to estimate effect of intervention, and covariates baseline age, T1D duration, HbA1c, gender, ethnicity, hypoglycemia history, clinical site, and association between CGM adherence and HbA1c. The trial randomized 144/152 (95%) eligible subjects. Baseline mean age was 11.5 ± 3.3(SD) years, T1D duration 3.4 ± 3.1 years, and HbA1c 7.9 ± 0.9%. Six months after CGM initiation, adjusted mean difference in CGM adherence was 62.4 hours per 28 days greater in the Simultaneous Group compared to Delayed Group (P = .007). There was no difference in mean HbA1c at 6 months. However, for each 100 hours of CGM use per 28-day period, HbA1c was 0.39% (95% CI 0.10%-0.69%) lower. Higher CGM adherence was associated with reduced time with glucose >10 mmol/L (P < .001). CGM adherence was higher after 6 months when initiated at same time as pump therapy compared to starting CGM 6 months after pump therapy. Greater CGM adherence was associated with improved HbA1c.
Identifiants
pubmed: 33098212
doi: 10.1111/pedi.13144
pmc: PMC7984035
doi:
Substances chimiques
Blood Glucose
0
Glycated Hemoglobin A
0
Hypoglycemic Agents
0
Insulin
0
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
279-287Subventions
Organisme : Juvenile Diabetes Research Foundation
ID : 80-2010-585
Pays : United States
Informations de copyright
© 2020 The Authors. Pediatric Diabetes published by John Wiley & Sons Ltd.
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