Fear Of Hypoglycemia Research Articles

1502-PUB: Intensive vs. Conventional Insulin Therapy Treatment for Paediatric Diabetes

Background: Intensive insulin therapy is progressively replacing conventional therapy in young children to improve diabetes control. However, the specific skills required to manage insulin pumps may hamper social integration as the fear of severe hypoglycemia using conventional therapy. Methods: Influences of a continuous education program targeting parents and their substitutes in their living places, was evaluated in 23 subjects aged 2.3 ± 0.2 years treated by insulin pump (CSII) for 3.2 ± 0.6 years and compared to 23 subjects aged 3.2 ± 0.2 years treated by conventional therapy (CV) for 3.5 ± 0.3 y. Results: HbA1c levels were undistinguishable in both groups throughout the study period, remaining within recommended ADA target. Whereas a greater escalation of insulin dose was witnessed amongst the CV group (0.57 ± 0.to 0.79 ± 0.03 U/kg/day) versus 0.64 ± 0.to 0.70 ± 0.U/kg/day (ns) in the CSII group over time, inter-group differences failed to reach significance. BMI SDS increased significantly in the CSII group. No significant difference had been seen in the number of days of admission/ subject and the number of admissions for severe hypoglycemia. The number of admissions for ketoacidosis was high in the CSII group (p = 0.027) . Conclusions: Externalizing targeted education programs on the child's living place allows minimizing hypoglycaemia risks of CV. This result may be particularly relevant for under-developed countries and contribute to the reduction of the costs of diabetes management without increasing side effects. Disclosure A.Das: None.

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<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<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 & 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 & 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)

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 > 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 > 60 (p < 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<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<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<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

Impact of continuous glucose monitoring in youth with type 1 diabetes aged 15-21 years.

People with type 1 diabetes (T1D) aged <21 years are eligible for subsidised continuous glucose monitoring (CGM) products under the Australian National Diabetes Services Scheme. There are few real-world published studies to evaluate the benefits of CGM in young adults. To perform a real-world observation study among youth with T1D to evaluate CGM use and benefits of CGM. Patients at the Westmead Hospital Young Adult Diabetes Clinic aged 15-21 years who commenced CGM before July 2018 were followed for 6 months post commencement of CGM. Differences in HbA1c and glucose metrics at baseline and follow up are compared between those commencing CGM and those that did not. Forty-four (38%) of 115 eligible patients commenced CGM. Demographic characteristics and baseline HbA1c did not differ significantly between those started on CGM and those that did not. At 6 months, 18 (41%) of 44 patients still used CGM, with discomfort and inconvenience the most common reasons for dropout. In CGM continuers, at 6 months compared with baseline, there was no change in HbA1c (8.2% vs 8.0%; P = 0.8), coefficient of variation of glucose (38% vs 39%; P = 0.5) or percentage time in range (52% vs 58%; P = 0.3). Six-month follow-up HbA1c in CGM non-users deteriorated significantly compared with users. Mean hypoglycaemia fear scores (worry scale) were significantly decreased from baseline at 6 months (33 vs 18; P < 0.01). There are high rates of discontinuation in CGM use among youth with T1D. At 6 months of CGM use, there was no significant change in glycaemic control, although HbA1c in non-users deteriorated significantly. Worry of hypoglycaemia was significantly decreased among those who continued CGM.

Fear of hypoglycemia-An underestimated problem.

IntroductionFear of hypoglycemia (FOH) is a phenomenon that affects people with diabetes experiencing hypoglycemia. On the one hand, FOH is an adaptive mechanism that helps to protect patients from hypoglycemia and its consequences. On the other hand, the non‐normative level of FOH causes anxiety and tension, disturbs normal functioning, and makes normoglycemia maintenance difficult.ObjectiveThe main objective of this review was to describe factors influencing FOH and methods of measurement of FOH levels. Moreover, we highlighted the impact of the new technologies used in diabetes therapy on FOH and different therapeutic possibilities helping patients cope with excessive levels of FOH. We also presented clinical cases of patients with high FOH levels met in clinical practice and discussed methods to better diagnose and assist people with this kind of problem.MethodsWe searched for studies and articles via PubMed using the keywords fear of hypoglycemia, diabetes, and hypoglycemia. From screened documents identified from literature search, 67 articles were included in our review.ResultsWe divided results from literature screening into five parts: fear of hypoglycemia and hypoglycemia definition, risk factors for the FOH, methods of measuring levels of FOH, therapies for the FOH, and modern technologies. We also described clinical examples of abnormal fear of hypoglycemia in patients.ConclusionThe review highlights the importance of taking into consideration fear of hypoglycemia phenomenon in diabetic patients in everyday clinical practice.

Bring Blood Glucose Down! An intervention to reduce fear of hypoglycemia in caregivers of adolescents with type 1 diabetes: Study design and participant characteristics

Fear of hypoglycemia (FOH) is anxiety or extreme worry about having a low blood glucose and its consequences. FOH is common in individuals with type 1 diabetes (T1D) of all ages, as well as their caregivers, and can lead to inappropriate T1D self-management and suboptimal health outcomes. Despite its prevalence and serious health consequences, there has been very little attention focused on developing interventions to reduce FOH and its associated maladaptive T1D management behaviors. The primary aim of the present study, Bring BG Down!, was to implement a pilot intervention targeting FOH in mothers of adolescents with T1D. Exploratory aims included determining if the intervention had an impact on the adolescent's FOH, glycemia, as well as other generalized anxiety symptoms or symptoms of obsessive-compulsive disorder in both the mother and adolescent. Caregiver participants and their adolescents with T1D were randomized to either the Bring BG Down! group or the Control group. Individuals in the Bring BG Down! group participated in intervention sessions for 6 months via telehealth and they completed questionnaires, whereas those in the Control group only completed questionnaires. Follow-up occurred at 7-months and 10-months. The purpose of this paper is to describe the Bring BG Down! study design and rationale, and participant characteristics at the start of the study.

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.

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

To examine the impact of real-time continuous glucose monitoring (rtCGM) on psychosocial outcomes in adults with insulin-using type 2 diabetes (T2D). 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. 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). 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.

Common Sense Model program on illness perceptions in patients with impaired awareness of hypoglycemia

Background: Illness perceptions are important for patients with insulin-treated type 2 diabetes mellitus (T2DM) and impaired awareness of hypoglycemia (IAH), as they determine health-related behaviors and motivations. Patients with IAH in many countries have poor illness perception, and there is a paucity of research exploring the effectiveness of Common Sense Model (CSM)-based interventions in this population. Objective: To investigate the effects of a CSM-based intervention program on perceptions of illness in patients with insulin-treated T2DM and IAH. Design: Quasi-randomized controlled trial. Methods: 78 patients with IAH receiving routine care were included. The intervention group (n = 39) participated in a CSM-based program, whereas the control group (n = 39) did not. Illness perceptions, coping styles, hypoglycemia fear, and awareness of hypoglycemia at baseline, 1, and 3 months were analyzed and compared between the two groups. Results: The intervention group exhibited significant improvements in consequences (β = -1.615, P = 0.032); personal control (β = −1.897, P = 0.006); treatment control (β = −1.274, P = 0.046); and positive coping style (β = 4.872, P = 0.002) at the 3-month follow-up, and timeline (β = 2.769, P = 0.004) at the 1-month follow-up. Hypoglycemia fear and awareness were not significantly improved in the intervention group compared with the control group. No intervention-related adverse events were observed. Conclusions: A CSM-based intervention program can modify illness perceptions to an extent and improve the positive coping style in patients with IAH. Impact statementNurses should conduct a CSM-based intervention program to help patients with IAH improve illness perceptions.

Efficacy of GLP-1 RA Approved for Weight Management in Patients With or Without Diabetes: A Narrative Review.

The approval of once daily liraglutide, 3.0 mg, and once weekly semaglutide, 2.4 mg, for chronic weight management provides a novel effective strategy against obesity. The reliable models that might predict weight reducing potential at the individual level have not been identified yet. However, the coexistence of diabetes has been consistently related with less effective response than in people without this comorbidity. We aimed to review the efficacy of GLP-1 RAs approved for weight management in individuals with and without diabetes and discuss some potential mechanisms for consistently observed differences in efficacy between these two populations. The mean weight loss difference between GLP-1 RAs and placebo as add-on to lifestyle intervention in patients with diabetes was 4% to 6.2% compared to 6.1 to 17.4% in people without diabetes. Semaglutide compared to liraglutide resulted in greater weight loss. Some hypothetical explanations for the weaker anti-obesity response for both GLP-1 RAs in people with diabetes include the background medications that promote weight gain, the fear of hypoglycaemia inherently related to the treatment of diabetes, a decrease in glycosuria and subsequently less weight loss in diabetics, an altered microbiota in patients with obesity and diabetes and a genetic background that predispose to weight gain in patients with diabetes. Moreover, people with diabetes may have had obesity for longer and may be less adherent to exercise, which seems to potentiate the effects of GLP-1 RA. Emerging multimodal approaches combining peptides targeting receptors at different levels might therefore be of additional benefit particularly in patients with diabetes.

A parallel randomised controlled trial of the Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised self-care (HARPdoc)

Impaired awareness of hypoglycaemia (IAH) is a major risk for severe hypoglycaemia in insulin treatment of type 1 diabetes (T1D). To explore the hypothesis that unhelpful health beliefs create barriers to regaining awareness, we conducted a multi-centre, randomised, parallel, two-arm trial (ClinicalTrials.gov NCT02940873) in adults with T1D and treatment-resistant IAH and severe hypoglycaemia, with blinded analysis of 12-month recall of severe hypoglycaemia at 12 and/or 24 months the primary outcome. Secondary outcomes included cognitive and emotional measures. Adults with T1D, IAH and severe hypoglycaemia despite structured education in insulin adjustment, +/− diabetes technologies, were randomised to the “Hypoglycaemia Awareness Restoration Programme despite optimised self-care” (HARPdoc, n = 49), a psychoeducation programme uniquely focussing on changing cognitive barriers to avoiding hypoglycaemia, or the evidence-based “Blood Glucose Awareness Training” (BGAT, n = 50), both delivered over six weeks. Median [IQR] severe hypoglycaemia at baseline was 5[2–12] per patient/year, 1[0–5] at 12 months and 0[0–2] at 24 months, with no superiority for HARPdoc (HARPdoc vs BGAT incident rate ratios [95% CI] 1.25[0.51, 3.09], p = 0.62 and 1.26[0.48, 3.35], p = 0.64 respectively), nor for changes in hypoglycaemia awareness scores or fear. Compared to BGAT, HARPdoc significantly reduced endorsement of unhelpful cognitions (Estimated Mean Difference for Attitudes to Awareness scores at 24 months, −2.07 [−3.37,−0.560], p = 0.01) and reduced scores for diabetes distress (−6.70[−12.50,−0.89], p = 0.02); depression (−1.86[−3.30, −0.43], p = 0.01) and anxiety (−1.89[−3.32, −0.47], p = 0.01). Despite positive impact on cognitive barriers around hypoglycaemia avoidance and on diabetes-related and general emotional distress scores, HARPdoc was not more effective than BGAT at reducing severe hypoglycaemia.

Congenital Hyperinsulinism International: A Community Focused on Improving the Lives of People Living With Congenital Hyperinsulinism.

Congenital hyperinsulinism (HI) is a rare disease affecting newborns. HI causes severe hypoglycemia due to the overproduction of insulin. The signs and symptoms of hypoglycemia in HI babies is often not discovered until brain damage has already occurred. Prolonged hypoglycemia from HI can even lead to death. Disease management is often complex with a high burden on caregivers. Treatment options are extremely limited and often require long hospital stays to devise. Cascading from suboptimal treatments and diagnostic practices are a host of other problems and challenges that many with HI and their families experience including continued fear of hypoglycemia and feeding problems. The aim of this paper is (1) to describe the current challenges of living with HI including diagnosis and disease management told from the perspective of people who live with the condition (2), to provide family stories of life with HI, and (3) to share how a rare disease patient organization, Congenital Hyperinsulinism International (CHI) is working to improve the lives of HI patients and their families. CHI is a United States based nonprofit organization with a global focus. The paper communicates the programs the patient advocacy organization has put into place to support HI families through its virtual and in-person gatherings. The organization also helps individuals access diagnostics, medical experts, and treatments. CHI also raises awareness of HI to improve patient outcomes with information about HI and prolonged hypoglycemia in twenty-three languages. CHI drives innovation for new and better treatments by funding research pilot grants, conducting research through the HI Global Registry, and providing patient experience expertise to researchers developing new treatments. The organization is also the sponsor of the CHI Collaborative Research Network which brings medical and scientific experts together for the development of a patient-focused prioritized research agenda.

Strengths and Challenges of Closed-Loop Insulin Delivery During Exercise in People With Type 1 Diabetes: Potential Future Directions.

Exercise has many physical and psychological benefits and is recommended for people with type 1 diabetes; however, there are many barriers to exercise, including glycemic instability and fear of hypoglycemia. Closed-loop (CL) systems have shown benefit in the overall glycemic management of type 1 diabetes, including improving HbA1c levels and reducing the incidence of nocturnal hypoglycemia; however, these systems are challenged by the rapidly changing insulin needs with exercise. This commentary focuses on the principles, strengths, and challenges of CL in the management of exercise, and discusses potential approaches, including the use of additional physiological signals, to address their shortcomings in the pursuit of fully automated CL systems.

In-home use of a hybrid closed loop achieves time-in-range targets in preschoolers and school children: Results from a randomized, controlled, crossover trial.

To obtain additional information on the incremental differences between using a sensor-augmented pump (SAP) without automated insulin delivery (AID), using it with predictive low-glucose management (PLGM) or as hybrid closed loop (HCL), in preschool and school children. We conducted a monocentric, randomized, controlled, two-phase crossover study in 38 children aged 2-6 and 7-14 years. The primary endpoint was the percentage of time in range (TIR) of 70-180 mg/dl. Other continuous glucose sensor metrics, HbA1c, patient-related outcomes (DISABKIDS questionnaire, Fear of Hypoglycaemia Survey) and safety events were also assessed. Results from 2 weeks of SAP, 8 weeks of PLGM and 8 weeks of HCL were compared using a paired t-test or Wilcoxon signed-rank test. Overall, we found a high rate of TIR target (>70%) achievement with HCL in preschool (88%) and school children (50%), with average times in Auto Mode of 93% and 87%, respectively. Preschool children achieved a mean TIR of 73% ± 6% (+8% vs. SAP, +6% vs. PLGM) and school children 69% ± 8% (+15% vs. SAP and + 14% vs. PLGM). Overall, HbA1c improved from 7.4% ± 0.9% to 6.9% ± 0.5% (P= .0002). Diabetes burden and worries and fear of hypoglycaemia remained at low levels, without significant changes versus PLGM. No events of severe hypoglycaemia or diabetic ketoacidosis occurred. Preschool children profit from AID at least as much as those aged 7 years and older. To ensure safe use and prescribing modalities, regulatory approval is also required for young children.

Young Children with Type 1 Diabetes: Recent Advances in Behavioral Research.

Purpose of ReviewThis review provides a recent update of behavioral research pertinent to young children with T1D and addresses current priorities and future directions.Recent FindingsRates of type 1 diabetes (T1D) in young children (ages 1–7) are continuing to rise. Since 2014, changes to diabetes care and management have impacted young children and reinforced the need for increased attention and interventions to support diabetes management, especially in caregivers who are primarily responsible for their young child’s diabetes management.SummaryT1D is associated with unique physiologic challenges in young children, with constant management demands elevating parental diabetes-related stress and fear of hypoglycemia. Diabetes technology use has significantly increased in young children, contributing to improvements in glycemic levels and parent and child psychosocial functioning. Yet despite the positive outcomes demonstrated in select clinical behavioral interventions, research with this young child age group remains limited in scope and quantity.

Effectiveness of adding alarms to flash glucose monitoring in adults with type 1 diabetes under routine care

AimWhether glucose sensor alarms improve metabolic control and are accepted by individuals with diabetes is unclear. Here, we investigated whether switching from a standard flash glucose monitoring system (FGM1) to a system equipped with hypo- and hyperglycemia alarms (FGM2) improves glycemic control and psychological outcomes in adults with type 1 diabetes (T1D).MethodsSubjects with T1D and > 4% of time in hypoglycemia or > 40% of time in hyperglycemia were studied while wearing FGM1 (4 weeks) and after switching to FGM2 for 8 weeks. The primary endpoint was the change in time in range (TIR 70–180 mg/dl [3.9–10.0 mmol/L]) after 4 weeks of FGM2 use. Time below range (TBR), time above range (TAR), mean glucose, coefficient of variation (CV), sensor scans, treatment satisfaction, and hypoglycemia fear were secondary outcomes.ResultsWe included 38 subjects aged 33.7 ± 12.6 year. During 4 weeks of FGM2 use, TIR increased from 52.8 to 57.0% (p = 0.001), TBR decreased from 6.2 to 3.4% (p < 0.0001) as did time < 54 mg/dl (from 1.4 to 0.3%, p < 0.0001) and CV (from 39.6% to 36.1%, p < 0.0001). These changes were confirmed after 8 weeks of FGM2 use. Treatment satisfaction improved and fear of hypoglycemia decreased.Subjects who had > 4% of time in hypoglycemia at baseline showed the greatest improvements in glucose control and treatment satisfaction.ConclusionSwitching from FGM1 to FGM2 improved TIR and treatment satisfaction and reduced fear of hypoglycemia. Participants who benefited most from switching from FGM1 to FGM2 were those prone to hypoglycemia.

IDF21-0545 Assessment of the Relationship between Hypoglycemia and Frailty in Elderly People with Diabetes

Background: Diabetes may cause a decrease in both physiological and cognitive reserves when featured with the state of frailty in elderly individuals. Hypoglycemia is both an indicator and trigger of frailty. Hypoglycemia management in frail elderly requires different strategies than standard approaches, however, the literature is quite limited on this subject. Aim: This descriptive, exploratary study examined the relationship between frailty and hypoglycemia in individuals aged 65 years and above. Method: The study comprised 196 patients with diabetes. Data were collected through the patient information form, the Hypoglycemia Fear Scale (HFS), and the Edmonton Frailty Scale (EFS). Data were analyzed in SPSS 26 by using percentages, means, standard deviations, t-test, one-way analysis of variance (with Tukey HSD post hoc test), Pearson correlation analysis, and regression analysis. The significance level was accepted as p<0.05. Results: It was found that 69.9% of the subjects were female, that 82.1% were at the 65–74 age range, that blood sugar levels of 76.5% dropped below 70 mg/dl at least once after diagnosis (hypoglycemia), and that 17.8% were severely frail. The EFS mean result was higher in individuals who had hypoglycemia (7.86 ± 3.02) than those who did not have hypoglycemia (6.26 ± 3.12); hypoglycemia insensitivity (8.22 ± 3.31) was found to be significantly higher than those who did not have hypoglycemia (6.26 ± 3.12) (p=0.02 and p = 0.007). A positive correlation was found between both HFS total score and HFS behavior and anxiety sub-dimensions and EFS score (r =.32, p <.001; r =.27, p = .001; r = .30, respectively). p < .001) Linear regression analysis showed that hypoglycemia fear level of individuals explained frailty score by 10%. (R2 Linear: 0.104, p < 0.001). As a result, when the hypoglycemia fear scores of individuals with diabetes increase, the frailty scores increase. Fear of hypoglycemia explains 10% of the frailty. Discussion: These results indicate the importance of preventing hypoglycemia in the prevention of fragility in elderly people with diabetes, thereby highlighting the importance of approaches to reduce the risk of hypoglycemia in elderly people with diabetes.

IDF21-0544 Artificial Intelligence in Diabetes Care

Background: Artificial intelligence (AI) is making a paradigm shift in traditional diabetes care in terms of target achieving efficacy, excellent safety, best quality care, effective monitoring and improved quality of life for both patients with Type-1 diabetes (T1D) and Type-2 diabetes (T2D). All guidelines for adult and pediatric T1D suggest that target Glycated hemoglobin (HbA1c) should be less than 53 mmol/mol (7%) but very less percent population with T1D can achieve this target due to many factors namely individual variability of insulin requirements, fear of hypoglycemia, errors in insulin dose calculations, etc. These lead to poor glycemic control, diabetes complications and a major source of stress for families and care givers especially in pediatric populations. All these affects quality of life (QoL), mental well-being and productivity of patients. So, the emergence of AI in diabetes care has revolutionized the management of diabetes care in optimizing the glycemic control by extending the ‘Target In Range’ (TIR), reducing ‘Target Above Range’ (TAR), ‘Target Below Range’ (TBR) and minimizing severe hypoglycemia. Glucose monitoring by Self Monitoring Blood Glucose (SMBG) using smart glucometer or Ambulatory glucose profile (AGP), Continuous Glucose Monitoring System (CGMS), to name a few. AI is being used in delivering insulin by smart pens, Continuous Subcutaneous Insulin Infusion (CSII), recently introduced Hybrid Artificial Pancreas and with prolonged CGMS. Smart insulin pens namely InPen, Novo Pen 6, Novo Pen Echo Plus, etc. can calculate the bolus dose considering current glucose reading, target, carb intake, probable exercise, etc. by algorithm. Furthermore, it can record the amount and timing of each insulin dose, display the last dose and insulin onboard, and wirelessly transmit the information via Bluetooth to a dedicated mobile application and transfers data automatically on the cloud for sharing with health care professionals as well. Novo Pen 6 and Novo Pen Echo Plus use near-field communication technology. CGMS uses sensor to monitor blood glucose continuously for 14 days and shows results in real-time without using a needle which made the life of young children much comfortable. It calculates TIR, TAR, TBR and probable HbA1c in a graphic presentation. Now new models are in pipeline for much longer duration. Smart glucometers are incorporated with bolus advisors to calculate insulin dosages, algorithm-driven message response to each glucose reading. The Hybrid Close Loop artificial pancreas is the new generation of CSII which automatically determines the basal rates, can determine the bolus dose as per CGMS but this feature is still under trial and having other old generation basic and advanced features. The ongoing trials results will guide further improvements and eventually will lead complete AI based diabetes management. Aim: To see the scope, feasibility and critical role of AI in diabetes care. Method: Contemporary literature is being searched to get the latest information on AI use in diabetes care. Results: PubMed, MEDLINE, CINAHL Plus, EMBASE, Cochrane and Google Scholar is being searched with search words 'Artificial Intelligence AND Diabetes', 'Artificial Pancreas', Close Loop system', 'Smart Insulin Pen'. 312 articles were found and finally 34 were selected.

Clinical Use of Insulin Glargine 300U/mL in Adults with Type2 Diabetes: Hypothetical Case Studies.

Type 2 diabetes (T2D) is a progressive disease, with many individuals eventually requiring basal insulin therapy to maintain glycaemic control. However, there exists considerable therapeutic inertia to the prompt initiation and optimal titration of basal insulin therapy due to barriers that include fear of injections, hypoglycaemia, weight gain, and burdensome regimens. Hypoglycaemia is thought to be a major barrier to optimal glycaemic control and is associated with significant morbidity and mortality. Newer second-generation basal insulin analogues provide comparable glycaemic control with lower risk of hypoglycaemia compared with first-generation basal insulin analogues. The present review article discusses clinical evidence for one such second-generation basal insulin analogue, insulin glargine 300 U/mL (Gla-300), in the context of hypothetical case studies that are representative of individuals who may attend routine clinical practice. These case studies discuss individualised treatment needs for people with T2D who are insulin-naïve or pre-treated. Clinical characteristics such as older age, frequent nocturnal hypoglycaemia, and renal impairment, which are known risk factors for hypoglycaemia, are also considered.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01247-7.

Long-term cost-effectiveness of Dexcom G6 real-time continuous glucose monitoring system in people with type 1 diabetes in Australia.

IntroductionReal‐time continuous glucose monitoring (rt‐CGM) allows patients with diabetes to adjust insulin dosing, potentially improving glucose control. This study aimed to compare the long‐term cost‐effectiveness of the Dexcom G6 rt‐CGM device versus self‐monitoring of blood glucose (SMBG) and flash glucose monitoring (FGM) in Australia in people with type 1 diabetes (T1D).MethodsLong‐term costs and clinical outcomes were estimated using the CORE Diabetes Model. Clinical input data for the analysis of rt‐CGM versus SMBG and FGM were sourced from the DIAMOND study and a network meta‐analysis, respectively. Rt‐CGM and FGM were associated with quality of life (QoL) benefits due to reduced fear of hypoglycaemia (FoH) and fingerstick testing. Analyses were performed over a lifetime time horizon from an Australian healthcare payer perspective, including direct costs from published data. Future costs and clinical outcomes were discounted at 5% per annum.ResultsRt‐CGM was associated with an increased quality‐adjusted life expectancy of 1.199 quality‐adjusted life years (QALYs), increased mean total lifetime costs of AUD 21,596 and an incremental cost‐effectiveness ratio (ICER) of AUD 18,020 per QALY gained compared with SMBG.Compared with FGM, rt‐CGM was associated with an increased quality‐adjusted life expectancy of 0.569 QALYs, increased mean total lifetime costs of AUD 11,064 and an ICER of AUD 19,455 per QALY gained. Key drivers of outcomes included HbA1c benefits and QoL benefits associated with reduced FoH and fingerstick testing.ConclusionsDue to improved clinical outcomes and QoL gains rt‐CGM is highly cost‐effective compared with SMBG and FGM in people with T1D in Australia.