Automating insulin delivery through pump and continuous glucose monitoring connectivity: Maximizing opportunities to improve outcomes.

The development of automated insulin delivery (AID) systems, which connect continuous glucose monitoring (CGM) systems with algorithmic insulin delivery from an insulin pump (continuous subcutaneous insulin infusion, [CSII]), has led to improved glycaemia and quality of life benefits in those with insulin-treated diabetes. This review summarizes the benefits gained by the connectivity between insulin pumps and CGM devices. It details the technical requirements and advances that have enabled this, and highlights the clinical and user benefits of such systems. Clinical trials and real-world outcomes from the use of AID systems in people with type 1 diabetes (T1D) will be the focus of this article; outcomes in people with type 2 diabetes (T2D) and other diabetes subtypes will also be discussed. We also detail the limitations of current technological approaches for connectivity between insulin pumps and CGM devices. While recognizing the barriers, we discuss opportunities for the future.

Socio-economic disparities in hospital care among Dutch patients with diabetes mellitus.

AIM: Socio-economic status (SES) influences diabetes onset, progression and treatment. In this study, the associations between SES and use of hospital care were assessed, focusing on hospitalizations, technology and cardiovascular complications. MATERIALS AND METHODS: This was an observational cohort study comprising 196 695 patients with diabetes (all types and ages) treated in 65 hospitals across the Netherlands from 2019 to 2020 using reimbursement data. Patients were stratified in low, middle, or high SES based on residential areas derived from four-digit zip codes. RESULTS: Children and adults with low SES were hospitalized more often than patients with middle or high SES (children: 22%, 19% and 15%, respectively; p < .001, adults: 28%, 25% and 23%; p < .001). Patients with low SES used the least technology: no technology in 48% of children with low SES versus 40% with middle SES and 38% with high SES. In children, continuous subcutaneous insulin infusion (CSII) and real-time continuous glucose monitoring (rtCGM) use was higher in high SES {CSII: odds ratio (OR) 1.54 [95% confidence interval (CI) 1.35-1.76]; p < .001; rtCGM OR 1.39 [95% CI 1.20-1.61]; p < .001} and middle SES [CSII: OR 1.41 (95% CI 1.24-1.62); p < .001; rtCGM: OR 1.27 (95% CI 1.09-1.47); p = .002] compared with low SES. Macrovascular (OR 0.78 (95% CI 0.75-0.80); p < .001) and microvascular complications [OR 0.95 (95% CI 0.93-0.98); p < .001] occurred less in high than in low SES. CONCLUSIONS: Socio-economic disparities were observed in patients with diabetes treated in Dutch hospitals, where basic health care is covered. Patients with low SES were hospitalized more often, used less technology, and adults with high SES showed fewer cardiovascular complications. These inequities warrant attention to guarantee equal outcomes for all.

Automated insulin delivery: benefits, challenges, and recommendations. A Consensus Report of the Joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association.

A technological solution for the management of diabetes in people who require intensive insulin therapy has been sought for decades. The last 10 years have seen substantial growth in devices that can be integrated into clinical care. Driven by the availability of reliable systems for continuous glucose monitoring, we have entered an era in which insulin delivery through insulin pumps can be modulated based on sensor glucose data. Over the past few years, regulatory approval of the first automated insulin delivery (AID) systems has been granted, and these systems have been adopted into clinical care. Additionally, a community of people living with type 1 diabetes has created its own systems using a do-it-yourself approach by using products commercialised for independent use. With several AID systems in development, some of which are anticipated to be granted regulatory approval in the near future, the joint Diabetes Technology Working Group of the European Association for the Study of Diabetes and the American Diabetes Association has created this consensus report. We provide a review of the current landscape of AID systems, with a particular focus on their safety. We conclude with a series of recommended targeted actions. This is the fourth in a series of reports issued by this working group. The working group was jointly commissioned by the executives of both organisations to write the first statement on insulin pumps, which was published in 2015. The original authoring group was comprised by three nominated members of the American Diabetes Association and three nominated members of the European Association for the Study of Diabetes. Additional authors have been added to the group to increase diversity and range of expertise. Each organisation has provided a similar internal review process for each manuscript prior to submission for editorial review by the two journals. Harmonisation of editorial and substantial modifications has occurred at both levels. The members of the group have selected the subject of each statement and submitted the selection to both organisations for confirmation.

Identifying patients with type 2 diabetes who might benefit from insulin pump therapy: Literature review, clinical opportunities, potential benefits and challenges.

The global prevalence and increasing incidence rates of type 2 diabetes (T2D) have rippling effects on healthcare costs and diminishing quality of life. Despite advances in technology, continuous subcutaneous insulin infusion (CSII), or insulin pump therapy, is rarely being recommended by healthcare professionals and is underutilized in T2D management. This review analyses the available literature on CSII use in T2D patients. In addition, it discusses which groups of patients may benefit from CSII, identifies potential challenges associated with CSII use, and suggests future directions for research to expand the applicability of this technology to the broader T2D population.

Changes in the glycaemia risk index and its association with other continuous glucose monitoring metrics after initiation of an automated insulin delivery system in adults with type 1 diabetes.

AIM: To evaluate the glycaemia risk index (GRI) and its association with other continuous glucose monitoring (CGM) metrics after initiation of an automated insulin delivery (AID) system in patients with type 1 diabetes (T1D). MATERIALS AND METHODS: Up to 90 days of CGM data before and after initiation of an AID system from 185 CGM users with T1D were collected. GRI and other CGM metrics were calculated using cgmanalysis R software and were analysed for 24 hours, for both night-time and daytime. GRI values were assigned to five GRI zones: zone A (0-20), B (21-40), C (41-60), D (61-80) and E (81-100). RESULTS: Compared with baseline, GRI and its components decreased significantly after AID initiation (GRI: 48.7 ± 21.8 vs. 29 ± 13; hypoglycaemia component: 2.7 ± 2.8 vs. 1.6 ± 1.7; hyperglycaemia component: 25.3 ± 14.5 vs. 15 ± 8.5; P < .001 for all). The GRI was inversely correlated with time in range before (r = -0.962) and after (r = -0.961) AID initiation (P < .001 for both). GRI was correlated with time above range (before: r = 0.906; after = 0.910; P < .001 for both), but not with time below range (P > .05). All CGM metrics improved after AID initiation during 24 hours, for both daytime and night-time (P < .001 for all). Metrics improved significantly more during night-time than daytime (P < .01). CONCLUSIONS: GRI was highly correlated with various CGM metrics above, but not below target range, both before and after AID initiation.

Use of insulin pumps and closed-loop systems among people living with diabetes: A narrative review of clinical and cost-effectiveness to enable access to technology and meet the needs of payers.

The use of continuous subcutaneous insulin infusion (CSII) via insulin pumps is today considered standard of care for type 1 diabetes (T1D). Closed-loop systems combining continuous glucose monitoring with automated algorithm-driven insulin delivery have been shown to be safe and efficacious in randomized controlled trials and real-life studies in both paediatric and adult participants with T1D. Implementation of hybrid closed-loop (HCL) systems has shown incremental effectiveness, with further reduction of hypoglycaemia and hyperglycaemia. Although less extensively studied in type 2 diabetes (T2D), insulin pumps have demonstrated their effectiveness in glucose control, along with a reduction in need for insulin and a neutral effect on weight. Recent studies have also shown promising results with the use of HCL systems in T2D. Cost-effectiveness studies in both T1D and T2D have shown that pump use is cost-effective in several countries, leading to improvements in quality-adjusted life-years. Insulin pumps are currently reimbursed for T1D in many European countries, but in only a few for individuals with T2D. HCL systems are to be evaluated in future trials performed in T2D to compare their incremental efficacy and cost-effectiveness in comparison with available intensification tools which include multiple daily insulin injections, metformin, sodium-glucose cotransporter-2 inhibitors and glucagon-like peptide-1 receptor agonists. There is a need for updated guidelines for the use of CSII and HCL in individuals living with T2D based on the emerging evidence, with identification of and recommendations for the people who would benefit the most, which would eventually form a basis for reimbursement and health policies.

Diabetes and pregnancy study (DAPSY): a 10-year single-center cohort study of pregnancies affected by diabetes.

PURPOSE: The aim of our study was to investigate to what degree clinical characteristics can contribute to incidence and structure of pregnancy and childbirth complications in women with diabetes, and to reveal key risk factors for adverse outcomes. METHODS: We conducted a retrospective single-center cohort study from January 2008 through December 2017, including 3069 singleton pregnancies, affected by type 1 diabetes (T1D, n = 498), type 2 diabetes (T2D, n = 214), and gestational diabetes mellitus (GDM, n = 2357). RESULTS: More than 10 years duration of T1D associated with increased risk for preterm birth (RR 2.03, 95% CI 1.28-3.20) and preeclampsia (RR 1.57, 95% CI 1.09-2.26). Diabetic nephropathy, same as diabetic proliferative retinopathy, was associated with increased risk of C-section, preeclampsia development, SGA delivery. In patients with T1D who received CSII (12%), we do not report superior outcomes compared to MDI. Pre-pregnancy HbA1c level less than 6.5% reduced the risk of preeclampsia for T1D (RR 0.28, 95% CI 0.19-0.67) and risk of LGA birth for T2D (RR 0.43, 95% CI 0.19-0.92). Achieving glycemic target values by full-term pregnancy reduced the risk of excessive fetal adiposity (RR 0.81 for T1D, RR 0.39 for T2D). For T2D and GDM, the leading risk factors were obesity and chronic hypertension. For patients with GDM, insulin administration and early diagnosis of GDM were the significant risk factors for adverse outcomes. CONCLUSION: Diabetes during pregnancy is challenging for the clinician, but optimizing glycemic control, treatment regimens, and close attention to comorbidities can help to reduce the risks and ensure appropriate quality diabetes management.

Current provision and HCP experiences of remote care delivery and diabetes technology training for people with type 1 diabetes in the UK during the COVID-19 pandemic.

BACKGROUND: The COVID-19 pandemic has led to the rapid implementation of remote care delivery in type 1 diabetes. We studied current modes of care delivery, healthcare professional experiences and impact on insulin pump training in type 1 diabetes care in the United Kingdom (UK). METHODS: The UK Diabetes Technology Network designed a 48-question survey aimed at healthcare professionals providing care in type 1 diabetes. RESULTS: One hundred and forty-three healthcare professionals (48% diabetes physicians, 52% diabetes educators and 88% working in adult services) from approximately 75 UK centres (52% university hospitals, 46% general and community hospitals), responded to the survey. Telephone consultations were the main modality of care delivery. There was a higher reported time taken for video consultations versus telephone (p < 0.001). Common barriers to remote consultations were patient familiarity with technology (72%) and access to patient device data (67%). We assessed the impact on insulin pump training. A reduction in total new pump starts (73%) and renewals (61%) was highlighted. Common barriers included patient digital literacy (61%), limited healthcare professional experience (46%) and time required per patient (44%). When grouped according to size of insulin pump service, pump starts and renewals in larger services were less impacted by the pandemic compared to smaller services. CONCLUSION: This survey highlights UK healthcare professional experiences of remote care delivery. While supportive of virtual care models, a number of factors highlighted, especially patient digital literacy, need to be addressed to improve virtual care delivery and device training.

Feasibility study of a prototype extended-wear insulin infusion set in adults with type 1 diabetes.

AIM: To assess the feasibility of a prototype insulin infusion set (IIS) for extended wear in adults with type 1 diabetes. MATERIALS AND METHODS: The prototype Capillary Biomedical investigational extended-wear IIS (CBX IIS) incorporates a soft, flexible, reinforced kink-resistant angled nylon-derivative cannula with one distal and three proximal ports to optimize insulin delivery. Twenty adult participants with type 1 diabetes established on insulin pump therapy used the CBX IIS for two 7-day test periods while wearing a Dexcom G5 continuous glucose monitor. RESULTS: Participants were able to wear the CBX IIS for an average of 6.6 ± 1.4 days. Eighty-eight percent (36 of 41) of sets were worn for 7 days. No serious adverse events were reported. Five infusion sets failed prematurely because of: unresolvable hyperglycaemia (three); hyperglycaemia with elevated ketones (one); or infection (one). Median time in range (3.9-10.0 mmol/L) was 62% (54-76). Average glucose levels per day of infusion set wear showed a statistically significant increase over time (p < .001). CONCLUSIONS: Our preliminary observations confirm the tolerability of the prototype CBX IIS for extended wear, albeit with a deterioration in glucose control after the third day.

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.

AIM: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Insulin induces a progressive increase in the resistance of subcutaneous tissue to fluid flow: Implications for insulin pump therapy.

AIM: To determine the effect of insulin on the resistance of subcutaneous tissue to the flow of infusion fluids. MATERIALS AND METHODS: Thirty subjects with type 1 diabetes wore two Accu-Chek Spirit Combo insulin pumps with Accu-Chek FlexLink infusion sets (Roche Diabetes Care, Mannheim, Germany) for 7 days. One pump was filled with insulin aspart (Novo Nordisk, Bagsvaerd, Denmark) and used for continuous subcutaneous insulin infusion (CSII). The other pump was filled with insulin diluting medium (IDM; Novo Nordisk) and used to deliver IDM subcutaneously at rates identical to those employed for CSII. Both infusion sites were assessed daily by measuring the pressure required to infuse various bolus amounts of IDM. RESULTS: On day 1, maximum pressure (Pmax ) and tissue flow resistance (TFR; calculated from measured pressure profiles) were similar for both infusion sites (P > 0.20). During the subsequent study days, the Pmax and TFR values observed at the IDM infusion site remained at levels comparable to those seen on day 1 (P > 0.13). However, at the site of CSII, Pmax and TFR progressively increased with CSII duration. By the end of day 7, Pmax and TFR reached 25.8 */2.11 kPa (geometric mean */geometric standard deviation) and 8.64 */3.48 kPa*s/µL, respectively, representing a remarkable 3.5- and 20.6-fold increase relative to the respective Pmax and TFR values observed on day 1 (P < 0.001). CONCLUSION: Our results suggest that insulin induces a progressive increase in the resistance of subcutaneous tissue to the introduction of fluid; this has important implications for the future design of insulin pumps and infusion sets.

Three-variate trajectories of metabolic control, body mass index, and insulin dose: Heterogeneous response to initiation of pump therapy in youth with type 1 diabetes.

OBJECTIVE: Continuous subcutaneous insulin infusion (CSII) in youths with type 1 diabetes (T1D) is often associated with lower HbA1c, lower total daily insulin dose (TDD), and lower body mass index (BMI) compared with multiple daily injections (MDI). Individual responses to CSII are diverse. The aim was to identify unique three-variate patterns of HbA1c, BMI standard deviation score (SDS), and TDD after switching to CSII. METHODS: Five thousand one hundred and thirty-three youths (≤20 years; 48% boys; median age at pump start 12.5 years) with T1D duration ≥3 years at CSII initiation were selected from the multicenter DPV registry. We applied group-based multitrajectory modeling to identify groups of individuals following similar trajectories. Measurements were aggregated quarterly during a 3-year follow-up period. Trajectory variables were changes of HbA1c, BMI-SDS, and TDD from baseline (delta = quarterly aggregated values at each time point [i] minus the respective baseline value). RESULTS: Four groups of diverging Delta-HbA1c, Delta-BMI-SDS, and Delta-TDD patterns were identified. All showed improvements in HbA1c during the first 3 months. Group 1 (12%) was characterized by modest HbA1c increase thereafter, TDD reduction, and stable BMI-SDS. In Group 2 (39%), increasing HbA1c, decreasing BMI-SDS, and stable TDD were found. By contrast, sustainably improved HbA1c, increasing BMI-SDS, and stable TDD were observed in Group 3 (32%). Group 4 (17%) was characterized by increasing levels for HbA1c, BMI-SDS, and TDD. Between-group differences in baseline HbA1c, BMI-SDS, TDD as well as in sex ratio, age at diabetes onset and at pump start were observed. CONCLUSIONS: Definite trajectories of glycemic control, BMI, and TDD over 3 years after CSII initiation were identified in youths with T1D allowing a more personalized treatment recommendation.

A simulator with realistic and challenging scenarios for virtual T1D patients undergoing CSII and MDI therapy.

In silico simulations have become essential for the development of diabetes treatments. However, currently available simulators are not challenging enough and often suffer from limitations in insulin and meal absorption variability, which is unable to realistically reflect the dynamics of people with type 1 diabetes (T1D). Additionally, T1D simulators are mainly designed for the testing of continuous subcutaneous insulin infusion (CSII) therapies. In this work, a simulator is presented that includes a generated virtual patient (VP) cohort and both fast- and long-acting Glargine-100 U/ml (Gla-100), Glargine-300 U/ml (Gla-300), and Degludec-100 U/ml (Deg-100) insulin models. Therefore, in addition to CSII therapies, multiple daily injections (MDI) therapies can also be tested. The Hovorka model and its published parameter probability distributions were used to generate cohorts of VPs that represent a T1D population. Valid patients are filtered through restrictions that guarantee that they are physiologically acceptable. To obtain more realistic scenarios, basal insulin profile patterns from the literature have been used to identify variability in insulin sensitivity. A library of mixed meals identified from real data has also been included. This work presents and validates a methodology for the creation of realistic VP cohorts that include physiological variability and a simulator that includes challenging and realistic scenarios for in silico testing. A cohort of 47 VPs has been generated and in silico simulations of both CSII and MDI therapies were performed in open-loop. The simulation outcome metrics were contrasted with literature results.

Health care organization and use of technological devices in people with diabetes in Italy: Results from a survey of the Working Group on Diabetes and Technology.

BACKGROUND AND AIM: The use of technology offers recognized benefits to persons with diabetes. The aim of this study was to evaluate the organization of healthcare facilities, the composition of the diabetes team, and the use of Continuous Subcutaneous Insulin Infusion (CSII) and Continuous Glucose Monitoring (CGM) in Italy. METHODS AND RESULTS: Diabetes care centers were asked to complete a web survey based on information collected in 2018. Sixty-one pediatric and 243 adult centers participated in the survey, accounting for 507,386 patients, mostly with type 2 diabetes (86.4%). Fifty-three percent of pediatric centers and 11% of adult centers reported a team composed of diabetologists, nurses, and psychologists. Overall, 13,204 patients (2.6%) were using CSII (95% with type 1 diabetes), and 28,936 (5.7%), were using CGM (74% with type 1 diabetes). When stratifying for the type of diabetes, 24% and 40.8% of patients with type 1 were using CSII and CGM, respectively, whereas low use of technology was reported for patients with type 2 and women with gestational diabetes. The percentage of adult and pediatric patients with type 1 diabetes on CSII and CGM was respectively 21% and 32%, and 35% and 57%. CONCLUSIONS: The spread of CGM and CSII increased in Italy between 2013 and 2018. However, the percentage of users is still lower than what is expected based on clinical indications for use of technology. The inadequate number of professionals in the diabetes care team and insufficient economic resources are relevant barriers to disseminating technology for diabetes management.

Glucose control in home-isolated adults with type 1 diabetes affected by COVID-19 using continuous glucose monitoring.

PURPOSE: This study is aimed at evaluating changes in metrics of glucose control in home-isolated patients with type 1 diabetes and COVID-19 using a continuous glucose monitoring (CGM) system. METHODS: We included adults aged 18-45 years with type 1 diabetes, using CGM, followed by telemedicine at a Southern Italian University Hospital. Thirty-two home-quarantined subjects with SARS-CoV-2 positive swab constituted the COVID-19 group. Thirty age-matched diabetic individuals without COVID-19 formed the control group. The effects of COVID-19 on glycemic control in patients infected were assessed at different time points [2 weeks before-COVID-19 (Time 1), 2 weeks during-COVID-19 (Time 2) and 2 weeks after COVID-19 (Time 3)] and compared with those without infection. RESULTS: A significant reduction of TIR (Time 1 vs Time 2, %, 60.1 ± 16.6 vs 55.4 ± 19.2, P = 0.03), associated with a significant increase of TAR level 2 (10.1 ± 7.3 vs 16.7 ± 12.9, P < 0.001), GMI (7.1 ± 0.6 vs 7.5 ± 0.8, P < 0.001), CV (37.3 ± 7.1 vs 39.6 ± 7.0, P = 0.04), mean glucose values (mg/dL, 160.2 ± 26.5 vs 175.5 ± 32.6, P = 0.001) and standard deviation (59.2 ± 13.1 vs 68.6 ± 17.7, P = 0.001) was observed in patients with COVID-19. No significant change of glycemic metrics was found in the NO COVID-19 group across the time. CONCLUSION: Young home-isolated patients with type 1 diabetes and COVID-19 showed a worsening of glucose control during COVID-19, as compared with age-matched diabetic subjects without the infection.

Survival assessment of the extended-wear insulin infusion set featuring lantern technology in adults with type 1 diabetes by the glucose clamp technique.

Maintaining good glycaemic control with the same infusion set for longer than 3 days may improve the quality of life of insulin pump users. The aim of the current study was to assess the efficacy and safety of the novel, extended-wear infusion set over 7 days of wear in adults with type 1 diabetes. Sixteen participants completed three identical 8-hour euglycaemic clamp experiments on Days 1, 4 and 7 of infusion set wear. Between the experiments, the participants were discharged home for routine diabetes management while wearing the same extended-wear infusion set throughout the study. Time to reach the maximum glucose infusion rate (TGIRmax ) on Day 7 was reduced by 67% compared with Day 1 (p < .001). The corresponding area under the glucose infusion rate curve (AUCGIR ) was comparable for the first 2 h of the clamp (p = .891) but decreased by 28% over time (p < .008). While the extent of insulin absorption decreased with prolonged wear, it was accompanied by an increase in insulin absorption rate. The infusion set survival rate was 100% without leakages, occlusion alarms, severe hypoglycaemia or ketoacidosis. The extended-wear infusion set proved safe and effective during prolonged wear in real-life conditions.

A randomized controlled trial of transition from insulin pump to multiple daily injections using insulin degludec.

AIM: To evaluate two methods of transition from an insulin pump to multiple daily injections (MDI) using long-acting insulin degludec (IDeg). MATERIALS AND METHODS: After a 1-week run-in period, adults with type 1 diabetes for longer than 1 year and HbA1c 48-69 mmol/mol (6.5%-8.5%), who had been using an insulin pump at least for 6 months, were randomly transitioned to either standard of care (discontinued insulin pump and started IDeg in 1:1 dose) or overlap (IDeg 1:1 at pump basal dose, but pump continued for the first 48 hours with a gradual basal reduction; 50% from 0-24 hours, 75% from 24-48 hours and then pump discontinued). Participants used blinded Dexcom G6 and the IDeg dose was not changed during the trial. Primary (% time above 180 mg/dL) and secondary (% time in 70-180 mg/dL and below 70 mg/dL) outcomes were compared between the two groups during 7 days of randomization. RESULTS: Age, gender, diabetes duration and basal/bolus insulin doses were similar between patients randomized to standard of care (n = 17) or overlap (n = 13) transition. Compared with overlap transition, the standard of care group spent 4.8% more time in hyperglycaemia (least square mean 4.8% [95% CI -3.3%, 12.9%]) and 5.3% less time in range (-5.3% [-12.6%, -2.0%]), without a significant difference in hypoglycaemia (0.5% [-2.3%,3.4%]). No treatment-related adverse events were noted in either group. CONCLUSION: The overlap transition method may result in a significant improvement in time-in-range without increasing hypoglycaemia during the first week of transition from an insulin pump to MDI using IDeg in adults with type 1 diabetes.

Real-world performance of hybrid closed loop in youth, young adults, adults and older adults with type 1 diabetes: Identifying a clinical target for hybrid closed-loop use.

AIM: To describe real-world hybrid closed loop (HCL) use and glycaemic outcomes across the lifespan and identify a clinical threshold for HCL use associated with meeting the internationally recommended target of 70% sensor glucose time in range (TIR; 70-180 mg/dL). MATERIALS AND METHODS: Mixed models examined MiniMed 670G HCL use and glycaemic outcomes in 276 people with type 1 diabetes from four age groups: youth (aged <18 years), young adults (18-25 years), adults (26-49 years) and older adults (≥50 years) for 1 year. ROC analysis identified the minimum percentage HCL use associated with meeting the TIR goal of 70%. RESULTS: HCL use at month 1 was 70.7% ± 2.9% for youth, 71.0% ± 3.8% for young adults, 78.9% ± 2.1% for adults and 84.7% ± 3.8% in older adults. HCL use declined significantly at 12 months to 49.3% ± 3.2% in youth (P < .001) and 55.7% ± 4.3% in young adults (P = .002). HCL use was sustained at 12 months in adults (76.4% ± 2.2%, P = .36) and older adults (80.4% ± 3.9%, P = .36). HCL use of 70.6% was associated with 70% TIR (sensitivity 58.3%, specificity 85%, AUC 0.77). Older age, 80% or higher continuous glucose monitor use and four or more blood glucose checks per day were associated with attaining the HCL-use threshold. CONCLUSIONS: HCL use of 70% or higher may be a useful target for clinicians to use to assist people with diabetes in attaining glycaemic goals. Youth may struggle with HCL use more than adults and require clinical intervention to help sustain HCL use across time.

Longevity of the novel ConvaTec infusion set with Lantern technology.

Current insulin infusion sets are approved for only 2-3 days. The novel ConvaTec infusion set with Lantern technology is designed to extend infusion set wear time. The goal of this pilot study was to evaluate the duration of wear for this set. This was a pilot safety study in adults with type 1 diabetes using tethered insulin pumps. Participants inserted the set and wore it for 10 days or until failure. Among 24 participants, two were excluded. Forty-five per cent of the sets lasted 10 days. Median wear time was 9.1 (7.1, 10.0) days. Among 12 premature failures, six (50%) involved adhesive failures, four (33%) hyperglycaemia unresponsive to correction, one (8%) hyperglycaemia with ketones and one (8%) infection. Average CGM glucose per day of infusion set wear showed a statistically significant increase over time, while total daily insulin over the same period did not change. In this pilot study, the duration of wear for the novel infusion set exceeded previously reported commercial sets (P < .001). This extended wear technology may eventually allow for a combined glucose sensor and infusion set.

Patient-reported outcomes in a study of human regular U-500 insulin delivered by continuous subcutaneous insulin infusion or multiple daily injections in patients with type 2 diabetes.

Human regular U-500 insulin (U-500R) provides both basal and prandial coverage to people with diabetes. As part of the VIVID study, we studied patient-reported outcomes (PRO) of U-500R delivered by multiple daily injections (MDI, n = 211) and continuous subcutaneous infusion using a novel U-500R pump (CSII, n = 209). Treatment-Related Impact Measure for Diabetes (TRIM-D) for Diabetes Device (TRIM-DD) questionnaires were administered at weeks 0, 14 and 26. TRIM scores with effect sizes (ES) for within-group and between-group change were reported. All TRIM-D scores significantly improved from baseline for both groups (P < .001). The Diabetes Management domain had the greatest improvement, 16.3 (ES = 0.85) and 10.6 (ES = 0.51) for CSII and MDI, respectively. At the study end, the CSII group had significantly higher TRIM-D scores than the MDI group (P < .05). Most TRIM-DD scores had small within-group improvements and were not different between groups. People with type 2 diabetes on U-500R by either CSII or MDI reported improvement in PRO, particularly in Diabetes Management, Treatment Burden and Psychological Health domains, with greater improvement in the CSII group. In terms of delivery device and function, the CSII and MDI methods were similarly acceptable.