Nighttime is the worst time: Parental fear of hypoglycemia in young children with type 1 diabetes.
ABSTRACT: BACKGROUND:Fear of hypoglycemia is common in parents of young children with type 1 diabetes (T1D), but little is known about the specific fears that parents most often experience. Hypoglycemia fear has been associated with poorer glycemic control in older children, though not yet studied in a large cohort of very young children. MATERIALS AND METHODS:Parents of 549 children <7?years (mean 5.2?±?1.2?years [19% <3?years]) with a mean diabetes duration of 2.4?±?1.0?years (range 1-6?years) and mean HbA1c 8.2%?±?1.1% (66?±?12?mmol/mol) registered in the T1D Exchange completed the worry scale of the Hypoglycemia Fear Survey modified for parents (HFS-P). RESULTS:Mean parental fear of hypoglycemia worry score was 36.1?±?23.1 (possible range 0-100), with most frequent worries related to the child having a low while asleep and the child not recognizing a low. The mean worry score was not associated with the child's age, glycemic control, or recent severe hypoglycemic event. Parental worries about lows while sleeping were significantly higher in pump users than non-users (61% vs. 45%; P?
Project description:OBJECTIVES:Sleep has physiological and behavioral impacts on diabetes outcomes, yet little is known about the impact of sleep disturbances in children with type 1 diabetes. The current study sought to characterize sleep in children with type 1 diabetes and in their parents and to examine the associations between child sleep, glycemic control and adherence, parent sleep and well-being, parental fear of hypoglycemia, and nocturnal caregiving behavior. METHODS:Surveys were emailed to parents of 2- to 12-year-old participants in the Type 1 Diabetes (T1D) Exchange clinic registry. Clinical data were obtained from the registry for the 515 respondents. RESULTS:In our sample, 67% of children met criteria for poor sleep quality. Child sleep quality was related to glycemic control (HbA1c of 7.9% [63 mmol/mol] in children with poor sleep quality vs 7.6% [60 mmol/mol] in children with non-poor sleep quality; P < 0.001) but not mean frequency of blood glucose monitoring (BGM) (7.6 times/day vs 7.4 in poor/non-poor quality; P = 0.56). Associations were similar for sleep duration. Children with poor sleep quality were more likely to experience severe hypoglycemia (4% in children with poor sleep quality vs 1% in children with non-poor sleep quality; P = 0.05) and more likely to experience DKA (7% vs 4%, respectively; P < 0.001). Poorer child sleep quality was associated with poorer parental sleep quality, parental well-being, and fear of hypoglycemia (P < 0.001 for all). Child sleep was not related to the use of diabetes-related technology (CGM, insulin pump). CONCLUSIONS:Sleep may be a modifiable factor to improve glycemic control and reduce parental distress.
Project description:INTRODUCTION:The role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation. METHODS:The single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano® and an intervention group using SMBG with iPhone plus glucose meter (iBGStar®). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values. RESULTS:Baseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar® group compared to the control group (-0.16 vs. -0.51, p = 0.04). The total insulin dose increased significantly in the iBGStar® group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (-1.4 ± 10.0 vs. -3.9 ± 12.5, p = 0.32). CONCLUSION:The use of iBGStar® resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov: NCT01825382. FUNDING:Sanofi.
Project description:BACKGROUND:Despite the introduction of new insulin analogs, insulin pumps, and continuous glucose monitoring (CGM), young children with type 1 diabetes mellitus (T1D) remain vulnerable to episodes of hypoglycemia because of their unpredictable eating and activity patterns and high degree of insulin sensitivity. Caregivers and young children living with T1D learn to fear hypoglycemia because it is uncomfortable, unpredictable, and dangerous. Up to 60% of caregivers of young children with T1D report moderate to severe levels of fear of hypoglycemia, and caregiver fear of hypoglycemia relates to lower quality of life for families and suboptimal child glycemic control. Yet, until recently, there have been no studies reporting on a targeted intervention to treat caregiver fear of hypoglycemia in families of young children. OBJECTIVE:The aim of this project is to conduct a randomized clinical trial of an innovative, video-based telehealth intervention to treat fear of hypoglycemia in caregivers of young children with T1D versus a relevant, age-appropriate attention control intervention. METHODS:We created the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention by merging age-appropriate T1D education and behavioral parenting strategies with cognitive behavioral therapy strategies that are effective for reducing fear and promoting adaptive coping. REDCHiP uses 10 video-based telehealth sessions that are a combination of group and individual sessions. We will recruit up to 180 families of young children with T1D to participate in this clinical trial from two pediatric diabetes clinics located in the midwestern and southern United States. Once families have been enrolled, we will randomize caregivers based on child age (age 2-3 years or 4-5 years), child sex, and family CGM use to participate in the REDCHiP or attention control intervention. Families will complete 3 assessment visits that coincide with study entry, end of treatment, and 3-month posttreatment. At each assessment visit, we will collect questionnaire data from caregivers, accelerometry data from caregivers and children, CGM data from children, and a blood sample to measure glycated hemoglobin levels from children. RESULTS:Recruitment began in July 2019, and enrollment is ongoing. The first wave of intervention delivery began in December 2019. We anticipate completing enrollment in 2023. Final reporting of results will occur within 12 months of the primary completion date. CONCLUSIONS:If the REDCHiP intervention is efficacious, next steps will be to examine multiple implementation strategies to determine how best to disseminate the intervention to pediatric diabetes clinics around the world. TRIAL REGISTRATION:ClinicalTrials.gov NCT03914547; https://clinicaltrials.gov/ct2/show/NCT03914547. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/17877.
Project description:<b><i>Background:</i></b> Fear of hypoglycemia (FH) is common in parents of young children with type 1 diabetes (T1D) and problematically linked to maladaptive behaviors to avoid low blood glucose, parenting stress, and burnout. This study examined the feasibility and acceptability of a novel group-based telemedicine intervention to reduce FH in parents of young children with T1D. <b><i>Materials and Methods:</i></b> Forty-three families of a young child with T1D (1-6 years of age; diagnosed with T1D for at least 6 months) enrolled in the study and 36 completed the Reducing Emotional Distress for Childhood Hypoglycemia in Parents (REDCHiP) intervention. We assessed intervention feasibility with rates of attrition, intervention attendance, and fidelity to the treatment manual. We assessed acceptability with treatment satisfaction surveys and qualitative interviews (from a subset of completers; <i>n</i>?=?10) about intervention acceptability, facilitators, and challenges. <b><i>Results:</i></b> Study attrition was 21%, including long-term follow-up (16% before or during the treatment phase). On average, parents attended 94% of intervention sessions and fidelity to the treatment manual was 89%. Intervention completers reported high satisfaction with the treatment groups (89% average satisfaction rating). Parent-reported positive influencers of the REDCHiP intervention were increased knowledge, fear awareness, coping strategies, confidence, behavioral parenting strategies, and support, whereas intervention challenges included feeling fearful or overwhelmed, family stress, lack of trust, and difficulty connecting with other group members. <b><i>Conclusions:</i></b> The REDCHiP intervention demonstrated initial feasibility and acceptability. Next steps include determining the intervention's impact on objective parent and child outcomes (e.g., glycemic control, parental FH, and parental stress/distress) as well as large-scale efficacy testing.
Project description:BACKGROUND:In persons with type 1 diabetes (T1D), hypoglycemia is the major limiting factor in achieving optimal glycemic control. All persons with T1D are at risk for hypoglycemia (blood glucose level?<?70?mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1D are at risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1D. FOH also results in increased glycemic variability (GV). A major gap exists in how to manage FOH. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and GV in young adults with T1D to reduce or delay diabetes complications and improve quality of life. We aim to (1) determine the feasibility and acceptability of an eight-week cognitive behavioral therapy (CBT)-based Fear Reduction Efficacy Evaluation (FREE) intervention in young adults with T1D who experience FOH; and (2) determine the impact of the FREE intervention, compared to an attention control group, on the outcomes FOH, self-management, glycemic control (A1C), and glycemic variability (continuous glucose monitoring recordings). METHODS/DESIGN:A randomized controlled trial in 50 young adults aged 18 to 35?years with T1D will be used. Eligible subjects will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior, A1C, and real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE program. The attention control group will participate in eight weekly individual one-hour diabetes self-management education (DSME) sessions and wear a RT-CGM device (to measure GV only) over 8 weeks. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine differences between the FREE and control groups. DISCUSSION:Findings from this proposed pilot study will serve as the foundation for a larger trial to reduce FOH and improve self-management, glycemic control, and GV. TRIAL REGISTRATION:ClinicalTrials.gov: A cognitive behavioral therapy (CBT) intervention to reduce fear of hypoglycemia in type 1 diabetes, NCT03549104. Registered June 7, 2018.
Project description:BACKGROUND:Managing type 1 diabetes (T1D) in young children presents challenges to families and caregivers. Pump therapy may reduce challenges and benefit glycemic control. However, pump use is not universal; parent-reported reasons for lack of uptake are not well described. METHODS:Parents of children <7, with T1D for ≥1 year, in the T1D Exchange registry completed surveys capturing demographic and clinical characteristics, as well as barriers to pump use. Data from pump users were compared to nonusers, and barriers were analyzed among parents who received pump recommendations, but decided against uptake. RESULTS:Young children (N = 515) from 41 sites were identified (mean age 5.2 ± 1.2 years, diabetes duration 2.4 ± 1.0 years, 46% female, and 78% Non-Hispanic White). Overall glycemic control was suboptimal (HbA1c 8.1% ± 1.0%). The majority were pump users (64%, n = 331; nonusers 36%, n = 184). Pump users had longer T1D duration (2.5 ± 1.1 years vs. 2.2 ± 1.0 years, P = 0.001), were more likely to have annual household incomes ≥$75,000 (62% vs. 36%, P < 0.001), have a parent with college education or higher (70% vs. 45%, P < 0.001), perform more frequent blood glucose monitoring (7.5 ± 2.5 times/day vs. 6.5 ± 2.3 times/day, P < 0.001), and use continuous glucose monitoring (CGM) (45% vs. 13%, P < 0.001). Only income, education, frequency of blood glucose monitoring, and CGM use remained significant in a multivariate model including age, sex, ethnicity, and duration of diabetes. Barriers to pump uptake included concerns with physical interference, therapeutic effectiveness, and to a lesser extent, financial burden. CONCLUSIONS:These findings provide an opportunity to address potentially modifiable parent-reported barriers to pump uptake through education and behavioral intervention.
Project description:Background. Prior research has identified diverse worries that parents have about HPV vaccination. We sought to understand how parents prioritize worries and to identify subgroups of parents according to shared patterns of worry. Methods. We surveyed a national sample of 431 U.S. parents of adolescents who reported never having talked to their child's healthcare provider about HPV vaccination. Parents completed a best-worst scaling experiment designed to prioritize 11 common worries about HPV vaccination. The experiment used a balanced incomplete block design to present 11 choice tasks consisting of repeated subsets of worries. We used conditional logistic regression to prioritize worries and latent class models with 1-10 classes to identify subgroups of parents with shared worries. Results. Parents most often worried about long-term side effects of HPV vaccination, which about one-third (36%) ranked as their top worry. Other common top-ranked worries were how new the vaccine is (12%), motives of drug companies (12%), short-term side effects (10%), and that it may be unnecessary (10%). Latent class analyses suggested a relatively large number of distinct worry profiles, with most classes characterized by a worry about long-term side effects in combination with one other worry. Discussion. Our findings suggest that providers should be prepared to address concerns about long-term side effects, as this worry was prioritized across many subgroups of parents. However, to best address worry, a tailored, rather than targeted, communication approach may be needed.
Project description:OBJECTIVE:Hybrid closed-loop (HCL) artificial pancreas (AP) systems are now moving from research settings to widespread clinical use. In this study, the inControl algorithm developed by TypeZero Technologies was embedded to a commercial Tandem t:slim X2 insulin pump, now called Control-IQ, paired with a Dexcom G6 continuous glucose monitor and tested for superiority against sensor augmented pump (SAP) therapy. Both groups were physician-monitored throughout the clinical trial. RESEARCH DESIGN AND METHODS:In a randomized controlled trial, 24 school-aged children (6-12 years) with type 1 diabetes (T1D) participated in a 3-day home-use trial at two sites: Stanford University and the Barbara Davis Center (50% girls, 9.6?±?1.9 years of age, 4.5?±?1.9 years of T1D, baseline hemoglobin A1c 7.35%?±?0.68%). Study subjects were randomized 1:1 at each site to either HCL AP therapy with the Control-IQ system or SAP therapy with remote monitoring. RESULTS:The primary outcome, time in target range 70-180?mg/dL, using Control-IQ significantly improved (71.0%?±?6.6% vs. 52.8%?±?13.5%; P?=?0.001) and mean sensor glucose (153.6?±?13.5 vs. 180.2?±?23.1?mg/dL; P?=?0.003) without increasing hypoglycemia time <70?mg/dL (1.7% [1.3%-2.1%] vs. 0.9% [0.3%-2.7%]; not significant). The HCL system was active for 94.4% of the study period. Subjects reported that use of the system was associated with less time thinking about diabetes, decreased worry about blood sugars, and decreased burden in managing diabetes. CONCLUSIONS:The use of the Tandem t:slim X2 with Control-IQ HCL AP system significantly improved time in range and mean glycemic control without increasing hypoglycemia in school-aged children with T1D during remote monitored home use.
Project description:To correlate glycated hemoglobin (HbA1c) and fear of hypoglycemia scores with physical activity (PA) levels in children and adolescents with type 1 diabetes (T1D) over a period of 2 years. Twenty-eight children and 33 adolescents with T1D have been assessed for their PA profile. Personal and medical data for the patients were collected at baseline (visit 0: V0), 1 year later (V1), and 2 years later (V2). At baseline, children with T1D engaged in less moderate to vigorous PA (MVPA) (p < 0.01) per day than adolescents. These results did not differ across visits. On the contrary, adolescents spent fewer time in vigorous physical activity (VPA) (p < 0.01) than children did (p < 0.01). Fear of hypoglycemia scores correlated significantly with VPA levels (? = -0.41, p = 0.03; ? = -0.44, p = 0.06; ? = -0.61, p = 0.001). For HbA1c (%), significant correlations were reported with VPA levels (? = -0.54, p = 0.02; ? = -0.47, p = 0.03; ? = -0.62, p = 0.01) across visits. Body mass index percentile correlated with total screen time (? = 0.28, p = 0.02; ? = 0.29, p = 0.01; ? = 0.31, p = 0.04) and overall PA levels (? = -0.52, p = 0.02; ? = -0.42, p = 0.03; ? = -0.42, p = 0.01). Performing more vigorous PA a day is associated with better HbA1c with lower perceived fear of hypoglycemia among youth with T1D. Therefore, dedicating more time in VPA may be an appropriate advice for patients with T1D.
Project description:INTRODUCTION:The stable, ultra-long duration of action of insulin degludec (degludec) minimizes fluctuations in glucose-lowering activity over the daily (24-h) dosing period, and comparative studies with other basal insulins suggest that these properties translate into a lower risk of hypoglycemia at equivalent levels of glycemic control. Results from the real-world European multicenter, retrospective chart review study of 2550 patients with type 1 and type 2 diabetes (T1D and T2D) in routine clinical care EU-TREAT (NCT02662114) showed that patients benefited from improved glycemic control and significantly reduced rates of hypoglycemia following a switch to degludec. METHODS:In this post hoc analysis, EU-TREAT patients were stratified into good (??7.5% HbA1c), intermediate (>?7.5 to ??8.5% HbA1c), and poor (>?8.5% HbA1c) glycemic control at baseline to investigate the possibility of differential benefits, either improved control or reduced risk of hypoglycemia, whichever the need. Changes in HbA1c, overall hypoglycemia, and total insulin dose from baseline to 6 and 12 months follow-up were assessed for each group. RESULTS:For both T1D and T2D patients, those in good initial control experienced significant reductions in rates of hypoglycemia and total insulin dose following the switch, without compromising control. Those in poor initial control achieved significant improvements in HbA1c with no change in rates of hypoglycemia or total insulin dose. CONCLUSION:This analysis expands the findings of EU-TREAT by showing differential changes in the clinical endpoints depending on particular need. It introduces the possibility that the differential benefits of degludec could address two of the renowned clinical challenges faced when treating diabetes: improving glycemic control for optimal management of T1D and titrating insulin dose in T2D, both without fear of increased hypoglycemia. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02662114. FUNDING:Novo Nordisk A/S.