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

Verbeeten, Kate C.; Trejo, Maria Esther Perez; Tang, Ken; Chan, Jason R.; Courtney, Jennilea; Bradley, Brenda J.; McAssey, Karen; Clarson, Cheril; Kirsch, Susan; Curtis, John E.; Mahmud, Farid H.; Richardson, Christine; Cooper, Tammy; Lawson, Margaret L.

doi:10.1111/pedi.13150

Cited by 19 publications

(17 citation statements)

References 16 publications

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“…As a result, there was a floor effect, which would have impacted results in our study. CGM offering LGS was found to be associated with lower fear of hypoglycemia in participants and their parents as measured by the Hypoglycemia Fear Scare 18 …”

Section: Discussionmentioning

confidence: 95%

Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial

et al. 2020

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Objective To determine whether timing of CGM initiation offering low glucose suspend (LGS) affects CGM adherence in children and youth starting insulin pump therapy. Methods 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. Results 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). Conclusion 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.

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Section: Discussionmentioning

confidence: 95%

Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial

et al. 2020

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“…Data on SAP in a pediatric population studying the effect on HbA1c, hypoglycemia and/or QoL, are emerging (10,(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(26)(27)(28). Eleven observational studies and five RCTs introducing RT-CGM in pediatric pump users, have been performed from 2010 until mid-2022, including 16 to 622 (of which 129 on SAP) children/adolescents with T1D per study, with a trial duration of 2 to 36 months.…”

Section: Discussionmentioning

confidence: 99%

“…Although the clinical benefits of RT-CGM have been demonstrated in randomized controlled trials (RCTs) before, they often only analyzed 6- or 12-month data or even less ( 10 , 13 – 19 , 21 , 22 , 24 ), and therefore do not inform about sustainability of its effects. Furthermore, most RCTs do not assess the effect of novel technology on hospitalizations because being hospitalized due to hypoglycemia or ketoacidosis is usually an exclusion criterion.…”

Section: Discussionmentioning

confidence: 99%

“…This is accomplished by interrupting insulin delivery when glucose values reach or drop below a specified threshold [Low-Glucose Suspend (LGS) system] or even before hypoglycemia is reached (predictive LGS) (12). Eleven observational studies and five randomized controlled trials have been performed in children (10,(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28), demonstrating improvements in HbA1c (10, 14-16, 19, 23, 24), in hypoglycemia (16)(17)(18)(19)(20)25) and QoL (13,15,21,22,27), but data on the real-world impact of SAP in children for a period of more than 12 months are scarce (23).…”

Section: Introductionmentioning

confidence: 99%

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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

Ridder

Charleer²,

Jacobs³

et al. 2022

Front. Pediatr.

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ObjectiveReal-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 methodsWe 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).ResultsBetween 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.ConclusionRT-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].

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“…In the CGM TIME trial, which involved 144 children with type 1 diabetes for at least 1 year, patients were treated using a sensor‐augmented personal insulin pump with the LGS function, and parents completed the HFS‐II questionnaire at baseline and after 12 months of treatment. The study demonstrated that personal insulin pump therapy with the LGS function significantly reduced the FOH (Verbeeten et al., 2021 ). Another technology used in sensor‐augmented personal insulin pumps predicts drops in glucose levels 30 min before reaching a given value and allows insulin delivery to be automatically suspended and then automatically continued when the downward trend in blood glucose has subsided.…”

Section: Modern Technologies and Fohmentioning

confidence: 99%

Fear of hypoglycemia—An underestimated problem

2022

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Introduction: Fear of hypoglycemia (FOH) is a phenomenon that affects people with diabetes experiencing hypoglycemia. On the one hand, FOH is an adaptive mechanism that helps to protect patients from hypoglycemia and its consequences. On the other hand, the non-normative level of FOH causes anxiety and tension, disturbs normal functioning, and makes normoglycemia maintenance difficult. Objective:The main objective of this review was to describe factors influencing FOH and methods of measurement of FOH levels. Moreover, we highlighted the impact of the new technologies used in diabetes therapy on FOH and different therapeutic possibilities helping patients cope with excessive levels of FOH. We also presented clinical cases of patients with high FOH levels met in clinical practice and discussed methods to better diagnose and assist people with this kind of problem. Methods:We searched for studies and articles via PubMed using the keywords fear of hypoglycemia, diabetes, and hypoglycemia. From screened documents identified from literature search, 67 articles were included in our review. Results:We divided results from literature screening into five parts: fear of hypoglycemia and hypoglycemia definition, risk factors for the FOH, methods of measuring levels of FOH, therapies for the FOH, and modern technologies. We also described clinical examples of abnormal fear of hypoglycemia in patients. Conclusion:The review highlights the importance of taking into consideration fear of hypoglycemia phenomenon in diabetic patients in everyday clinical practice. K E Y W O R D Sanxiety, diabetes, fear of hypoglycemia, hypoglycemia INTRODUCTIONAnxiety disorders are mental disorders that are not caused by organic injury to the central nervous system, and their symptoms relate mainly to emotional processes. These disorders might be rooted in past experiences that trigger anxiety despite the absence of actual threat at a certain moment (Kępiński, 2020). It is an anticipatory reaction to aThis is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

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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

Cited by 19 publications

References 16 publications

Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial

Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial

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

Fear of hypoglycemia—An underestimated problem

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