PMID- 36275049
OWN - NLM
STAT- PubMed-not-MEDLINE
LR - 20221025
IS - 2296-2360 (Print)
IS - 2296-2360 (Electronic)
IS - 2296-2360 (Linking)
VI - 10
DP - 2022
TI - Effect of nationwide reimbursement of real-time continuous glucose monitoring on
HbA1c, hypoglycemia and quality of life in a pediatric type 1 diabetes
population: The RESCUE-pediatrics study.
PG - 991633
LID - 10.3389/fped.2022.991633 [doi]
LID - 991633
AB - OBJECTIVE: Real-time continuous glucose monitoring (RT-CGM) can improve metabolic
control and quality of life (QoL), but long-term real-world data in children with
type 1 diabetes (T1D) are scarce. Over a period of 24 months, we assessed the
impact of RT-CGM reimbursement on glycemic control and QoL in
children/adolescents with T1D treated with insulin pumps. RESEARCH DESIGN AND
METHODS: We conducted a multicenter prospective observational study. Primary
endpoint was the change in HbA1c. Secondary endpoints included change in time in
hypoglycemia, QoL, hospitalizations for hypoglycemia and/or ketoacidosis and
absenteeism (school for children, work for parents). RESULTS: Between December
2014 and February 2019, 75 children/adolescents were followed for 12 (n = 62) and
24 months (n = 50). Baseline HbA1c was 7.2 ± 0.7% (55 ± 8mmol/mol) compared to
7.1 ± 0.8% (54 ± 9mmol/mol) at 24 months (p = 1.0). Participants with a baseline
HbA1c ≥ 7.5% (n = 27, mean 8.0 ± 0.3%; 64 ± 3mmol/mol) showed an improvement at 4
months (7.6 ± 0.7%; 60 ± 8mmol/mol; p = 0.009) and at 8 months (7.5 ± 0.6%; 58 ±
7mmol/mol; p = 0.006), but not anymore thereafter (endpoint 24 months: 7.7 ±
0.9%; 61 ± 10mmol/mol; p = 0.2). Time in hypoglycemia did not change over time.
QoL for parents and children remained stable. Need for assistance by ambulance
due to hypoglycemia reduced from 8 to zero times per 100 patient-years (p = 0.02)
and work absenteeism for parents decreased from 411 to 214 days per 100
patient-years (p = 0.03), after 24 months. CONCLUSION: RT-CGM in pump-treated
children/adolescents with T1D showed a temporary improvement in HbA1c in
participants with a baseline HbA1c ≥ 7.5%, without increasing time in
hypoglycemia. QoL was not affected. Importantly, RT-CGM reduced the need for
assistance by ambulance due to hypoglycemia and reduced work absenteeism for
parents after 24 months. CLINICAL TRIAL REGISTRATION: [ClinicalTrials.gov],
identifier [NCT02601729].
CI - Copyright © 2022 De Ridder, Charleer, Jacobs, Bolsens, Ledeganck, Van Aken,
Vanbesien, Gies, Casteels, Massa, Lysy, Logghe, Lebrethon, Depoorter, Gillard, De
Block and den Brinker.
FAU - De Ridder, Francesca
AU - De Ridder F
AD - Laboratory of Experimental Medicine and Pediatrics (LEMP) and Member of the
Infla-Med Center of Excellence, Faculty of Medicine and Health Science,
University of Antwerp, Antwerp, Belgium.
AD - Department of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital
(UZA), Antwerp, Belgium.
AD - Fund for Scientific Research (FWO), Brussels, Belgium.
FAU - Charleer, Sara
AU - Charleer S
AD - Department of Endocrinology, University Hospitals Leuven, Catholic University of
Leuven (KU Leuven), Leuven, Belgium.
FAU - Jacobs, Seppe
AU - Jacobs S
AD - Department of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital
(UZA), Antwerp, Belgium.
FAU - Bolsens, Nancy
AU - Bolsens N
AD - Department of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital
(UZA), Antwerp, Belgium.
FAU - Ledeganck, Kristien J
AU - Ledeganck KJ
AD - Laboratory of Experimental Medicine and Pediatrics (LEMP) and Member of the
Infla-Med Center of Excellence, Faculty of Medicine and Health Science,
University of Antwerp, Antwerp, Belgium.
FAU - Van Aken, Sara
AU - Van Aken S
AD - Department of Pediatrics, University Hospital Ghent, Ghent, Belgium.
FAU - Vanbesien, Jesse
AU - Vanbesien J
AD - Department of Pediatrics, University Hospital Brussels, Free University of
Brussels (VUB), Brussels, Belgium.
FAU - Gies, Inge
AU - Gies I
AD - Department of Pediatrics, University Hospital Brussels, Free University of
Brussels (VUB), Brussels, Belgium.
FAU - Casteels, Kristina
AU - Casteels K
AD - Department of Pediatrics, University Hospitals Leuven, Leuven, Belgium.
AD - Department of Development and Regeneration, KU Leuven, Leuven, Belgium.
FAU - Massa, Guy
AU - Massa G
AD - Department of Pediatrics, Jessa Hospital, Hasselt, Belgium.
FAU - Lysy, Philippe A
AU - Lysy PA
AD - Department of Pediatrics, University Hospital Saint-Luc, Brussels, Belgium.
FAU - Logghe, Karl
AU - Logghe K
AD - Department of Pediatrics, General Hospital Delta, Roeselare, Belgium.
FAU - Lebrethon, Marie-Christine
AU - Lebrethon MC
AD - Department of Pediatrics, University Hospital of Liège, Liège, Belgium.
FAU - Depoorter, Sylvia
AU - Depoorter S
AD - Department of Pediatrics, General Hospital Sint-Jan Bruges, Bruges, Belgium.
FAU - Gillard, Pieter
AU - Gillard P
AD - Fund for Scientific Research (FWO), Brussels, Belgium.
AD - Department of Endocrinology, University Hospitals Leuven, Catholic University of
Leuven (KU Leuven), Leuven, Belgium.
FAU - De Block, Christophe
AU - De Block C
AD - Laboratory of Experimental Medicine and Pediatrics (LEMP) and Member of the
Infla-Med Center of Excellence, Faculty of Medicine and Health Science,
University of Antwerp, Antwerp, Belgium.
AD - Department of Endocrinology-Diabetology-Metabolism, Antwerp University Hospital
(UZA), Antwerp, Belgium.
FAU - den Brinker, Marieke
AU - den Brinker M
AD - Laboratory of Experimental Medicine and Pediatrics (LEMP) and Member of the
Infla-Med Center of Excellence, Faculty of Medicine and Health Science,
University of Antwerp, Antwerp, Belgium.
AD - Department of Pediatrics, Antwerp University Hospital (UZA), Antwerp, Belgium.
LA - eng
SI - ClinicalTrials.gov/NCT02601729
PT - Journal Article
DEP - 20221006
PL - Switzerland
TA - Front Pediatr
JT - Frontiers in pediatrics
JID - 101615492
PMC - PMC9582657
OTO - NOTNLM
OT - HbA1c
OT - hypoglycemia
OT - quality of life
OT - real-time continuous glucose monitoring (RT-CGM)
OT - time in range
OT - type 1 diabetes
COIS- KU Leuven received non-financial support for travel from Medtronic and financial
support for travel from Roche for SC. MB reports travel grants from Abbott,
Medtronic, Novo-Nordisk, and had served on the advisory panel for Novo Nordisk.
KC reports travel grants from Medtronic, Sandoz, and has served in an advisory
panel for Novo Nordisk. CDB reports consulting fees and honoraria for speaking
for Abbott, AstraZeneca, Boehringer-Ingelheim, A. Menarini Diagnostics, Eli
Lilly, Medtronic, Novo Nordisk, and Roche. PG serves or has served on the
advisory panel for Novo Nordisk, Sanofi-Aventis, Boehringer-Ingelheim, Janssen
Pharmaceuticals, Roche, Medtronic, and Bayer. Financial compensation for these
activities has been received by KU Leuven. PG serves or has served on the
speaker’s bureau for Merck Sharp and Dohme, Boehringer-Ingelheim, Bayer,
Medtronic, Insulet, Novo Nordisk, Abbott, and Roche. Financial compensation for
these activities has been received by KU Leuven. KU Leuven received for PG
non-financial support for travel from Sanofi-Aventis, A. Menarini Diagnostics,
Medtronic, and Roche. All disclosures were unrelated to the present work. The
remaining authors declare that the research was conducted in the absence of any
commercial or financial relationships that could be construed as a potential
conflict of interest.
EDAT- 2022/10/25 06:00
MHDA- 2022/10/25 06:01
CRDT- 2022/10/24 03:52
PHST- 2022/07/11 00:00 [received]
PHST- 2022/08/26 00:00 [accepted]
PHST- 2022/10/24 03:52 [entrez]
PHST- 2022/10/25 06:00 [pubmed]
PHST- 2022/10/25 06:01 [medline]
AID - 10.3389/fped.2022.991633 [doi]
PST - epublish
SO - Front Pediatr. 2022 Oct 6;10:991633. doi: 10.3389/fped.2022.991633. eCollection
2022.