The psychosocial outcomes of advanced hybrid closed-loop system in children and adolescents with type 1 diabetes.

The study was carried out to determine the psychosocial outcomes of advanced hybrid closed-loop (AHCL) systems in children and adolescents with type 1 diabetes (T1D). Single-center and cohort study with a duration 6 months consisted of 60 children and adolescents with T1D. Standard clinical procedures, including both glycemic indicators, e.g., sensor-measured time within the 70-180 mg/dL range and glycated hemoglobin (HbA1c) levels, and psychosocial metrics were used for data collection. The psychosocial metrics included the Pediatric Quality of Life Inventory (PedsQL) 3.0 Diabetes Module for both children (8-12 years) and parents; the Quality of Life for Youth scale for adolescents (13-18 years); the Strengths and Difficulties Questionnaire (SDQ); the Hypoglycemia Fear Survey for Children (HFS-C); the Revised Child Anxiety and Depression Scale (R-CADS); and AHCLS-specific DTSEQ satisfaction and expectation survey. These metrics were evaluated at the baseline and after 6 months of AHCL use. Of the 60 children and adolescents with T1D for whom the AHCL system was utilized, 41 of them, 23 female and 18 male, completed the surveys. The mean age of the 41 children and adolescents was 12.5 ± 3.2 (min. 6.7, max. 18) years. The time spent within the target glycemic range, i.e., time-in-range (TIR), improved from 76.9 ± 9% at the baseline to 80.4 ± 5% after 6 months of AHCL system use (p = 0.03). Additionally, HbA1c levels reduced from 7.1% ± 0.7% at the baseline to 6.8% ± 0.8% after 6 months of AHCL system use (p = 0.03). The most notable decline in HbA1c was observed in participants with higher baseline HbA1c levels. All patients' HFS-C and AHCL system-specific DTSEQ satisfaction and expectation survey scores were within the normal range at the baseline and remained unchanged during the follow-up period. No significant difference was found in the R-CADS scores of children and adolescents between baseline and after 6 months of AHCL system use. However, there was a significant decrease in the R-CADS scores of the parents. Patients' PedsQL scores were high both at the baseline and after 6 months. The SDQ scores were high at baseline, and there was no significant improvement at the end of 6 months.  Conclusion: This is the first study to investigate in detail the psychosocial outcomes of AHCL system use in T1D patients and their parents. Although state-of-the-art technologies such as AHCL provide patients with more flexibility in their daily lives and information about glucose fluctuations, the AHCL resulted in a TIR above the recommended target range without a change in QOL, HFS-C, SDQ, and R-CADS scores. The scores obtained from the R-CADS conducted by the parents of the children indicated that the use of pumps caused a psychological improvement in the long term, with a significant decrease in the R-CADS scores of the children and adolescents with T1D. What is Known: • Previous studies focused on clinical outcomes of AHCL systems in pediatric T1D patients, showing glycemic control improvements. • Limited attention given to psychosocial outcomes of AHCL systems in children and adolescents with T1D. • Crucial psychosocial factors like quality of life, emotional well-being, and fear of hypoglycemia underexplored in AHCL system context. What is New: • First study to comprehensively examine psychosocial outcomes of AHCL systems in pediatric T1D patients. • Study's robust methodology sets new standard for diabetes technology research and its impact on qualiy of life.

FREE: A randomized controlled feasibility trial of a cognitive behavioral therapy and technology-assisted intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes.

OBJECTIVE: The purpose of this study was to test the preliminary effectiveness of a cognitive behavioral therapy intervention (Fear Reduction Efficacy Evaluation [FREE]) designed to reduce fear of hypoglycemia in young adults with type 1 diabetes. The primary outcome was fear of hypoglycemia, secondary outcomes were A1C, and glycemic variability. METHODS: A randomized clinical trial was used to test an 8-week intervention (FREE) compared to an attention control (diabetes education) in 50 young adults with type 1 diabetes who experienced fear of hypoglycemia at baseline. All participants wore a continuous glucose monitor for the 8-week study period. Self-reported fear of hypoglycemia point-of-care A1C testing, continuous glucose monitor-derived glucose variability were measured at baseline, Week 8, and Week 12 (post-program). RESULTS: Compared to controls, those participating in the FREE intervention experienced a reduction in fear of hypoglycemia (SMD B = -8.52, p = 0.021), change in A1C (SMD B = 0.04, p = 0.841) and glycemic variability (glucose standard deviation SMD B = -2.5, p = 0.545) by the end of the intervention. This represented an 8.52% greater reduction in fear of hypoglycemia. CONCLUSION: A cognitive behavioral therapy intervention (FREE) resulted in improvements in fear of hypoglycemia. CLINICALTRIALS: govNCT03549104.

Impact of Flash Glucose Monitoring on the Fear of Hypoglycemia Phenomenon in Adults with Type 1 Diabetes.

Objective: To assess the clinical impact of flash glucose monitoring (FGM) systems on fear of hypoglycemia (FoH) and quality of life in adults with type 1 diabetes mellitus (T1DM). Methods: Prospective quasi-experimental study with a 12-month follow-up. People with T1DM (18-80 years old) and self-monitoring by blood capillary glycemia controls were included. The FH15 questionnaire, a survey validated in Spanish in a comparable study population, was used to diagnose FoH with a cutoff point of 28 points. Results: A total of 181 participants were included, with a FoH prevalence of 69% (n = 123). A mean reduction in FH15 score of -4 points (95% confidence interval [-5.5 to -3]; P < 0.001) was observed, along with an improvement in quality of life (EsDQOL-test (Diabetes Quality of Life, Spanish version), -7 points [-10; -4], P < 0.001) and satisfaction with treatment (Diabetes Treatment Satisfaction questionnaire, self-reported version [DTSQ-s] test, +4.5 points [4; 5.5], P < 0.001). At the end of the follow-up, 64.2% of the participants saw an improved FoH intensity, compared to 35.8% who scored the same or higher. This improvement in FoH status was associated with a higher time-in-range at the end of the follow-up (P = 0.003), as well as a lower time spent in hyperglycemia (P = 0.005). In addition, it was linked to participants with a high baseline FoH levels (P < 0.001) and those who were university degree holders (P = 0.07). Conclusions: FGM is associated with an overall reduction of FoH in adults with T1DM and with an increase in their quality of life. Nevertheless, a significant percentage of patients may experience an increase of this phenomenon leading to clinical repercussions and a profound impact on quality of life.

A novel approach to understanding and assessing the emotional side of type 1 diabetes: The Type 1-Diabetes Distress Assessment System.

AIMS: To describe the development of a novel, conceptually sound instrument with contemporary content for assessing diabetes distress (DD) among adults with type 1 diabetes. METHODS: Qualitative interviews with 15 adults and 7 clinicians were used to develop Core (intensity of DD emotional burden) and primary Source (key DD contributors) items. These were administered to a national sample recruited from the TCOYD Research Registry, T1D Exchange and our previous studies. Exploratory and confirmatory factor analyses were undertaken, along with reliability and construct validity studies, and cut-point analyses to determine elevated DD. RESULTS: Analyses based on 650 respondents yielded an 8-item Core DD scale (α = 0.95) and 10 2- or 3-item DD Source Scales (α range = 0.53-0.88): Financial Worries, Interpersonal Challenges, Management Difficulties, Shame, Hypoglycemia Concerns, Healthcare Quality, Lack of Diabetes Resources, Technology Challenges, Burden to Others and Worries about Complications. Core and Source scores were significantly associated with criterion variables: Higher DD scores were significantly linked with higher HbA1C, more frequent episodes of severe hypoglycaemia, missed boluses, and poorer quality of life (p > 0.001). A ≥2.0 scale cut-point to define elevated DD is suggested. CONCLUSIONS: The new T1-Diabetes Distress Assessment System demonstrated good reliability and validity, and with measures of both Core emotional burden and Sources of DD, it provides a contemporary, flexible and practical approach to assessing DD that can be used seamlessly to inform intervention for clinicians and researchers.

Impact of 6-months of an advanced hybrid closed-loop system on sleep and psychosocial outcomes in youth with type 1 diabetes and their parents.

INTRODUCTION: Youth with type 1 diabetes (T1D) and parents experience reduced quality of life and sleep quality due to nocturnal monitoring, hypoglycemia fear, and diabetes-related disruptions. This study examined the sleep and quality of life impact of advanced technology. METHODS: Thirty-nine youth with T1D, aged 2-17 years, starting an advanced hybrid closed-loop (HCL) system and a parent participated in an observational study. Surveys, actigraphy, sleep diaries, and glycemic data (youth) were captured prior to HCL, at one week, 3 months, and 6 months. Outcomes were modeled using linear mixed effects models with random intercepts to account for within-subject correlation, with least-squares means at each timepoint compared to baseline. RESULTS: Parents and youth reported improvements in health-related quality of life and fear of hypoglycemia after HCL initiation. Concurrently, nocturnal glycemia improved. Actigraphy-derived sleep outcomes showed improved 6 month adolescent efficiency and 3 and 6 month parent wake after sleep onset. Additionally, parents reported improved subjective sleep quality and child sleep-related impairment at 3 months. CONCLUSIONS: With nocturnal glycemic improvements in youth using HCL technology, some aspects of parent and youth sleep and quality of life improved. This may reflect decreased parental monitoring and worry and highlights benefits for youth beyond glycemia.

Testing 3 Digital Health Platforms to Improve Mental Health Outcomes in Adults With Type 1 Diabetes: A Pilot Trial.

OBJECTIVE: Our aim in this study was to examine the potential impact of a 3-pronged digital health pilot intervention (TRIFECTA) on diabetes distress and depressive symptoms among adults with type 1 diabetes (T1D) in British Columbia. METHODS: We recruited 60 adults with T1D (mean age 38.9±15.1 years, 75% female, 77% Caucasian) who participated in the 6-month pilot intervention involving 3 digital health platforms: monthly, provider-led, group-based sessions over Zoom (virtual huddles); a WhatsApp peer texting group; and a web-based "Ask-the-expert" portal. Assessments were conducted at baseline and 6 months and measured diabetes distress (T1D Diabetes Distress Scale), depressive symptoms (9-item Personal Health Questionnaire), and TRIFECTA engagement metrics. RESULTS: Participation in TRIFECTA was associated with significant reductions in Overall Distress (p=0.011) and 4 distress subscales: Powerlessness (p=0.006), Management Distress (p=0.001), Hypoglycemia Distress (p=0.029), and Eating Distress (p<0.001). A higher number of virtual huddles attended predicted lower Overall Distress (p=0.019) and Family/Friends Distress (p=0.023). A higher number of "Ask-the-expert" posts viewed predicted lower Overall Distress (p=0.046), whereas a higher number of WhatsApp messages posted predicted lower Management Distress (p=0.006). Furthermore, engagement in all 3 metrics was a predictor for lower Negative Social Perceptions Distress (p<0.05). No associations were seen in other distress subscales or for depressive symptoms. CONCLUSIONS: Participation in TRIFECTA was linked to reduced diabetes distress levels, but not depressive symptoms, in a platform-dependent manner. This study provides promising pilot data for a subsequent large-scale and fully powered randomized controlled trial.

Disturbed hippocampal histidine metabolism contributes to cognitive impairment induced by recurrent nonsevere hypoglycemia in diabetes.

Hypoglycemia is a common adverse reaction to glucose-lowering treatment. Diabetes mellitus (DM) combined with recurrent nonsevere hypoglycemia (RH) can accelerate cognitive decline. Currently, the metabolic pattern changes in cognition-related brain regions caused by this combined effect of DM and RH (DR) remain unclear. In this study, we first characterized the metabolic profiles of the hippocampus in mice exposed to DR using non-targeted metabolomic platforms. Our results showed that DR induced a unique metabolic pattern in the hippocampus, and several significant differences in metabolite levels belonging to the histidine metabolism pathway were discovered. Based on these findings, in the follow-up experiment, we found that histidine treatment could attenuate the cognitive impairment and rescue the neuronal and synaptic damage induced by DR in the hippocampus, which are closely related to ameliorated mitochondrial injury. These findings provide new insights into the metabolic mechanisms of the hippocampus in the progression of DR, and l-histidine supplementation may be a potential metabolic therapy in the future.

Significant reduction in diabetes distress and improvements in psychosocial outcomes: A pilot test of an intervention to reduce diabetes distress in adults with type 1 diabetes and moderate-to-severe diabetes distress (REDUCE).

AIM: To pilot-test an intervention, co-designed with people with type 1 diabetes (T1DM) and diabetes specialist nurses, to reduce diabetes distress (DD) in adults with T1DM and moderate-to-severe DD. METHODS: A group-based programme to reduce DD in people with T1DM and moderate-to-severe DD (REDUCE) was pilot-tested in four groups with five bi-weekly two and a half-hour meetings facilitated by two trained diabetes specialist nurses. Data collection included baseline and post-intervention questionnaires measuring DD and psychosocial outcomes and semi-structured interviews with participants post-intervention (n = 18). Data were analysed using descriptive statistics and systematic text condensation. RESULTS: Twenty-five adults with T1DM participated in the study. The median age and diabetes duration of participants were 50 (IQR: 32;57.5) years and 26 (IQR: 18;45) years, respectively. Seventeen (68%) were women. The pilot study showed a significant reduction in DD (measured by Type 1 Diabetes Distress Scale) between baseline and post-intervention from 2.6 ± 0.7 to 1.9 ± 0.6 (mean ± SD) (p < 0.001). The largest reductions were seen on the subscales: powerlessness 1.2 ± 1.1, eating distress 0.9 ± 1.2 and fear of hypoglycaemia 0.8 ± 1.0 (mean ± SD). Significant improvements were also seen for quality of life, diabetes empowerment and emotion regulation. Qualitative data showed that REDUCE supported participants in verbalizing emotions and seeing worries in a more constructive perspective. Acknowledgement of negative diabetes experiences eased negative self-judgments. Sharing experiences among peers increased relatedness and reduced loneliness. CONCLUSION: Participation in REDUCE was associated with significant reduction in DD and significant increase in quality of life. Larger scale studies are planned to determine sustained effectiveness of REDUCE.

Psychometric properties of an innovative smartphone application to investigate the daily impact of hypoglycemia in people with type 1 or type 2 diabetes: The Hypo-METRICS app.

INTRODUCTION: The aim of this study was to determine the acceptability and psychometric properties of the Hypo-METRICS (Hypoglycemia MEasurement, ThResholds and ImpaCtS) application (app): a novel tool designed to assess the direct impact of symptomatic and asymptomatic hypoglycemia on daily functioning in people with insulin-treated diabetes. MATERIALS AND METHODS: 100 adults with type 1 diabetes mellitus (T1DM, n = 64) or insulin-treated type 2 diabetes mellitus (T2DM, n = 36) completed three daily 'check-ins' (morning, afternoon and evening) via the Hypo-METRICs app across 10 weeks, to respond to 29 unique questions about their subjective daily functioning. Questions addressed sleep quality, energy level, mood, affect, cognitive functioning, fear of hypoglycemia and hyperglycemia, social functioning, and work/productivity. Completion rates, structural validity, internal consistency, and test-retest reliability were explored. App responses were correlated with validated person-reported outcome measures to investigate convergent (rs>±0.3) and divergent (rs<±0.3) validity. RESULTS: Participants' mean±SD age was 54±16 years, diabetes duration was 23±13 years, and most recent HbA1c was 56.6±9.8 mmol/mol. Participants submitted mean±SD 191±16 out of 210 possible 'check-ins' (91%). Structural validity was confirmed with multi-level confirmatory factor analysis showing good model fit on the adjusted model (Comparative Fit Index >0.95, Root-Mean-Square Error of Approximation <0.06, Standardized Root-Mean-square Residual<0.08). Scales had satisfactory internal consistency (all ω≥0.5), and high test-retest reliability (rs≥0.7). Convergent and divergent validity were demonstrated for most scales. CONCLUSION: High completion rates and satisfactory psychometric properties demonstrated that the Hypo-METRICS app is acceptable to adults with T1DM and T2DM, and a reliable and valid tool to explore the daily impact of hypoglycemia.

Effectiveness of educational and behavioural interventions for reducing fear of hypoglycaemia among adults with type 1 diabetes: Systematic review and meta-analyses.

AIMS: To summarize and critically appraise evidence regarding the effectiveness of educational and/or behavioural interventions in reducing fear of hypoglycaemia among adults with type 1 diabetes. METHODS: Systematic searches of medical and psychology databases were conducted. Risk-of-bias was assessed using the Joanna Briggs Institute Critical Appraisal Tools. Data were synthesized using random-effects meta-analyses for randomized controlled trials (RCTs) and narrative synthesis for observational studies. RESULTS: Five RCTs (N = 682) and seven observational studies (N = 1519) met the inclusion criteria, reporting on behavioural, structured education and cognitive-behavioural therapy (CBT) interventions. Most studies assessed fear of hypoglycaemia using the Hypoglycaemia Fear Survey Worry (HFS-W) and Behaviour (HFS-B) subscales. Mean fear of hypoglycaemia at baseline was relatively low across studies. Meta-analyses showed a significant effect of interventions on HFS-W (SMD = -0.17, p = 0.032) but not on HFS-B scores (SMD = -0.34, p = 0.113). Across RCTs, Blood Glucose Awareness Training (BGAT) had the largest effect on HFS-W and HFS-B scores, and one CBT-based program was as effective as BGAT in reducing HFS-B scores. Observational studies showed that Dose Adjustment for Normal Eating (DAFNE) was associated with significant fear of hypoglycaemia reductions. CONCLUSIONS: Current evidence suggests that educational and behavioural interventions can reduce fear of hypoglycaemia. However, no study to date has examined these interventions among people with high fear of hypoglycaemia.

The Influence of Real-Time Continuous Glucose Monitoring on Psychosocial Outcomes in Insulin-Using Type 2 Diabetes.

BACKGROUND: To examine the impact of real-time continuous glucose monitoring (rtCGM) on psychosocial outcomes in adults with insulin-using type 2 diabetes (T2D). METHODS: A total of 174 insulin-using adults with T2D completed questionnaires assessing diabetes distress, hypoglycemic confidence, hypoglycemic fear, device-related emotional burden, and device-related trust before and after a six-month trial of rtCGM. Hemoglobin A1c (HbA1c) was assessed at the same time points; impaired hypoglycemic awareness (IAH) was assessed at baseline. Change in psychosocial outcomes was examined with t tests, then modeled as a function of baseline HbA1c and IAH and simultaneous change in HbA1c in multiple regression analyses. RESULTS: Respondents were predominantly male (57.5%) and non-Hispanic white (67.8%). Significant improvement over the trial was observed in hypoglycemic fear (P = .031), hypoglycemic confidence (P < .001), diabetes distress (P < .001), and device-related emotional burden (P < .001). Impaired hypoglycemic awareness at baseline predicted greater improvement in hypoglycemic fear (P = .002), hypoglycemic confidence (P = .003), diabetes distress (P = .013), and device-related emotional burden (P < .001). Higher baseline HbA1c was linked with greater improvement in hypoglycemic fear (P = .030); HbA1c change over the trial was positively associated with change in diabetes distress (P = .010) and device-related emotional burden (P = .003). CONCLUSIONS: Introduction of rtCGM in adults with insulin-using T2D was associated with significant improvements in diabetes-related psychosocial outcomes over six months. Gains were significantly greater among participants reporting IAH and those with higher HbA1c at baseline, thus providing the first evidence regarding which users might more likely benefit.

Psychosocial Effects of the Loop Open-Source Automated Insulin Delivery System.

AIMS: This study examined the psychosocial impact of Loop, an open-source automated insulin dosing system that has emerged from the diabetes technology "Do-It-Yourself" (DIY) movement. METHODS: Subsamples of 239 adults, 115 children, and 243 parents completed data collection at the time of Loop initiation and 3 and 6 months later. Surveys collected demographic and clinical information, percent time-in-range, HbA1c, and validated psychosocial measures. Analyses included paired t tests and McNemar's tests to compare psychosocial functioning at 3 and 6 months and regression models to assess baseline predictors of psychosocial outcomes at 6 months. RESULTS: Adults reported significant improvements in diabetes distress (t = -7.20 P < .001; t = -8.01, P < .001), sleep quality (t = 6.81, P < .001; t = 2.98, P = .003), fear of hypoglycemia (t = -4.42, P < .001; t = -4.97, P < .001), and hypoglycemia confidence (t = 8.68, P < .001; t = 7.96 P < .001) from baseline to 3 months and 6 months, respectively. Significant improvements in parents' and children's sleep quality and parents' fear of hypoglycemia were also observed. Several baseline characteristics were associated with psychosocial outcomes at 6 months. CONCLUSIONS: The current findings support the broad and sustained benefits of Loop across multiple aspects of psychosocial well-being. Advancement and dissemination of such technologies has the potential to improve mental and physiological health among people living with type 1 diabetes.

The impact of hypoglycaemia on quality of life among adults with type 1 diabetes: Results from "YourSAY: Hypoglycaemia".

AIMS: Research on hypoglycaemia and quality of life (QoL) has focused mostly on severe hypoglycaemia and psychological outcomes, with less known about other aspects of hypoglycaemia (e.g., self-treated episodes) and impacts on other QoL domains (e.g., relationships). Therefore, we examined the impact of all aspects of hypoglycaemia on QoL in adults with type 1 diabetes (T1DM). METHODS: Participants completed an online survey, including assessment of hypoglycaemia-specific QoL (using the 12-item Hypoglycaemia Impact Profile). Mann-Whitney U tests examined differences in hypoglycaemia-specific QoL by hypoglycaemia frequency, severity, and awareness. Hierarchical linear regression examined associations with QoL. RESULTS: Participants were 1028 adults with T1DM (M ± SD age: 47 ± 15 years; diabetes duration: 27 ± 16 years). Severe and self-treated hypoglycaemia and impaired awareness negatively impacted on overall QoL and several QoL domains, including leisure activities, physical health, ability to keep fit/be active, sleep, emotional well-being, spontaneity, independence, work/studies, and dietary freedom. Diabetes distress was most strongly associated with hypoglycaemia-specific QoL, followed by generic emotional well-being, fear of hypoglycaemia, and confidence in managing hypoglycaemia. Hypoglycaemia frequency and awareness were no longer significantly associated with QoL once psychological factors were considered. CONCLUSIONS: Hypoglycaemia negatively impacts on several QoL domains. Psychological factors supersede the effect of hypoglycaemia frequency and awareness in accounting for this negative impact.

No Clinically Relevant Memory Effects in Perinatal Hyperglycemia and Hypoglycemia: A 40-Year Follow-Up of a Small Cohort.

Maternal diabetes mellitus in pregnancy is associated with impairments in memory functions of the offspring in childhood and adolescence but has not been studied in adulthood. The association of perinatal hypoglycemia with memory has not been studied in adulthood either. The combined sequelae of these two risk factors have not been directly compared. We studied general cognitive ability and memory functions in a prospective follow-up of a cohort born in 1971 to 1974. The sample included participants exposed to prenatal hyperglycemia (n = 24), perinatal hypoglycemia (n = 19), or both (n = 7). It also included controls with no early risks (n = 82). We assessed the participants' Intelligence quotient (IQ), working memory, and immediate and delayed recall of both verbal and visual material at the age of 40. We did not find significant differences in IQ or the memory tests between the groups. We did identify an interaction (p = 0.03) of the early risk with the type of digit span task: compared to the controls, the participants exposed to perinatal hypoglycemia had a larger difference between the forward digit span, a measure of attention, and the backward digit span, a measure of working memory processing (p = 0.022). The interaction remained significant when birth weight was controlled for (p = 0.026). Thus, in this small cohort, prenatal hyperglycemia, perinatal hypoglycemia, and their combination appeared relatively benign disorders. The association of these conditions with neurocognitive impairments in adulthood remains unconfirmed. The significance of the working memory difference needs to be verified with a larger sample.

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.

BACKGROUND: Continuous glucose monitoring (CGM) decreases fear of hypoglycemia (FOH) and improves glycemic control among those affected by type 1 diabetes (T1D). No studies to date have examined the impact of using do-it-yourself real-time continuous glucose monitoring (DIY RT-CGM) on psychological and glycemic outcomes. METHODS: Child-parent dyads were recruited for a multicentre randomized crossover trial. Children with T1D were current intermittently scanned CGM (isCGM) users and aged 2-13 years. Families received either 6 weeks of DIY RT-CGM with parental remote monitoring (intervention) or 6 weeks of isCGM plus usual diabetes care (control), followed by a 4-week washout period, then crossed over. The primary outcome was parental FOH. Secondary outcomes were glycemic control using traditional CGM metrics, as well as a range of other psychosocial measures. FINDINGS: Fifty five child-parent dyads were recruited. The child mean age was 9.1 ± 2.8 years. Although, there was no effect on parental FOH, -0.1 (95%CI: -0.3, 0.1, p = 0.4), time-in-range (TIR) (%3.9-10 mmol/L) was significantly higher with DIY RT-CGM over isCGM (54.3% ± 13.7 vs. 48.1% ± 13.6), mean difference, 5.7% (95%CI 1.8, 9.6, p <0.004). There was no difference for time spent in hypoglycemia. Parent diabetes treatment satisfaction was significantly higher following DIY RT-CGM compared to isCGM, mean difference 5.3 (95%CI: 2.3, 8.2, p <0.001). CONCLUSION: The use of DIY RT-CGM versus isCGM did not improve parental FOH; however, TIR and parental satisfaction with diabetes treatment were significantly improved. This suggests in the short term, DIY RT-CGM appears safe and may offer families some clinically important advantages over isCGM.

Emergency Glucagon: a Focused Review of Psychosocial Experiences of Rescue Drugs for Type 1 Diabetes.

PURPOSE OF REVIEW: The purpose of this paper is to describe rescue glucagon types, safety, efficacy, and preferences, as well as to review articles regarding emergency glucagon usage, severe hypoglycemia, and the emotions of both phenomena. We conducted a review of current literature on glucagon usage and the emotional impact of severe hypoglycemia on people with diabetes (PwD) and the caregivers of people with type 1 diabetes (T1D). RECENT FINDINGS: Minimal research exists pertaining to glucagon and severe hypoglycemic experiences in PwD, which is troubling considering the severity of risks and possible side effects. Recent articles described negative emotions such as fear, anxiety, stress, helplessness, shame, embarrassment, loneliness, frustration, hopefulness, and uncertainty surrounding glucagon usage. There is scarce research regarding PwD's emotions surrounding severe hypoglycemia and rescue glucagon use. Additional research is needed to investigate the emotions and feelings people with T1D and their caregivers' experience pertaining to severe hypoglycemia and emergency glucagon use.

The impact of hypoglycaemia in children and adolescents with type 1 diabetes on parental quality of life and related outcomes: A systematic review.

This systematic review aims to summarize and critically evaluate the current evidence regarding the impact of hypoglycaemia in children and adolescents with type 1 diabetes on parental quality of life. MEDLINE, PsycINFO, CINAHL, and the Cochrane Library were searched. Inclusion criteria were: 1) quantitative design, 2) included parents of children or adolescents with type 1 diabetes, 3) assessment of hypoglycemia in children/adolescents with type 1 diabetes, 4) assessment of parent quality of life (or related domains of life), and 5) analysis of the relationship(s) between the child's hypoglycaemia and parents' quality of life. The data were summarised in accordance with Synthesis Without Meta-Analysis Guidelines. Twelve studies were included, reporting data from 1895 parents across six countries. Ten studies were cross-sectional; two included prospective data. Evidence suggested that greater frequency and severity of hypoglycemia was associated with greater parental fear of hypoglycemia, emotional distress and family burden. Children's hypoglycaemia has a negative impact on the well-being of parents, but there is an absence of evidence regarding the impact on their overall quality of life. Research into the hypoglycaemia-specific quality of life of parents is needed to explore the impact on various areas, such as social and physical dimensions.

Conversations and reactions around severe hypoglycemia (CRASH) global survey of people with type 1 diabetes or insulin-treated type 2 diabetes and caregivers: Findings from the French cohort.

AIM: The objective of the CRASH (Conversations and Reactions Around Severe Hypoglycemia) survey was to further our understanding of the characteristics, experience, behavior and conversations with healthcare professionals (HCPs) of people with diabetes (PWD) receiving insulin, and of caregivers (CGs) caring for such people, concerning hypoglycemia requiring external assistance (severe hypoglycemic events [SHEs]). METHODS: CRASH was an online cross-sectional survey conducted across eight countries. PWD with self-reported type 1 (T1D) or insulin-treated type 2 (T2D) diabetes were aged≥18 years and had experienced one or more SHEs in the past 3 years; CGs were non-medical professionals aged ≥18 years, caring for PWD meeting all the above criteria except for PWD age (≥4 rather than ≥18 years). The present report is a descriptive analysis of data from France. RESULTS: Among PWD who had ever discussed SHEs with an HCP, 38.9% of T1D PWD and 50.0% of T2D PWD reported that SHEs were discussed at every consultation; 26.3% and 8.8%, respectively, had not discussed the most recent SHE with an HCP. In total, 35.7% of T1D PWD and 53.8% of T2D PWD reported that glucagon was not available to them at the time of their most recent SHE. Only 16.9% of T1D PWD and 6.5% of T2D PWD who had discussed their most recent SHE with an HCP reported that the HCP recommended obtaining a glucagon kit or asked them to confirm that they already had one. High proportions of PWD and CGs reported that the most recent SHE had made them feel unprepared, scared and helpless and had affected mood, emotional state and activities. CONCLUSION: CRASH survey data from France identify a need for greater discussion about SHEs between HCPs and PWD and the CGs of such people, and reveal gaps in the diabetes education of PWDs and CGs.

Changes in quality of life following hypoglycaemia in adults with type 2 diabetes: A systematic review of longitudinal studies.

AIM: To conduct a systematic review of published studies reporting on the longitudinal impacts of hypoglycaemia on quality of life (QoL) in adults with type 2 diabetes. METHOD: Database searches with no restrictions by language or date were conducted in MEDLINE, Cochrane Library, CINAHL and PsycINFO. Studies were included for review if they used a longitudinal design (e.g. cohort studies, randomised controlled trials) and reported on the association between hypoglycaemia and changes over time in patient-reported outcomes related to QoL. RESULTS: In all, 20 longitudinal studies published between 1998 and 2020, representing 50,429 adults with type 2 diabetes, were selected for review. A descriptive synthesis following Synthesis Without Meta-analysis guidelines indicated that self-treated symptomatic hypoglycaemia was followed by impairments in daily functioning along with elevated symptoms of generalised anxiety, diabetes distress and fear of hypoglycaemia. Severe hypoglycaemic events were associated with reduced confidence in diabetes self-management and lower ratings of perceived health over time. Frequent hypoglycaemia was followed by reduced energy levels and diminished emotional well-being. There was insufficient evidence, however, to conclude that hypoglycaemia impacted sleep quality, depressive symptoms, general mood, social support or overall diabetes-specific QoL. CONCLUSIONS: Longitudinal evidence in this review suggests hypoglycaemia is a common occurrence among adults with type 2 diabetes that impacts key facets in the physical and psychological domains of QoL. Nonetheless, additional longitudinal research is needed-in particular, studies targeting diverse forms of hypoglycaemia, more varied facets of QoL and outcomes assessed using hypoglycaemia-specific measures.

Fear of hypoglycemia in children with type 1 diabetes and their parents: Validation of the Italian version of the Hypoglycemia Fear Survey for Children and for Parents.

BACKGROUND: Currently, Italian versions of the Hypoglycemia Fear Survey for Children (CHFS) and for Parents (PHFS) quantifying Fear of Hypoglycemia (FoH) in pediatric diabetes are not available. OBJECTIVE: To validate the Italian version of the CHFS and PHFS. SUBJECTS AND METHODS: One hundred and seventy-four children with type 1 diabetes aged 6-18 and 178 parents completed the CHFS and PHFS, the PedsQL 3.0 Diabetes module and the KIDSCREEN-10. Internal consistency was good (α = 0.85 for CHFS, α = 0.88 for PHFS); validity was supported by correlations of CHFS total score (CHFS-T r = -0.50; p < 0.001, CI = -0.62 to -0.35) and Worry subscale (CHFS-W r = -0.49; p < 0.001, CI = -0.62 to -0.32) with measures of health-related quality of life (QoL), which were not related to PHFS scores. Factor analyses justified the structure and the separate scoring of Behavior and Worry subscales. Children's age was negatively correlated with CHFS-T (r = -0.16; p = 0.03, CI = -0.36 to 0.00), CHFS-W (r = -0.29; p = 0.02, CI = -0.39 to -0.07), PHFS-T (r = -0.20; p = 0.006, CI = -0.35 to -0.04), PHFS-B (r = -0.30; p = 0.001, CI = -0.43 to -0.17). Mean (SD) item scores of CHFS-T (1.47 ± 0.56 vs. 1.27 ± 0.57; p < 0.05) and CHFS-W (1.20 ± 0.73 vs. 0.96 ± 0.68; p < 0.05) were higher in children with HbA1c ≥7.5%. Higher levels of distress for upsetting hypoglycemia were associated with lower child's QoL scores as perceived by children (Peds-QL: 72.6 ± 12.8 vs. 80.4 ± 11.9; p < 0.001) and parents (Peds-QL: 70.6 ± 13.8 vs. 75.8 ± 12.9; p < 0.05). CONCLUSION: The Italian version of CHFS and PHFS appears to be a valid measure to assess FoH in clinical practice and factor analysis supports separate scoring for the Worry and Behavior subscales.