Trial reportDiabetes care2012
A randomized clinical trial to assess the efficacy and safety of real-time continuous glucose monitoring in the management of type 1 diabetes in young children aged 4 to <10 years.
Trial report in Diabetes care, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 87 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children (4 to <10 Year Olds)
Strategies to Enhance New CGM Use in Early Childhood: A Randomized Clinical Trial to Assess the Efficacy and Safety of Continuous Glucose Monitoring in Youth < 8 With Type 1 Diabetes
Exercise Snacks and Glutamine to Improve Glucose Control in Adolescents With Type 1 Diabetes
Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes
Who cites it
87 citing papers in PubMed, 6 syntheses or guidelines pooled it, 203 citations in OpenAlex.
- Effect of divergent continuous glucose monitoring technologies on glycaemic control in type 1 diabetes mellitus: A systematic review and meta-analysis of randomised controlled trials.Diabetic medicine : a journal of the British Diabetic Association · 2022Pooled it
- Pooled it
- Effects of real-time continuous glucose monitoring in type 1 diabetes: a meta-analysis of randomized controlled trials.Acta diabetologica · 2021Pooled it
- Intermittently Scanned and Continuous Glucose Monitor Systems: A Systematic Review on Psychological Outcomes in Pediatric Patients.Frontiers in pediatrics · 2021Pooled it
- Type 1 Diabetes in Children and Adolescents: A Position Statement by the American Diabetes Association.Diabetes care · 2018Guideline
- Psychosocial assessment of artificial pancreas (AP): commentary and review of existing measures and their applicability in AP research.Diabetes technology & therapeutics · 2015Pooled it
- Long-term Continuous Glucose Monitor Use in Very Young Children With Type 1 Diabetes: One-Year Results From the SENCE Study.Journal of diabetes science and technology · 2023Trial
- The effect of do-it-yourself real-time continuous glucose monitoring on psychological and glycemic variables in children with type 1 diabetes: A randomized crossover trial.Pediatric diabetes · 2022Trial
- Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial.Pediatric diabetes · 2021Trial
- Trial
- Efficacy of the Flexible Lifestyles Empowering Change intervention on metabolic and psychosocial outcomes in adolescents with type 1 diabetes (FLEX): a randomised controlled trial.The Lancet. Child & adolescent health · 2018Trial
- An alternative sensor-based method for glucose monitoring in children and young people with diabetes.Archives of disease in childhood · 2017Trial
- Glucagon Nasal Powder: A Promising Alternative to Intramuscular Glucagon in Youth With Type 1 Diabetes.Diabetes care · 2016Trial
- Youth and parent measures of self-efficacy for continuous glucose monitoring: survey psychometric properties.Diabetes technology & therapeutics · 2015Trial
- The JDRF CCTN CGM TIME Trial: Timing of Initiation of continuous glucose Monitoring in Established pediatric type 1 diabetes: study protocol, recruitment and baseline characteristics.BMC pediatrics · 2014Trial
- Lessons learned from a pilot RCT of simultaneous versus delayed initiation of continuous glucose monitoring in children and adolescents with type 1 diabetes starting insulin pump therapy.Journal of diabetes science and technology · 2014Trial
- Closed-loop insulin therapy improves glycemic control in children aged <7 years: a randomized controlled trial.Diabetes care · 2013Trial
- Determination of the relationship between mothers' carbohydrate counting knowledge and glycemic control in children with type 1 diabetes.Wiener klinische Wochenschrift · 2026Article
- Article
- The benefits and accuracy of real-time continuous glucose monitoring in children and adolescents with type 1 diabetes attending a summer camp.Journal of diabetes investigation · 2025Article
27 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
objectiveContinuous glucose monitoring (CGM) has been demonstrated to improve glycemic control in adults with type 1 diabetes but less so in children. We designed a study to assess CGM benefit in young children aged 4 to 9 years with type 1 diabetes. RESEARCH DESIGN AND
methodsAfter a run-in phase, 146 children with type 1 diabetes (mean age 7.5 ± 1.7 years, 64% on pumps, median diabetes duration 3.5 years) were randomly assigned to CGM or to usual care. The primary outcome was reduction in HbA(1c) at 26 weeks by ≥0.5% without the occurrence of severe hypoglycemia.
resultsThe primary outcome was achieved by 19% in the CGM group and 28% in the control group (P = 0.17). Mean change in HbA(1c) was -0.1% in each group (P = 0.79). Severe hypoglycemia rates were similarly low in both groups. CGM wear decreased over time, with only 41% averaging at least 6 days/week at 26 weeks. There was no correlation between CGM use and change in HbA(1c) (r(s) = -0.09, P = 0.44). CGM wear was well tolerated, and parental satisfaction with CGM was high. However, parental fear of hypoglycemia was not reduced.
conclusionsCGM in 4- to 9-year-olds did not improve glycemic control despite a high degree of parental satisfaction with CGM. We postulate that this finding may be related in part to limited use of the CGM glucose data in day-to-day management and to an unremitting fear of hypoglycemia. Overcoming the barriers that prevent integration of these critical glucose data into day-to-day management remains a challenge.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.