The diabetes body project: Study protocol of a multi-site trial of a virtually delivered eating disorder prevention program for young women with type 1 diabetes.

AIM: Young women with type 1 diabetes are a high-risk population for eating disorders (ED). Prevention programs are lacking. In young women without diabetes, the Body Project has produced reductions in ED risk factors, ED symptoms and future ED onset. Therefore, the Body Project was adapted to type 1 diabetes, the Diabetes Body Project (DBP). In this protocol, we describe the multi-site randomized controlled trial (RCT) to evaluate efficacy of the DBP. METHODS: This is an ongoing RCT with four sites (Europe and US). In total 280, 14-35 year-old, women with type 1 diabetes ≥1 year and some level of body image concerns will be recruited in 2023. Participants are randomized to either virtual DBP groups or an educational control. The study constitutes 5 measurement points distributed over 2 years. The primary aim is to test if DBP will produce significantly greater reductions in ED behaviours, ED symptoms and future ED onset. The secondary aim is to test if DBP has significantly greater improvements in diabetes distress, quality of life and glycaemic outcomes. RESULTS: We expect that DBP will be more efficacious in reducing ED behaviours, ED symptoms and ED onset compared to the control condition. Additionally, we hope to gain new knowledge on how DBP may affect diabetes-related outcomes. CONCLUSIONS: If DBP proves efficacious, it has potential for immediate, clinical implementation at low-cost and may contribute to broad prevention of future ED onset among young women with type 1 diabetes. GOV IDENTIFIER: NCT05399446.

Glucose Targets Using Continuous Glucose Monitoring Metrics in Older Adults With Diabetes: Are We There Yet?

The older population is increasing worldwide and up to 30% of older adults have diabetes. Older adults with diabetes are at risk of glucose-related acute and chronic complications. Recently, mostly in type 1 diabetes (T1D), continuous glucose monitoring (CGM) devices have proven beneficial in improving time in range (TIR glucose, 70-180 mg/dL or glucose 3.9-10 mmol/L), glycated hemoglobin (HbA1c), and in lowering hypoglycemia (time below range [TBR] glucose <70 mg/dL or glucose <3.9 mmol/L). The international consensus group formulated CGM glycemic targets relating to older adults with diabetes based on very limited data. Their recommendations, based on expert opinion, were aimed at mitigating hypoglycemia in all older adults. However, older adults with diabetes are a heterogeneous group, ranging from healthy to very complex frail individuals based on chronological, biological, and functional aging. Recent clinical trial and real-world data, mostly from healthy older adults with T1D, demonstrated that older adults often achieve CGM targets, including TIR recommended for non-vulnerable groups, but less often meet the recommended TBR <1%. Existing data also support that hypoglycemia avoidance may be more strongly related to minimization of glucose variability (coefficient of variation [CV]) rather than lower TIR. Very limited data are available for glucose goals in older adults adjusted for the complexity of their health status. Herein, we review the bidirectional associations between glucose and health status in older adults with diabetes; use of diabetes technologies, and their impact on glucose control; discuss current guidelines; and propose a new set of CGM targets for older adults with insulin-treated diabetes that are individualized for health and living status.

Evaluation of hybrid closed-loop insulin delivery system in type 1 diabetes in real-world clinical practice: One-year observational study.

BACKGROUND: In 2016, the Food and Drug Administration approved the first hybrid closed-loop (HCL) insulin delivery system for adults with type 1 diabetes (T1D). There is limited information on the impact of using HCL systems on patient-reported outcomes (PROs) in patients with T1D in real-world clinical practice. In this independent study, we evaluated glycemic parameters and PROs over one year of continuous use of Medtronic's 670G HCL in real-world clinical practice. AIM: To assess the effects of hybrid closed loop system on glycemic control and quality of life in adults with T1D. METHODS: We evaluated 71 patients with T1D (mean age: 45.5 ± 12.1 years; 59% females; body weight: 83.8 ± 18.7 kg, body mass index: 28.7 ± 5.6 kg/m2, A1C: 7.6% ± 0.8%) who were treated with HCL at Joslin Clinic from 2017 to 2019. We measured A1C and percent of glucose time-in-range (%TIR) at baseline and 12 months. We measured percent time in auto mode (%TiAM) for the last two weeks preceding the final visit and assessed PROs through several validated quality-of-life surveys related to general health and diabetes management. RESULTS: At 12 mo, A1C decreased by 0.3% ± 0.1% (P = 0.001) and %TIR increased by 8.1% ± 2.5% (P = 0.002). The average %TiAM was only 64.3% ± 32.8% and was not associated with A1C, %TIR or PROs. PROs, provided at baseline and at the end of the study, showed that the physical functioning submodule of 36Item Short-Form Health Survey increased significantly by 22.9% (P < 0.001). Hypoglycemia fear survey/worry scale decreased significantly by 24.9% (P < 0.000); Problem Areas In Diabetes reduced significantly by -17.2% (P = 0.002). The emotional burden submodules of dietary diversity score reduced significantly by -44.7% (P = 0.001). Furthermore, analysis of Clarke questionnaire showed no increase in awareness of hypoglycemic episodes. WHO-5 showed no improvements in subject's wellbeing among participants after starting the 670G HCL system. Finally, analysis of Pittsburgh Sleep Quality Index showed no difference in sleep quality, sleep latency, or duration of sleep from baseline to 12 mo. CONCLUSION: The use of HCL in real-world clinical practice for one year was associated with significant improvements in A1C, %TIR, physical functioning, hypoglycemia fear, emotional distress, and emotional burden related to diabetes management. However, these changes were not associated with time in auto mode.

Mitigating Severe Hypoglycemia in Users of Advanced Diabetes Technologies: Impaired Awareness of Hypoglycemia and Unhelpful Hypoglycemia Beliefs as Targets for Interventions.

Objective: A subgroup analysis of the Hypoglycemia Awareness Restoration Programme for people with type 1 diabetes and problematic hypoglycemia persisting despite optimized care (HARPdoc) trial was conducted to explore the impact of Blood Glucose Awareness Training (BGAT, a hypoglycemia awareness training program) and the HARPdoc (a psychoeducation addressing unhelpful hypoglycemia beliefs) in reducing severe hypoglycemia (SH) in individuals using advanced diabetes technologies (ADTs). Methods: Data from trial participants who utilized ADTs, including continuous glucose monitors or automated insulin delivery systems, were extracted. Generalized linear mixed-effects models with Poisson distribution or linear mixed-effects models were used to evaluate SH incidence, and Gold questionnaire, Attitudes to Awareness of Hypoglycemia (A2A), Problem Areas in Diabetes (PAID), Hospital Anxiety and Depress Scale (HADS)-anxiety, and HADS-depression scores as measures of hypoglycemia awareness, unhelpful hypoglycemia beliefs, diabetes distress, and anxiety and depression symptoms, respectively. Results: In the 45 participants using ADTs, the BGAT and HARPdoc interventions both reduced SH incidence by more than 50% (P < 0.0001) and yielded improvements in hypoglycemia awareness (P < 0.05). HARPdoc outperformed BGAT in reducing SH at month 24 (P = 0.01). HARPdoc also mitigated unhelpful hypoglycemia beliefs (P < 0.0001), diabetes distress (P < 0.05), and anxiety symptoms (P < 0.05); BGAT demonstrated no significant impacts in these respects. Neither HARPdoc nor BGAT had significant effects on depression symptoms. Conclusion: Psychoeducation (BGAT and HARPdoc) was effective in reducing SH in people using ADTs. HARPdoc may also provide greater long-term SH reduction and improves psychological well-being in this patient group.

Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT.

AIMS: To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial. METHODS: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT. RESULTS: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0. CONCLUSIONS: Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.

Overcoming Barriers to Diabetes Management in Young Adults with Type 1 Diabetes by Leveraging Telehealth: A Pilot Study.

OBJECTIVE: The LIFT-YA (leveraging intensive follow-up treatment in young adults) quality improvement program was developed to address clinical and social barriers in young adults (YA) with type 1 diabetes (T1D), using telehealth visits to promote clinic attendance and improve diabetes care. METHODS: LIFT-YA enrolled YA aged 18-30 with T1D and HbA1c >8% (64 mmol/mol) who had established adult care in our diabetes clinic. The 6-month, 7-visit hybrid program was facilitated by a case manager serving as the liaison between participants and the care team. The primary end-points were within-group and between-group changes from the baseline in HbA1c at the last visit and adoption of continuous glucose monitoring (CGM). RESULTS: Of the 57 eligible YA, 24 were enrolled and 33 were unable to participate (UTP). Thirteen of the enrolled participants attended at least 4/7 visits ("completers", C), whereas 11 were noncompleters (NC). HbA1c at the end of the program was significantly lower in the C versus UTP group [median -1.0; IQR (-0.6, -2.5) vs -0.25 (0.2, -1.0) in UTP; P < .05]. The percentage of CGM users significantly increased by 70% in the C group (P < .05), but did not change in the NC and UTP groups. Limited access to telehealth and the high cost of frequent visits were the main hurdles preventing enrollment into or completion of the program. CONCLUSIONS: The LIFT-YA pathway was associated with a significant HbA1c reduction and an increase in the adoption of CGM. Policy changes are necessary to expand access to LIFT-YA and other programs for high-risk YA with T1D in underserved communities and across all backgrounds.

The Growing Role of Technology in the Care of Older Adults With Diabetes.

The integration of technologies such as continuous glucose monitors, insulin pumps, and smart pens into diabetes management has the potential to support the transformation of health care services that provide a higher quality of diabetes care, lower costs and administrative burdens, and greater empowerment for people with diabetes and their caregivers. Among people with diabetes, older adults are a distinct subpopulation in terms of their clinical heterogeneity, care priorities, and technology integration. The scientific evidence and clinical experience with these technologies among older adults are growing but are still modest. In this review, we describe the current knowledge regarding the impact of technology in older adults with diabetes, identify major barriers to the use of existing and emerging technologies, describe areas of care that could be optimized by technology, and identify areas for future research to fulfill the potential promise of evidence-based technology integrated into care for this important population.

Self-care barriers and facilitators in older adults with T1D during a time of sudden isolation.

Older adults with type 1 diabetes (T1D) have unique challenges and needs. In this mixed-methods study, we explored the impact of isolation during a pandemic on diabetes management and overall quality of life in this population. Older adults (age ≥ 65 years) with T1D receiving care at a tertiary care diabetes center participated in semi-structured interviews during COVID-19 pandemic isolation between June and August 2020. A multi-disciplinary team coded transcripts and conducted thematic analysis. Thirty-four older adults (age 71 ± 5 years, 97% non-Hispanic white, diabetes duration of 38 ± 7 years, A1C of 7.4 ± 0.9% (57.3 ± 10.1 mmol/mol) were recruited. Three themes related to diabetes self-care emerged regarding impact of isolation on: (1) diabetes management and self-care behaviors (how isolation prompted changes in physical activity and dietary habits); (2) emotional stress and anxiety (related to isolation and lack of support system, economic concerns); and (3) concerns regarding the COVID-19 pandemic (impact on timely medical care and access to information). Our findings identify modifiable barriers and challenges faced by older adults with T1D during isolation. As this population has a higher risk of decline in physical and psychosocial support even during non-pandemic times, clinicians will benefit from understanding these issues to improve care of this population.

Type 1 Diabetes and Aging.

The number of older adults with type 1 diabetes (T1D) is increasing due to an overall increase in life expectancy and improvement in diabetes management and treatment of complications. They are a heterogeneous cohort due to the dynamic process of aging and the presence of comorbidities and diabetes-related complications. A high risk for hypoglycemia unawareness and severe hypoglycemia has been described. Periodic assessment of health status and adjustment of glycemic goals to mitigate hypoglycemia is imperative. Continuous glucose monitoring, insulin pump, and hybrid closed-loop systems are promising tools to improve glycemic control and mitigate hypoglycemia in this age group.

Use of Telemedicine in Adults with Type 1 Diabetes: Do Age and Use of Diabetes-Related Technology Matter?

Objective: Older adults are generally less proficient in technology use compared with younger adults. Data on telemedicine use during the COVID-19 pandemic in older persons with type 1 diabetes (T1D) and the association of telemedicine with the use of diabetes-related technology are limited. We evaluated care delivery to older adults compared with younger adults with T1D in a prepandemic and pandemic period. Methods: Data from electronic health records were evaluated for visit types (in-person, phone, and video) from two sequential 12-month intervals: prepandemic (April 2019-March 2020) and pandemic (April 2020-March 2021). Results: Data from 2,832 unique adults with T1D were evaluated in two age cohorts: younger (40-64 years) and older (≥65 years). Half of each group used continuous glucose monitoring (CGM), whereas 54% of the younger and 37% of the older cohort used pump therapy (p < 0.001). During the pandemic compared with the prepandemic period, visit frequency increased in both the younger (0.65 vs. 0.76 visits/patient/quarter; p < 0.01) and older (0.72 vs. 0.80 visits/patient/quarter; p < 0.01) cohorts. During the pandemic, older adults used more phone visits compared with younger adults (48% vs. 32%; p = 0.001). Patients using either pump therapy or CGM were more likely to use video visits compared with phone visits in both younger (41% vs. 24%; p < 0.001) and older cohorts (53% vs. 42%; p < 0.001). Conclusions: Adults using diabetes-related technologies, independent of age, accessed more video visits than those not using devices. Telemedicine visits appeared to maintain continuity of care for younger and older adults with T1D, supporting the future of a hybrid-care model.

Use of Telecommunication and Diabetes-Related Technologies in Older Adults With Type 1 Diabetes During a Time of Sudden Isolation: Mixed Methods Study.

BACKGROUND: The COVID-19 lockdown imposed a sudden change in lifestyle with self-isolation and a rapid shift to the use of technology to maintain clinical care and social connections. OBJECTIVE: In this mixed methods study, we explored the impact of isolation during the lockdown on the use of technology in older adults with type 1 diabetes (T1D). METHODS: Older adults (aged ≥65 years) with T1D using continuous glucose monitoring (CGM) participated in semistructured interviews during the COVID-19 lockdown. A multidisciplinary team coded the interviews. In addition, CGM metrics from a subgroup of participants were collected before and during the lockdown. RESULTS: We evaluated 34 participants (mean age 71, SD 5 years). Three themes related to technology use emerged from the thematic analysis regarding the impact of isolation on (1) insulin pump and CGM use to manage diabetes, including timely access to supplies, and changing Medicare eligibility regulations; (2) technology use for social interaction; and (3) telehealth use to maintain medical care. The CGM data from a subgroup (19/34, 56%; mean age 74, SD 5 years) showed an increase in time in range (mean 57%, SD 17% vs mean 63%, SD 15%; P=.001), a decrease in hyperglycemia (>180 mg/dL; mean 41%, SD 19% vs mean 35%, SD 17%; P<.001), and no change in hypoglycemia (<70 mg/dL; median 0.7%, IQR 0%-2% vs median 1.1%, IQR 0%-4%; P=.40) during the lockdown compared to before the lockdown. CONCLUSIONS: These findings show that our cohort of older adults successfully used technology during isolation. Participants provided the positive and negative perceptions of technology use. Clinicians can benefit from our findings by identifying barriers to technology use during times of isolation and developing strategies to overcome these barriers.

Toward A Regulatory Pathway for the Use of in Silico Trials in the CE Marking of Medical Devices.

In Silico Trials methodologies will play a growing and fundamental role in the development and de-risking of new medical devices in the future. While the regulatory pathway for Digital Patient and Personal Health Forecasting solutions is clear, it is more complex for In Silico Trials solutions, and therefore deserves a deeper analysis. In this position paper, we investigate the current state of the art towards the regulatory system for in silico trials applied to medical devices while exploring the European regulatory system toward this topic. We suggest that the European regulatory system should start a process of innovation: in principle to limit distorted quality by different internal processes within notified bodies, hence avoiding that the more innovative and competitive companies focus their attention on the needs of other large markets, like the USA, where the use of such radical innovations is already rapidly developing.

Drugs and convalescent plasma therapy for COVID-19: a survey of the interventional clinical studies in Italy after 1 year of pandemic.

BACKGROUND: The 2019 novel coronavirus disease (COVID-19) pandemic has highlighted the importance of health research and fostered clinical research as never before. A huge number of clinical trials for potential COVID-19 interventions have been launched worldwide. Therefore, the effort of monitoring and characterizing the ongoing research portfolio of COVID-19 clinical trials has become crucial in order to fill evidence gaps that can arise, define research priorities and methodological issues, and eventually, formulate valuable recommendations for investigators and sponsors. The main purpose of the present work was to analyze the landscape of COVID-19 clinical research in Italy, by mapping and describing the characteristics of planned clinical trials investigating the role of drugs and convalescent plasma for treatment or prevention of COVID-19 disease. METHODS: During an 11-month period between May 2020 and April 2021, we performed a survey of the Italian COVID-19 clinical trials on therapeutic and prophylactic drugs and convalescent plasma. Clinical trials registered in the Italian Medicines Agency (AIFA) and ClinicalTrials.gov websites were regularly monitored. In the present paper, we report an analysis of study design characteristics and other trial features at 6 April 2021. RESULTS: Ninety-four clinical trials planned to be carried out in Italy were identified. Almost all of them (91%) had a therapeutic purpose; as for the study design, the majority of them adopted a parallel group (74%) and randomized (76%) design. Few of them were blinded (33%). Eight multiarm studies were identified, and two of them were multinational platform trials. Many therapeutic strategies were investigated, mostly following a drug repositioning therapeutic approach. CONCLUSIONS: Our study describes the characteristics of COVID-19 clinical trials planned to be carried out in Italy over about 1 year of pandemic emergency. High level quality clinical trials were identified, although some weaknesses in study design and replications of experimental interventions were observed, particularly in the early phase of the pandemic. Our findings provide a critical view of the clinical research strategies adopted for COVID-19 in Italy during the early phase of the pandemic. Further actions could include monitoring and follow-up of trial results and publications and focus on non-pharmacological research areas.

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.

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

AIMS/HYPOTHESIS: Problematic 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. METHODS: We 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). RESULTS: The 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/INTERPRETATION: The 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.

Hypoglycemia Subtypes in Type 1 Diabetes: An Exploration of the Hypoglycemia Fear Survey-II.

OBJECTIVE: The Hypoglycemia Fear Survey-II (HFS-II) is a well-validated measure of fear of hypoglycemia in people with type 1 diabetes. The aim of this study was to explore the relationships between hypoglycemia worries, behaviors, and cognitive barriers to hypoglycemia avoidance and hypoglycemia awareness status, severe hypoglycemia, and HbA1c. RESEARCH DESIGN AND METHODS: Participants with type 1 diabetes (n = 178), with the study population enriched for people at risk for severe hypoglycemia (49%), completed questionnaires for assessing hypoglycemia fear (HFS-II), hyperglycemia avoidance (Hyperglycemia Avoidance Scale [HAS]), diabetes distress (Problem Areas In Diabetes [PAID]), and cognitive barriers to hypoglycemia avoidance (Attitudes to Awareness of Hypoglycemia [A2A]). Exploratory factor analysis was applied to the HFS-II. We sought to establish clusters based on HFS-II, A2A, Gold, HAS, and PAID using k-means clustering. RESULTS: Four HFS-II factors were identified: Sought Safety, Restricted Activity, Ran High, and Worry. While Sought Safety, Restricted Activity, and Worry increased with progressively impaired awareness and recurrent severe hypoglycemia, Ran High did not. With cluster analysis we outlined four clusters: two clusters with preserved hypoglycemia awareness were differentiated by low fear/low cognitive barriers to hypoglycemia avoidance (cluster 1) versus high fear and distress and increased Ran High behaviors (cluster 2). Two clusters with impaired hypoglycemia awareness were differentiated by low fear/high cognitive barriers (cluster 3) as well as high fear/low cognitive barriers (cluster 4). CONCLUSIONS: This is the first study to define clusters of hypoglycemia experience by worry, behaviors, and cognitive barriers to hypoglycemia avoidance. The resulting subtypes may be important in understanding and treating problematic hypoglycemia.

Impact of Diabetes Duration on Functional and Clinical Status in Older Adults With Type 1 Diabetes.

OBJECTIVE: Adults with type 1 diabetes (T1D) are aging successfully. The impact of diabetes duration on clinical and functional status as people age with T1D is not well known. RESEARCH DESIGN AND METHODS: We performed a cross-sectional study of older adults (age ≥65 years) with T1D. RESULTS: We evaluated 165 older adults, mean age 70 ± 10 years. After adjustment for age, sex, and A1C, longer duration of T1D, ≥50 years, was associated with a higher likelihood of depression (odds ratio [OR] 2.8; P = 0.008), hypoglycemia unawareness (OR 2.6; P = 0.01), lower scores on 6-Minute Walk Test (OR 0.99; P = 0.01) and the Physical Component Summary (PCS) of Short Form-36 (SF-36) (OR 0.96; P = 0.02), and greater daily medication use (OR 1.1; P = 0.004) compared with those with duration <50 years. CONCLUSIONS: In older adults with T1D, duration of diabetes impacts clinical and functional status, independent of age and glycemic control, and should be considered in development of management strategies for safety and success.

Can Smart Pens Help Improve Diabetes Management?

Smart pen technology has evolved over the past decade with new features such as Bluetooth connectivity, bolus dose calculators, and integration with mobile apps and continuous glucose monitors. While similar in appearance to a traditional insulin pen, smart pens have the ability to record and store data of insulin injections. These devices have the potential to transform diabetes management for clinicians, and patients with type 1 and type 2 diabetes on insulin therapy by improving adherence, glycemic control, and addressing barriers to diabetes management. Smart pens can also highlight the relationship between insulin, food, and physical activity, and provide insight into optimizing insulin regimens. Education of clinicians and patients, and more clinical studies showing the benefits of smart pens and cost-effectiveness, are needed.

Caring for Young Adults With Diabetes in the Adult Care Setting: Summary of a Multidisciplinary Roundtable.

Aims: A multidisciplinary team of clinicians and researchers, patients and family members, and representative from national advocacy groups and research organization met to review the literature, highlight gaps, and identify best practices to improve adult care delivery for young adults (YA) with diabetes. Methods: The participants prepared presentations in advance, rotated through sessions, and contributed to group discussions in three areas: physical health, mental health, and quality of life (QoL). Session moderators and scribes used thematic analysis to summarize discussions for each topic. Results: Thematic analysis revealed four foci for addressing physical health, mental health and QoL: 1) best practices to facilitate the process of transfer; 2) age-specific curricula and guidelines for prevention and management of comorbidities and complications; 3) collaboration with behavioral health clinicians to address diabetes distress and mental health disorders; and 4) research on the impact of diabetes on QoL in YA. Conclusion: There was substantial interest and need among adult clinicians to work in concert with pediatric and mental health professionals to identify best practices and future directions to improve healthcare process and diabetes-related outcome measures in YA with diabetes.

Closed-Loop Insulin Therapy in Older Adults with Type 1 Diabetes: Real-World Data.

Objective: To assess the impact of initiation of closed-loop control (CLC) on glycemic metrics in older adults with type 1 diabetes (T1D) in the real world. Methods: Retrospective analysis of electronic health records from a single tertiary diabetes center of older adults prescribed CLC between January and December 2020. Results: Forty-eight patients (mean age 70 ± 4 years, T1D duration 42 ± 14 years) were prescribed CLC and 39/48 started on the CLC. Among the CLC starters, 97.5% and 95% were prior pump and continuous glucose monitoring (CGM) users, respectively. CGM metrics showed an increase in time-in-range (62% ± 13% to 76% ± 9%; P < 0.001), a reduction in both time spent <70 mg/dL [2% (1%-3%) to 1% (1%-2%); P = 0.03] and >180 mg/dL (30% ± 11% to 20% ± 9%; P < 0.001) at 3 months. Conclusion: In this real-world data most of the older patients with T1D initiating CLC were prior pump and CGM users. Initiation of CLC improved glycemic control and reduced time spent in hypoglycemia compared with prior therapy.