Trial reportPediatric diabetes2021
Fear of hypoglycemia in children with type 1 diabetes and their parents: Effect of pump therapy and continuous glucose monitoring with option of low glucose suspend in the CGM TIME trial.
Trial report in Pediatric diabetes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01295788 (Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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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.
Simultaneous vs Delayed Initiation of REAL-Time Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Recommendations for recognizing, risk stratifying, treating, and managing children and adolescents with hypoglycemia.Frontiers in endocrinology · 2024Pooled it
- Fear of hypoglycemia in children with type 1 diabetes and their parents: Effect of pump therapy and continuous glucose monitoring with option of low glucose suspend in the CGM TIME trial.Pediatric diabetes · 2021Trial
- Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial.Pediatric diabetes · 2021Trial
- A Review of the Fear of Hypoglycemia Literature in Children and Adolescents with Type 1 Diabetes and their Caregivers.Current diabetes reports · 2026Review
- Health-related quality of life and its influencing factors in children with type 1 diabetes in Tunisia: a cross-sectional study.BMJ open · 2025Article
- Parent Feedback on the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) Intervention: A Qualitative Analysis.Children (Basel, Switzerland) · 2025Article
- The Maintain High Blood Glucose subscale of the child hypoglycemia fear survey: proposed preliminary cut points for screening youth with type 1 diabetes.Journal of pediatric psychology · 2024Article
- Relationships of hypoglycemia awareness, hypoglycemia beliefs, and continuous glucose monitoring glycemic profiles with anxiety and depression symptoms in adults with type 1 diabetes using continuous glucose monitoring systems.Diabetes research and clinical practice · 2024Article
- Evidence from clinical trials on high-risk medical devices in children: a scoping review.Pediatric research · 2024Article
- The impact of fear of hypoglycaemia on sleep in adolescents with type 1 diabetes.Diabetic medicine : a journal of the British Diabetic Association · 2023Article
- Continuous Glucose Monitor, Insulin Pump, and Automated Insulin Delivery Therapies for Type 1 Diabetes: An Update on Potential for Cardiovascular Benefits.Current cardiology reports · 2022Review
- Fear of hypoglycemia-An underestimated problem.Brain and behavior · 2022Review
- 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.Frontiers in pediatrics · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
Abstract
To determine if pump therapy with continuous glucose monitoring offering low glucose suspend (LGS) decreases fear of hypoglycemia among children with type 1 diabetes and their parents. The CGM TIME trial is a multicenter randomized controlled trial that enrolled 144 children with type 1 diabetes for at least 1 year (mean duration 3.4 ± 3.1 years) starting pump therapy (MiniMed™ Veo™, Medtronic Canada). CGM (MiniMed™ Enlite™ sensor) offering LGS was introduced simultaneously or delayed for 6 months. Hypoglycemia Fear Scale (HFS) was completed by children ≥10 years old and all parents, at study entry and 12 months later. Simultaneous and Delayed Group participants were combined for all analyses. Subscale scores were compared with paired t-tests, and individual items with paired Wilcoxon tests. Linear regression examined association with CGM adherence. 121/140 parents and 91/99 children ≥10 years had complete data. Mean Behavior subscale score decreased from 21.1 (SD 5.9) to 17.2 (SD 6.1) (p < .001) for children, and 20.7 (SD 7.5) to 17.4 (7.4) (p < .001) for parents. Mean Worry subscale score decreased from 17.9 (SD 11.9) to 11.9 (SD 11.4) (p < .001) for children, and 23.1 (SD 13.2) to 17.6 (SD 10.4) (p < .001) for parents. Median scores for 10/25 child items and 12/25 parent items were significantly lower at 12 months (p < .001). Linear regression found no association between HFS scores and CGM adherence. Insulin pump therapy with CGM offering LGS significantly reduced fear of hypoglycemia not related to CGM adherence in children with type 1 diabetes and their parents.
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