Hypoglycemia Fear Survey Research Articles

THE RELATIONSHIP BETWEEN HYPOGLYCEMIC CONFIDENCE AND HYPOGLYCEMIA FEAR IN TYPE 2 DIABETES MELLITUS PATIENTS

Objective: This study aims to identify the relationship between hypoglycemic confidence and hypoglycemia fear in type 2 diabetes mellitus patients.
 Method: Designed as a descriptive and cross-sectional study, this research was conducted with 306 type 2 diabetes patients who visited the diabetes polyclinic to have an examination in period December 2021 and February 2022. The research data were collected by using the “Patient Identification Form”, the “Hypoglycemic Confidence Scale”, and the “Hypoglycemia Fear Survey”. Descriptive statistics, the Independent Samples t-test, the One-Way ANOWA test, the Pearson’s correlation test, and the linear regression analysis were used in the evaluation of research data.
 Results: In the research, 60.8% of the participant type 2 diabetes patients were female, their mean age was 55.14±8.10 years, and their mean duration of having the disease was 10.35±4.77 years. Means of type 2 diabetes patients’ Hypoglycemic Confidence Scale (HCS)’ score 1.65±0.47 and ‘Hypoglycemia Fear Survey (HFS)’ scores were 3.02±0.56 points. Type 2 diabetes patients’ HCS scores had moderately negative relationships with scores obtained by them from the HFS and its Behavior Sub-scale and Worry Sub-scale (p

Fear of hypoglycemia and quality of life in young people with type 1 diabetes and their parents in the era of sensor glucose monitoring.

IntroductionIt is crucial to understand psychosocial outcomes in children and adolescents with type 1 diabetes (T1D) and their families to provide optimal family-centered care. Hence, the aim of this study was to explore psychosocial outcomes in young people with T1D and their parents using currently available glucose monitoring devices in a real-life clinic setting.MethodsChildren and adolescents aged 2-18 years with T1D for more than 6 months and their parents were recruited into a cross-sectional study to complete the Hypoglycemia Fear Survey (HFS) and the Pediatric Quality of Life Inventory (PedsQL) Generic Score Scales, Diabetes Module and Family Impact Module. Demographics and diabetes-specific parameters were obtained from medicals records.ResultsFifty-nine children and adolescents (mean age 15.1 ± 3.0 years) and 49 parents of children (mean age of children 12.5± 3.3 years) of which 44 were child-parent dyads completed the questionnaires. Parents had a higher mean (SD) FOH total and worry subscore than children, total score was 37.9 (14.6) vs. 32.2 (11.9), p = 0.047 and worry subscore was 17.8 (10.4) vs. 12.8 (9.0), p = 0.01. Furthermore, lower parental diabetes-specific QoL score was observed in parents, 78.8 (12.2) vs. 82.7 (10.3), p=0.02. No difference in FOH and QoL between real-time continuous glucose monitoring (rtCGM) and intermittently scanned glucose monitoring (isCGM) users and users of devices with and without alerts was observed. In isCGM users (n=36 completing the child questionnaires, n=33 completing parent questionnaires), higher parental FOH and lower parental diabetes-specific QoL correlated with higher scanning frequency, r = 0.399, p = 0.021, and r = -0.464, p = 0.007 respectively. No significant correlation was documented between scanning frequency and child questionnaire scores.ConclusionsParents are more likely to perceive higher levels of psychosocial burden related to their child’s diabetes than children and adolescents with T1D, especially parents of younger children. This highlights the need for family-based education and treatment resources to support parents in diabetes management in addition to rapidly advancing diabetes technology. In isCGM users, higher parental FOH and lower parent-perceived QoL correlated with a higher scanning frequency, indicating the potential impact of glucose monitoring modality on psychosocial outcomes or vice versa.

Household Food Insecurity and Fear of Hypoglycemia in Adolescents and Young Adults With Diabetes and Parents of Youth With Diabetes.

To evaluate the relation between household food insecurity (HFI) and fear of hypoglycemia among young adults with type 1 and type 2 diabetes and adolescents with type 1 diabetes and their parents. We analyzed cross-sectional data of 1,676 young adults with youth-onset diabetes (84% type 1, 16% type 2) and 568 adolescents (<18 years old; mean age 15.1 years) with type 1 diabetes from the SEARCH for Diabetes in Youth study. Adult participants and parents of adolescent participants completed the U.S. Household Food Security Survey Module. Adults, adolescents, and parents of adolescents completed the Hypoglycemia Fear Survey, where answers range from 1 to 4. The outcomes were mean score for fear of hypoglycemia and the behavior and worry subscale scores. Linear regression models identified associations between HFI and fear of hypoglycemia scores. Adults with type 1 diabetes experiencing HFI had higher fear of hypoglycemia scores (0.22 units higher for behavior, 0.55 units for worry, 0.40 units for total; all P < 0.0001) than those without HFI. No differences by HFI status were found for adolescents with type 1 diabetes. Parents of adolescents reporting HFI had a 0.18 unit higher worry score than those not reporting HFI (P < 0.05). Adults with type 2 diabetes experiencing HFI had higher fear of hypoglycemia scores (0.19 units higher for behavior, 0.35 units for worry, 0.28 units for total; all P < 0.05) than those in food secure households. Screening for HFI and fear of hypoglycemia among people with diabetes can help providers tailor diabetes education for those who have HFI and therefore fear hypoglycemia.

770-P: Treatment Satisfaction and Fear of Hypoglycemia in the ADAPT Study: A Six-Month, Randomized Controlled Trial Comparing an Advanced Hybrid Closed-Loop System to Multiple Daily Injections (MDI) with Intermittently Scanned CGM (isCGM)

Objective: To assess the effect of the MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system compared to MDI with isCGM (MDI+isCGM) therapy on treatment satisfaction (TS) and fear of hypoglycemia (FoH) , in adults with type 1 diabetes (T1D) with above-target baseline glycemic control participating in the ADAPT study. Methods: Participants with T1D who were on MDI+isCGM and who had suboptimal glycemic control (HbA1c≥8%) were randomly assigned to AHCL or to continue MDI+isCGM. Treatment satisfaction was measured with the Diabetes-Treatment-Satisfaction-Questionnaire, status (DTSQs) and change (DTSQc) and FoH with the Hypoglycemia Fear Survey (HFS) . Results: Overall, the decrease in HbA1c was 1.4% greater in the AHCL group vs. MDI+isCGM group (P&amp;lt;0.001) with no difference in hypoglycemia. Mean DTSQs score increased significantly in the AHCL arm after 6 months compared to the MDI+isCGM arm (29.7 vs. 21.9, P=0.0003) , with significant improvement in perceived frequency of hyperglycemia (P&amp;lt;0.001) . There was no difference in the perceived frequency of hypoglycemia. Results were consistent in both DTSQs and DTSQc. Fear of hypoglycemia decreased in both groups, but the decrease was significantly greater in the AHCL group. At 6 months, HFS scores decreased by 10.2 points and 2.7 points from baseline in the AHCL and MDI+isCGM groups, respectively (P=0.04) . Conclusion: AHCL therapy improves patient-reported outcomes with greater treatment satisfaction and reduced FoH compared to MDI+isCGM in sub-optimally controlled participants with T1D. Disclosure S.De portu: Employee; Medtronic. J.Castañeda: Employee; Medtronic. O.Cohen: Employee; Medtronic. Adapt study group: n/a. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker's Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. J.Kroeger: Advisory Panel; Abbott Diabetes, Dexcom, Inc., Other Relationship; AstraZeneca, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck Sharp &amp; Dohme Corp., Novo Nordisk, Sanofi-Aventis Deutschland GmbH, Tandem Diabetes Care, Inc., Research Support; Medtronic. C.Thivolet: Board Member; Insulet Corporation, Medtronic, Research Support; Abbott Diabetes, Lilly Diabetes, Novo Nordisk A/S, Sanofi. M.Evans: Advisory Panel; Pila Pharma, Zucara Therapeutics, Other Relationship; Abbott Diabetes, Dexcom, Inc., Medtronic, Novo Nordisk, Research Support; AstraZeneca, Sanofi, Speaker's Bureau; Lilly Diabetes. R.Ré: Employee; Medtronic. L.Vorrink de groot: Employee; Medtronic. J.Shin: Employee; Medtronic. A.Habteab ghebretinsae: None. Funding Medtronic

596-P: Diabetes Responsibility Moderates Relationship between Fear of Hypoglycemia and A1C in Adolescents with Type 1 Diabetes

Fear of hypoglycemia (FOH) is not consistently correlated with A1C in youth with T1D, but few studies have taken other psychosocial variables into account. This study examined T1D responsibility as a moderator of the relationship between FOH and A1C. N=1youth ages 10-18 yrs (45.5% male; age=14.7±1.9 yrs; A1C=9.9±1.6%; T1D duration=6.5+3.4 yrs) completed the Maintain High Blood Glucose subscale of the Children’s Hypoglycemia Fear Survey (assesses behavioral manifestations of FOH) and Diabetes Family Responsibility Questionnaire (assesses distribution of T1D responsibility between child and caregiver) . Higher scores indicate greater FOH and caregiver responsibility, respectively. The main effect of T1D responsibility on A1C was not significant (p&amp;gt;0.05) , whereas the main effect of Maintain High Blood Glucose was (p=0.03) . Responsibility moderated the relationship between Maintain High Blood Glucose and A1C; child’s FOH had less of an effect on A1C if the caregiver had higher responsibility (B=-0.41, p=0.04; R2 =0.038, p&amp;lt;0.04) . Children who maintain their blood glucoses higher than recommended due to high FOH should have more parent involvement in their T1D care to minimize the deleterious impact of their fears on A1C. Future research should examine the Maintain High Blood Glucose subscale and other psychosocial moderators specifically in relation to glycemic outcomes. Disclosure E.R.Shaffer: None. H.K.O'donnell: None. G.T.Alonso: None. S.Majidi: None. J.K.Snell-bergeon: Stock/Shareholder; GlaxoSmithKline plc. R.Wadwa: Advisory Panel; Dompé, Consultant; Beta Bionics, Inc., Other Relationship; Tandem Diabetes Care, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care, Inc. K.A.Driscoll: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (DP3DK113363)

646-P: Sustained Impact of Switching from Intermittently Scanned to Real-Time Continuous Glucose Monitoring in Adults with Type 1Diabetes: 24-Month Results of the ALERTT1 Trial

Background: The 6-month multicenter randomized controlled ALERTT1 trial showed improvement of time in range (TIR; 70-180 mg/dL) , HbA1c, time &amp;lt;54 mg/dL and fear of hypoglycemia in adults with type 1 diabetes (T1D) switching from intermittently scanned continuous glucose monitoring (isCGM; FreeStyle Libre 1) to real-time CGM (rtCGM; Dexcom G6) . It is unclear whether these benefits are sustained in the long term. Methods: In this partial cross-over extension trial, the control group (n=127) switched as planned from isCGM to rtCGM from month 6 to month 24. The experimental group (n=127) continued rtCGM until month 24. Primary outcome was TIR. Key secondary outcomes were HbA1c, time &amp;lt;54 mg/dL and Hypoglycemia Fear Survey worry (HFS-worry) score. Within-group change (Δ) vs. start of rtCGM is reported (mean [95% CI]) . Results: People in the trial were on average 42.9 years old; mean HbA1c was 7.4%. A minority used an insulin pump (n=49) or were hypo unaware (n=44) . TIR increased from 51.8% to 63.5% at month 12 in the former isCGM group (Δ 11.7% [9.6-13.8] P&amp;lt;0.0001) and remained stable up to month 24 (Δ 11.7% [9.4-14.0] P&amp;lt;0.0001) . In the former rtCGM group, TIR increased from 52.5% to 63.0% at month 12 (Δ 10.6% [8.4-12.8] P&amp;lt;0.0001) and remained stable up to month 24 (Δ 10.5% [8.2-12.8] P&amp;lt;0.0001) . HbA1c decreased to 6.9% (Δ -0.54%; P&amp;lt;0.0001) and 7.0% (Δ -0.43%; P&amp;lt;0.0001) at month 24 in the former isCGM and rtCGM group respectively, together with a decrease of -2.67 points (P=0.0008) and -5.17 points (P&amp;lt;0.0001) in HFS-worry score. No significant reduction in time &amp;lt;54 mg/dL was seen after month 12. Percentage of people achieving the TIR consensus target increased from 14.9% to 37.8% (P&amp;lt;0.0001) in the former isCGM group and from 13.4% to 41.4% (P&amp;lt;0.0001) in the former rtCGM group. Conclusion: In adults with T1D, switching from isCGM to rtCGM is beneficial up to 24 months, adding further evidence that rtCGM with alerts is superior to isCGM without alerts. Disclosure M.M.Visser: Other Relationship; Boehringer Ingelheim International GmbH, Dexcom, Inc., Dexcom, Inc., Novo Nordisk. N.Myngheer: Advisory Panel; AstraZeneca, Speaker's Bureau; AstraZeneca, Novo Nordisk. C.F.Vercammen: Other Relationship; AstraZeneca. F.Nobels: Advisory Panel; Abbott Diabetes, AstraZeneca. B.Keymeulen: None. C.Mathieu: Advisory Panel; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Imcyse, Insulet Corporation, Medtronic, Novo Nordisk, Sanofi, Zealand Pharma A/S, Speaker's Bureau; AstraZeneca. P.Gillard: Advisory Panel; Bayer AG, Novo Nordisk, Speaker's Bureau; Abbott Diabetes, Bayer AG, Dexcom, Inc., Insulet Corporation, Medtronic, Novo Nordisk, Roche Diabetes Care, Sanofi. S.Charleer: None. S.Fieuws: None. C.De block: Advisory Panel; Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Novo Nordisk, Research Support; Indigo Diabetes, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk. R.Hilbrands: None. L.Van huffel: Advisory Panel; Roche Diagnostics, Other Relationship; Medtronic, Speaker's Bureau; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim International GmbH, Merck Sharp &amp; Dohme Corp., Novo Nordisk. T.Maes: None. G.Vanhaverbeke: Advisory Panel; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck Sharp &amp; Dohme Corp., Speaker's Bureau; Novo Nordisk, Sanofi. E.L.Dirinck: None. Funding Dexcom, San Diego, CA, USA (OUS-2018-011)

7-LB: Gender Differences in Reported Consequences of Level 2 and Level 3 Hypoglycemia among Adults Living with Type 1 Diabetes—A BETTER Registry Analysis

Introduction: Hypoglycemia is a common side effect of type 1 diabetes (T1D) therapy with consequences ranging from physical and cognitive impairment to reduced quality of life. Studies evaluating consequences of level 2 (L2H, glucose level&amp;lt;3.0mmol/L without needing assistance from another person to recover) and level 3 (L3H, needing assistance from another person) hypoglycemia between the genders are sparse. Aim: To highlight the differences in reported consequences related to both L2H and L3H between genders. Methods: Self-reported data from an online Canadian registry of adults with T1D were analyzed using logistic regression models adjusted for age, diabetes technology use, hypoglycemia history in the past month, Hypoglycemia Fear Survey II (HFS II) , and Hypoglycemia Confidence Scale (HCS) scores. Results: Among 877 adults (65% women, mean age 43 ± 15 years, mean duration of T1D 25 ± 15 years, 34% reported a HbA1c ≤ 7.0%, 81% used continuous glucose monitoring, and 43% used an insulin pump) , 15% experienced L3H in the past year and 81% experienced L2H in the past month. Women reported more L2H (84% vs. 75%, p=0.004) and worse HFS-II and HCS scores than men (median 33 [IQR 23, 47] vs. 28 [18, 38], p=0.002 and 3.2 [2.9, 3.6] vs. 3.4 [3.0, 3.8], p&amp;lt;0.001, respectively) . The adjusted regression models showed that women were more likely than men to report experiencing persistent fatigue after L2H (OR 1.76, 95%CI [1.19, 2.61]) and increased anxiety, persistent fatigue, or an additional encounter with a healthcare professional after a L3H episode (1.71 [1.04, 2.82]; 1.75 [1.02, 3.00]; 2.59 [1.17, 5.74], respectively) . Conclusion: Women report significantly more L2H and L3H consequences compared to men, in addition to reporting higher fear and lower confidence. Social constructs on stress management may explain the observed gender differences, and suggest taking a gender-based differential approach when addressing hypoglycemia. Disclosure M. K. Talbo: None. M. Lebbar: None. V. Messier: None. Z. Wu: Other Relationship; Eli Lilly and Company. A. Brazeau: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi. R. Rabasa-lhoret: Consultant; HLS Therapeutics Inc., Pfizer Inc., Other Relationship; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., Medtronic, Merck &amp; Co., Inc., Novo Nordisk Canada Inc., Sanofi, Vertex Pharmaceuticals Incorporated, Research Support; Canadian Institutes of Health Research, Cystic Fibrosis Canada, Diabetes Canada, Fondation Francophone pour la Recherche en Diabète (FFRD) , JDRF, National Institutes of Health, Société Francophone du Diabète (SFD) , Speaker’s Bureau; Canadian Medical &amp; Surgical Knowledge Translation Research Group (CMS) , CPD Network, Tandem Diabetes Care, Inc. Funding Canadian Institutes of Health Research (JT1-157204) and Juvenile Diabetes Research Foundation (4-SRA-2018-651-Q-R)

657-P: Frequency Scanning Correlates Not Only with Glycemic Indices but Also with Fear of Hypoglycemia in Type 1 Diabetes Patients Using is-CGMS

Frequency scanning with intermittently scanned CGMS (is-CGMS) is associated with glycemic indices. No data is available for its correlation with fear of hypoglycemia (FOH) , a well-known factor affecting quality of life and glycemic control in type 1 diabetes (T1DM) . The aim of the study was to analyze the association of scanning frequency with glycemic indices and FOH in T1DM patients using is-CGMS. T1DM patients using is-CGMS were eligible. Clinical data, Ambulatory Glucose Profile (AGP) reports were obtained from medical records. FOH was assessed using Hypoglycemia Fear Survey II (HFS-II) . We included 77 consecutive patients (58 females) , 38 were treated with insulin pump, 39 with multiple daily injections. Their mean age was 34.1+/-10.2 years and T1DM duration 14.7 +/-12.0 years. Mean glycemic indices were as follows: mean glucose - 155.8+/-29.8 mg/dl; GMI - 53.3+/-7.5 mmol/mol; TIR - 66.4+/-17.8%; TB70 - 4.5+/-4.1%; TB54 - 0.6+/-1.2%; TA180 - 29.2 +/-17.9%; TA250 - 9.6+/-10.4%; %CV - 36.7+/-8.3. The average scanning frequency was 13.8+/-7.8 scans/d. Mean HFS II scores were 16.1+/-7.2 and 18.7+/-12.2 in behavior and worry subscale, respectively. Correlation was found between scanning frequency and mean glucose, GMI, TIR, TB70, TA180, TA250, %CV and HFS-B (p&amp;lt;0.for all statistics) . In summary, for the first time, we report that higher scanning frequency is associated not only with better glycemic indices but also with less FOH in T1DM patients using is-CGMS. This constitutes a new argument for advising T1DM patients frequent scanning when using is-CGMS. Disclosure J.Hohendorff: Advisory Panel; Abbott. M.Malecki: Consultant; Abbott Diabetes, Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk, Speaker's Bureau; Ascensia Diabetes Care, AstraZeneca, Bayer AG, Merck &amp; Co., Inc., Mundipharma, Servier Laboratories. P.W.Witek: Other Relationship; Abbott, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Medtronic, Merck &amp; Co., Inc., Novo Nordisk, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH. M.Kania: None. M.Sudol: None. K.Hajduk: None. A.Stepien: None. K.Cyganek: Speaker's Bureau; Abbott Diabetes, Ascensia Diabetes Care, Bausch Health, Canada, Boehringer Ingelheim International GmbH, Lilly Diabetes, Medtronic, Novo Nordisk, Roche Diabetes Care. B.Kiec-wilk: n/a. T.Klupa: Advisory Panel; Abbott, BIOTON S.A., Sanofi, Research Support; Medtronic, Speaker's Bureau; Ascensia Diabetes Care, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk.

39-OR: Improved Psychosocial and Quality of Life Measures in Children and Youth with Type 1 Diabetes Initiating Control-IQ Technology

Objective: To determine perceptions of the impact of Control-IQ™ technology (CIQ) on psychosocial functioning and quality of life (QoL) in children/ youth with T1D and their parents, using patient and parent reported outcome measures (PROMs) . Research Design and Methods: Single-center prospective real-world study of 6-18 year olds with T1D using the t:slim X2™ insulin pump, who were initiating CIQ. Youth (≥ 8years) and parents completed validated PROMs at baseline and end of study (16 weeks) . INSPIRE (INsulin delivery Systems: Perceptions, Ideas, Reflections and Expectations) end of study scores were the primary outcome with a score &amp;gt; 60 considered to indicate a perceived benefit of CIQ on psychosocial functioning and QoL. Glycemic control measures were recorded at baseline and every 4 weeks. Results: In total, 65 children/youth with T1D participated; 50.8% female, median (IQR) age 13.9 (11.1, 15.7) years and T1D duration 6.2 (3.1, 8.4) years. INSPIRE end of study mean (SD) scores were 73.0 (11.6) for youth (n=49) and 70.7 (12.2) for parents (n=45) , both significantly &amp;gt; 60 (p &amp;lt; 0.001) . Diabetes Impact and Devices Satisfaction - Device Satisfaction subscale score increased by a mean (95% CI) of 0.43 (0.11, 0.74) in youth (p = 0.01) and 0.58 (0.31, 0.85) in parents (p&amp;lt;0.001) . WHO-5 well-being index median (IQR) score increased from 60 (48, 76) to 72 (60, 80) (p=0.25) in youth, and from 68 (55, 76) to 76 (68, 80) (p=0.002) in parents. Hypoglycemia Fear Survey mean (SD) score improved from 1.7 (0.6) to 1.4 (0.5) (p=0.01) in youth and from 2.0 (0.7) to 1.7 (0.6) (p&amp;lt;0.001) in parents. Time in range improved from 50.8% (baseline) to 62.2% (4 weeks) , with mean difference (95% CI) 9.62 (7.01, 12.23) , p&amp;lt;0.001; this was sustained to 16 weeks. Conclusions: Initiation of CIQ in a real-world setting significantly improved measures of psychosocial functioning and QoL in children/youth with T1D and their parents. The change tended to be greater for parents than youth. Disclosure C.S.Zuijdwijk: Other Relationship; Medtronic, Research Support; Tandem Diabetes Care, Inc. J.Courtney: None. N.Mitsakakis: None. L.Hayawi: None. S.E.Lawrence: Advisory Panel; Pfizer Inc., Research Support; Tandem Diabetes Care, Inc. Funding Tandem Diabetes Care

1017-P: Relationship between Parent Fear of Hypoglycemia and Diabetes Family Conflict in Adolescents with Type 1 Diabetes

Few studies have examined the relationship between diabetes-related family conflict and parent fear of hypoglycemia (FOH) in adolescents, thus the current research evaluated this connection. This study specifically examined three subdimensions of FOH which parents of children with diabetes may experience: maintaining blood glucoses higher than medical recommendations, worrying about and/or feeling helplessness about preventing low blood glucoses, and worrying about social consequences associated with low blood glucoses. At the baseline visit of an RCT aimed at improving health outcomes of youth with elevated A1C (9-12% in the last year) , caregivers completed the Diabetes Family Conflict Scale and the Parent Hypoglycemia Fear Survey. N=1child-caregivers dyads (child age=14.7±1.9 years, T1D duration=6.5±3.4 years, A1C=9.9±1.6%; 53% female; 77% continuous glucose monitor; 82% insulin pump) . In three separate regression models, no child demographic or T1D clinical characteristics other than A1C were associated with family conflict. After controlling for A1C, only Worry/Helplessness About Low Blood Glucose (b=0.182; p=0.025) and Worry About Negative Social Consequences (b=0.532; p=0.008) significantly predicted parent-reported family conflict; Maintain High Blood Glucose (b=0.082; p=0.73) was not significant. This is the first study to demonstrate that caregivers’ worry about their adolescents having low blood glucoses is associated with diabetes-specific family conflict- a common adherence barrier for adolescents with T1D and their families. This finding supports screening caregivers for fear of hypoglycemia and incorporating into treatment when providing intervention for families with high levels of conflict. Important next steps include dyadic data analysis to understand how fear of hypoglycemia symptoms among child-caregiver dyads affect family conflict. Disclosure H.Manis: Other Relationship; Abbott Diabetes. H.K.O'donnell: None. G.T.Alonso: None. S.Majidi: None. J.K.Snell-bergeon: Stock/Shareholder; GlaxoSmithKline plc. R.Wadwa: Advisory Panel; Dompé, Consultant; Beta Bionics, Inc., Other Relationship; Tandem Diabetes Care, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Tandem Diabetes Care, Inc. K.A.Driscoll: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (DP3DK113363)

Real-world prospective observational single-centre study: Hybrid closed loop improves HbA1c, time-in-range and quality of life for children, young people and their carers.

Hybrid closed-loop (HCL) systems are characterised by integrating continuous glucose monitoring (CGM) with insulin pumps which automate insulin delivery via specific algorithms and user-initiated insulin delivery.The aim of the study was to evaluate the effectiveness of HCLs on Hba1c, time-in-range (TIR), time in hypoglycaemia, fear of hypoglycaemia, sleep and quality of life measure in children and young people (CYP) with T1D and their carers. Data on HbA1c, TIR and hypoglycaemia frequency were reviewed at baseline prior to starting HCL and 3months after commencement. As part of clinical care, all patients and carers were provided with key education on the use of the HCL system by trained diabetes healthcare professionals. CYP aged 12years and above independently completed the validated Hypoglycaemia Fear Survey (HFS). Parents of patients <12 were asked to complete a modified version of the HFS-Parent (HFS-P) survey. There were 39 CYP (22men) with T1D included with a mean age of 11.8±4.4 at commencement of HCL. Median duration of diabetes was 3.8years (interquartile range 1.3-6.0). There were 55% of patients who were prepubertal at the time of HCL commencement. 91% were on the Control-IQ system and 9% on the CamAPS FX system. HCL use demonstrated significant improvements at 3months in the following: HbA1c in mmol/mol (63.0 vs. 56.6, p=0.03), TIR (50.5 vs. 67.0, p=0.001) and time in hypoglycaemia (4.3% vs. 2.8%, p=0.004). HFS scores showed improved behaviour (34.0 vs. 27.5.9, p=0.02) and worry (40.2 vs. 31.6, p=0.03), and HFS-P scores also showed improved behaviour (p<0.001) and worry (p=0.01). Our study shows that HCL at 3months improves glucose control, diabetes management and quality of life measures such as fear and worry of hypoglycaemia for CYP and carers.

Characteristics of adults with type 1 diabetes and treatment-resistant problematic hypoglycaemia: a baseline analysis from the HARPdoc RCT

Aims/hypothesisProblematic hypoglycaemia still complicates insulin therapy for some with type 1 diabetes. This study describes baseline emotional, cognitive and behavioural characteristics in participants in the HARPdoc trial, which evaluates a novel intervention for treatment-resistant problematic hypoglycaemia.MethodsWe documented a cross-sectional baseline description of 99 adults with type 1 diabetes and problematic hypoglycaemia despite structured education in flexible insulin therapy. The following measures were included: Hypoglycaemia Fear Survey II (HFS-II); Attitudes to Awareness of Hypoglycaemia questionnaire (A2A); Hospital Anxiety and Depression Index; and Problem Areas In Diabetes. k-mean cluster analysis was applied to HFS-II and A2A factors. Data were compared with a peer group without problematic hypoglycaemia, propensity-matched for age, sex and diabetes duration (n = 81).ResultsThe HARPdoc cohort had long-duration diabetes (mean ± SD 35.8 ± 15.4 years), mean ± SD Gold score 5.3 ± 1.2 and a median (IQR) of 5.0 (2.0–12.0) severe hypoglycaemia episodes in the previous year. Most individuals had been offered technology and 49.5% screened positive for anxiety (35.0% for depression and 31.3% for high diabetes distress). The cohort segregated into two clusters: in one (n = 68), people endorsed A2A cognitive barriers to hypoglycaemia avoidance, with low fear on HFS-II factors; in the other (n = 29), A2A factor scores were low and HFS-II high. Anxiety and depression scores were significantly lower in the comparator group.Conclusions/interpretationThe HARPdoc protocol successfully recruited people with treatment-resistant problematic hypoglycaemia. The participants had high anxiety and depression. Most of the cohort endorsed unhelpful health beliefs around hypoglycaemia, with low fear of hypoglycaemia, a combination that may contribute to persistence of problematic hypoglycaemia and may be a target for adjunctive psychological therapies.Graphical abstract

Improvements in Parental Sleep, Fear of Hypoglycemia, and Diabetes Distress With Use of an Advanced Hybrid Closed-Loop System.

Parental sleep quality may contribute to glycemic control in youth with type 1 diabetes. In this article we present sleep analysis from a multicenter, randomized trial of children ages 6-13 years with type 1 diabetes evaluating the Tandem Control-IQ (CIQ) hybrid closed-loop (HCL) system. Pittsburgh Sleep Quality Index (PSQI) scores were assessed at baseline to identify parents as "poor" sleepers (PSQI >5). Glycemic and psycho-behavioral outcomes before and after CIQ use were analyzed in poor sleepers (n = 49) and their children. Nocturnal time in range (P < 0.001) and time hyperglycemic (P < 0.001), Hypoglycemia Fear Survey for Parents score (P < 0.001), Problem Areas in Diabetes scale score (P < 0.001), PSQI score (P < 0.001), and Hypoglycemia Fear Survey for Children score (P = 0.025) significantly improved. Of poor sleepers, 27 became good sleepers (PSQI score <5). Use of CIQ in youth with type 1 diabetes ages 6-13 years significantly improved sleep and psychosocial measures in parent poor sleepers, coinciding with improvements in child nocturnal glycemia, highlighting the relationship between HCL systems and parent sleep quality.

Switching from predictive low glucose suspend to advanced hybrid closed loop control: Effects on glucose control and patient reported outcomes

AimsAutomated insulin delivery improves glucose control. Aim of this study was to compare in real life the effects on glucose control and patient reported outcomes of an advanced hybrid closed loop system (Control-IQ), versus a simpler system with predictive low glucose suspend function (Basal-IQ). MethodsThirty-one type 1 diabetic subjects were studied during Basal-IQ and after switching to Control-IQ. Variables analyzed were time spent in range (70–180 mg/dL), in tight range (70–140 mg/dL), above range (>180 mg/dL), below range (<70 mg/dL), mean glucose, coefficient of variation and glycated hemoglobin. Questionnaires were administered regarding therapy satisfaction (Diabetes Treatment Satisfaction Questionnaire in status/change form), fear of hypoglycemia (Hypoglycemia Fear Survey), quality of sleep (Pittsburgh Sleep Quality Index). ResultsAfter 12 weeks of Control-IQ, time in range increased from 62.7 to 74.0%, p < 0.0001, time in tight range increased from 37.1 to 44.6 %, p < 0.001, time above range decreased from 35.6 to 24.4% p < 0.0001. Improvements were observed in mean glucose and glucose variability. Glycated hemoglobin decreased from 7.0% (53 mmol/mol) to 6.6% (49 mmol/mol), p < 0.0001. Subjects using Control-IQ manifested greater satisfaction and less fear of hypoglycemia. ConclusionCompared to Basal-IQ, Control-IQ improves glucose control and therapy satisfaction.

A Cross-Sectional study on risk factors for severe hypoglycemia among Insulin-Treated elderly type 2 diabetes Mellitus (T2DM) patients in Singapore

ObjectiveThis study investigates the risk factors for severe hypoglycemia among Southeast Asian T2DM patients. MethodsInsulin-treated T2DM patients greater than 65 years old with HbA1c < 8% were recruited. They completed questionnaires detailing their experience of hypoglycemia and presence of impaired hypoglycemia awareness (IAH). Data on insulin treatment regimens, glycated haemoglobin (Hba1c) and comorbidities were also collected. ResultsOf the 92 participants, 15.2% had at least one episode of severe hypoglycemia over the past year. Comparison between both groups showed that patients with severe hypoglycemia had lower Hba1c, higher Gold score (3.9 ± 1.9 vs. 2.5 ± 1.4; p < .05) and higher Hypoglycemia Fear Survey (HFS) worry score (39.1 ± 14.3 vs. 31.8 ± 11.8; p < .05). There were no significant differences in duration of diabetes and insulin treatment, treatment regimens and diabetes associated comorbidities except peripheral vascular disease. Furthermore, no significant differences were noted in HFS behavior score, hypoglycemia risk modifying behavior and social economic status. ConclusionsPatients with severe hypoglycemia had tighter glycemic control, greater IAH and higher worry scores regardless of treatment regimens. Clinicians may play a significant role in tightening glycemic control and influencing the risk of severe hypoglycemia. Standard structured diabetes education may help reduce the risk of severe hypoglycemia among this group of patients.

Quality of life in people with type 2 diabetes in the 3 years following initiation of second-line therapy: The DISCOVER study

AimsTo assess changes in health-related quality of life (HRQoL) in DISCOVER, a 3-year, longitudinal, observational study of patients with type 2 diabetes initiating a second-line glucose-lowering therapy. MethodsHRQoL was assessed using the physical and mental component summary (PCS and MCS) scores of the 36-item Short-Form Health Survey version 2 (score ranges: 0–100; higher denotes better HRQoL) and the Hypoglycaemia Fear Survey II (HFS-II; score range: 0–132 scale; higher indicates greater fear of hypoglycaemia). Latent class growth modelling (LCGM) was used to identify patients with similar score trajectories. ResultsMean baseline PCS (n = 7428), MCS (n = 7453), and HFS-II (n = 5005) scores were 48.0, 45.4, and 15.4, respectively, and remained stable during follow-up. LCGM revealed subgroups with low or decreasing HRQoL. Patients in these subgroups tended to be older, had more comorbidities, and a lower socioeconomic status than in other subgroups. Use of insulin and sulfonylureas was highest in the subgroup with the highest fear of hypoglycaemia. ConclusionsOverall, HRQoL remained stable in DISCOVER patients during follow-up. However, LCGM suggests that some patient characteristics and use of sulfonylureas or insulin are associated with low or decreasing HRQoL, potentially warranting the use of alternative therapies.

Continuous Glucose Monitoring in Young Adults With Type 1 Diabetes: Impact on Hypoglycemia Confidence and Fear.

Fear of hypoglycemia in people with type 1 diabetes has a detrimental effect on glycemic control and quality of life. The association between continuous glucose monitoring (CGM) and hypoglycemia confidence and fear has not previously been assessed in the young adult population. This was a prospective cohort study using questionnaires to assess the impact of CGM on hypoglycemia confidence (using the Hypoglycemia Confidence Scale [HCS]) and hypoglycemia fear (using the Hypoglycemia Fear Survey II [HFS]) in 40 young adults with a preexisting diagnosis of type 1 diabetes. Scores on the HCS were greater at baseline for those with a longer duration of diabetes. Participants with higher general anxiety scores on the Generalized Anxiety Disorder 7-item scale had higher hypoglycemia fear at baseline (total score and worry component, but not behavior component of the HFS). Between baseline and follow-up, HCS scores increased on average by 0.2 (95% CI 0.1-0.4, P = 0.01) on a scale of 1-4. HFS scores decreased by 1.8 (95% CI -3.0 to -0.5, P = 0.006) on a scale of 0-24 for the worry component and by 2.5 (95% CI -4.4 to -0.6, P = 0.01) on a scale of 0-44 for total (worry + behavior components). At follow up, 83% of participants planned to continue using CGM all or most of the time. There was a very high self-reported effect of CGM on life with diabetes (median 8.0 [interquartile range 6.5-10.0], where 10 indicated a very big difference). Hypoglycemia confidence and fear improve with CGM use in young adults.

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.

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. To validate the Italian version of the CHFS and PHFS. 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). 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.

Effectiveness of Mindfulness-Based Stress Reduction Training on Emotional Expressiveness and Fear of Hypoglycemia in Patients with Type 2 Diabetes

Objective: Diabetes is a common chronic disorder in which there is a high risk of physical complications and psychological problems such as hypoglycemia and inability to express emotions. Psychological interventions can be effective in this regard. The aim of this study was to investigate the effectiveness of mindfulness-based stress reduction (MBSR) training on emotional expressiveness and fear of hypoglycemia (FOH) in patients with type 2 diabetes visiting Yazd Diabetes Center. Materials and Methods: This study was a quasi-experimental study with a pretest and posttest design. The statistical population was all patients with type 2 diabetes visiting Yazd Diabetes Center in 2020. Forty men and women were selected using purposeful sampling and were randomly allocated to case and control groups. The case group received 8 sessions of MBSR training, 2 hours each and the control group received no interventions. Emotional Expressiveness Questionnaire (EEQ) and the Hypoglycemia Fear Survey (HFS) were used to collect data. Results: Results of ANCOVA showed that MBSR training significantly increases emotional expressiveness and its components (P-value&lt; 0.0001) and decreases the fear of hypoglycemia (P-value&lt; 0.0001) in patients with type 2 diabetes (P-value&lt; 0.035). Conclusion: Based on the results of the study, MBSR training could improve emotional expressiveness, prevent hypoglycemia and reduce the fear of it.

Diabetes Device Downloading: Benefits and Barriers Among Youth With Type 1 Diabetes.

The majority of youth with type 1 diabetes (T1D) fail to meet glycemic targets despite increasing continuous glucose monitoring (CGM) use. We therefore aimed to determine the proportion of caregivers who review recent glycemic trends ("retrospective review") and make ensuant insulin adjustments based on this data ("retroactive insulin adjustments"). We additionally considered that fear of hypoglycemia and frequency of severe hypoglycemia would be associated with performing retrospective review. We conducted a cross-sectional survey of caregivers of youth with T1D, collecting demographics, diabetes technology usage, patterns of glucose data review/insulin dose self-adjustment, and Hypoglycemia Fear Survey (HFS). Nineteen percent of eligible caregivers (191/1003) responded. Performing retrospective review was associated with younger child age (12.2 versus 15.4, P = .0001) and CGM use (92% versus 73%, P = .004), but was not associated with a significant improvement in child's HbA1c (7.89 versus 8.04, P = .65). Retrospective reviewers had significantly higher HFS-behavior scores (31.9 versus 27.7, P = .0002), which remained significantly higher when adjusted for child's age and CGM use (P = .005). Linear regression identified a significant negative association between HbA1c (%) and number of retroactive insulin adjustments (0.24 percent lower mean HbA1c per additional adjustment made, P = .02). Retrospective glucose data review is associated with improved HbA1c when coupled with data-driven retroactive insulin adjustments. Barriers to data downloading existed even in this cohort of predominantly CGM-using T1D families.