Comparing Continuous Glucose Monitoring and Blood Glucose Monitoring in Adults With Inadequately Controlled, Insulin-Treated Type 2 Diabetes (Steno2tech Study): A 12-Month, Single-Center, Randomized Controlled Trial.

OBJECTIVE: To compare the 12-month effects of continuous glucose monitoring (CGM) versus blood glucose monitoring (BGM) in adults with insulin-treated type 2 diabetes. RESEARCH DESIGN AND METHODS: This is a single-center, parallel, open-label, randomized controlled trial including adults with inadequately controlled, insulin-treated type 2 diabetes from the outpatient clinic at Steno Diabetes Center Copenhagen, Denmark. Inclusion criteria were ≥18 years of age, insulin-treated type 2 diabetes, and HbA1c ≥7.5% (58 mmol/mol). Participants were randomly assigned (1:1) to 12 months of either CGM or BGM. All participants received a diabetes self-management education course and were followed by their usual health care providers. Primary outcome was between-group differences in change in time in range (TIR) 3.9-10.0 mmol/L, assessed at baseline, after 6 and 12 months by blinded CGM. The prespecified secondary outcomes were differences in change in several other glycemic, metabolic, and participant-reported outcomes. RESULTS: The 76 participants had a median baseline HbA1c of 8.3 (7.8, 9.1)% (67 [62-76] mmol/mol), and 61.8% were male. Compared with BGM, CGM usage was associated with significantly greater improvements in TIR (between-group difference 15.2%, 95% CI 4.6; 25.9), HbA1c (-0.9%, -1.4; -0.3 [-9.4 mmol/mol, -15.2; -3.5]), total daily insulin dose (-10.6 units/day, -19.9; -1.3), weight (-3.3 kg, -5.5; -1.1), and BMI (-1.1 kg/m2, -1.8; -0.3) and greater self-rated diabetes-related health, well-being, satisfaction, and health behavior. CONCLUSIONS: In adults with inadequately controlled insulin-treated type 2 diabetes, the 12-month impact of CGM was superior to BGM in improving glucose control and other crucial health parameters. The findings support the use of CGM in the insulin-treated subgroup of type 2 diabetes.

Lived Experience of Fully Closed-Loop Insulin Delivery in Adults with Type 1 Diabetes.

Introduction: The Closing the Loop in Adults With Type 1 Diabetes (CLEAR) randomized crossover study compared a novel fully closed-loop insulin delivery system with no carbohydrate entry or mealtime bolusing (CamAPS HX), with standard insulin pump therapy and glucose sensor in adults with type 1 diabetes and suboptimal glycemic outcomes. This qualitative substudy aimed to understand the psychosocial impact of using the fully automated system. Materials and Methods: Adults participating in the CLEAR study were invited to take part in a virtual semistructured interview after they had completed 8 weeks using the fully closed-loop system. Recruitment continued until there was adequate representation and data saturation occurred. Interviews were anonymized and transcribed for in-depth thematic analysis using an inductive-deductive approach. Study participants were also asked to complete questionnaires assessing diabetes distress, hypoglycemia confidence, and closed-loop treatment satisfaction. Results: Eleven participants (eight male and three female; age range 26-66 years) were interviewed. After an initial adjustment period, interviewees reported enjoying a reduction in diabetes burden, freed-up mental capacity, and improved mood. All were happy with overnight glycemic outcomes, with the majority reporting benefits on sleep. Although experiences of postprandial glucose outcomes varied, all found mealtimes easier and less stressful, particularly when eating out. Negatives raised by participants predominantly related to the insulin pump hardware, but some also reported increased snacking and challenges around resuming carbohydrate counting at trial closeout. Conclusions: In adults with type 1 diabetes, use of a fully closed-loop insulin delivery system had significant quality-of-life benefits and provided a welcome break from the day-to-day demands of living with diabetes. Clinical Trial Registration: NCT04977908.

Real-World Evidence of Automated Insulin Delivery System Use.

Objective: Pivotal trials of automated insulin delivery (AID) closed-loop systems have demonstrated a consistent picture of glycemic benefit, supporting approval of multiple systems by the Food and Drug Administration or Conformité Européenne mark receipt. To assess how pivotal trial findings translate to commercial AID use, a systematic review of retrospective real-world studies was conducted. Methods: PubMed and EMBASE were searched for articles published after 2018 with more than five nonpregnant individuals with type 1 diabetes (T1D). Data were screened/extracted in duplicate for sample size, AID system, glycemic outcomes, and time in automation. Results: Of 80 studies identified, 20 met inclusion criteria representing 171,209 individuals. Time in target range 70-180 mg/dL (3.9-10.0 mmol/L) was the primary outcome in 65% of studies, with the majority of reports (71%) demonstrating a >10% change with AID use. Change in hemoglobin A1c (HbA1c) was reported in nine studies (range 0.1%-0.9%), whereas four reported changes in glucose management indicator (GMI) with a 0.1%-0.4% reduction noted. A decrease in HbA1c or GMI of >0.2% was achieved in two-thirds of the studies describing change in HbA1c and 80% of articles where GMI was described. Time below range <70 mg/dL (<3.9 mmol/L) was reported in 16 studies, with all but 1 study showing stable or reduced levels. Most systems had >90% time in automation. Conclusion: With larger and more diverse populations, and follow-up periods of longer duration (∼9 months vs. 3-6 months for pivotal trials), real-world retrospective analyses confirm pivotal trial findings. Given the glycemic benefits demonstrated, AID is rapidly becoming the standard of care for all people living with T1D. Individuals should be informed of these systems and differences between them, have access to and coverage for these technologies, and receive support as they integrate this mode of insulin delivery into their lives.

Exercising Safely with the MiniMed™ 780G Automated Insulin Delivery System.

The physical and psychological benefits of exercise are particularly pertinent to people with type 1 diabetes (T1D). The variability in subcutaneous insulin absorption and the delay in offset and onset in glucose lowering action impose limitations, given the rapidly varying insulin requirements with exercise. Simultaneously, there are challenges to glucose monitoring. Consequently, those with T1D are less likely to exercise because of concerns regarding glucose instability. While glucose control with exercise can be enhanced using automated insulin delivery (AID), all commercially available AID systems remain limited by the pharmacokinetics of subcutaneous insulin delivery. Although glycemic responses may vary with exercises of differing intensities and durations, the principles providing the foundation for guidelines include minimization of insulin on board before exercise commencement, judicious and timely carbohydrate supplementation, and when possible, a reduction in insulin delivered in anticipation of planned exercise. There is an increasing body of evidence in support of superior glucose control with AID over manual insulin dosing in people in T1D who wish to exercise. The MiniMed™ 780G AID system varies basal insulin delivery with superimposed automated correction boluses. It incorporates a temporary (elevated glucose) target of 8.3 mmol/L (150 mg/dL) and when it is functioning, the autocorrection boluses are stopped. As the device has recently become commercially available, there are limited data assessing glucose control with the MiniMed™ 780G under exercise conditions. Importantly, when exercise was planned and implemented within consensus guidelines, %time in range and %time below range targets were met. A practical approach to exercising with the device is provided with illustrative case studies. While there are limitations to spontaneity imposed on any AID device due to the pharmacokinetics associated with the subcutaneous delivery of current insulin formulations, the MiniMed™ 780G system provides people with T1D an excellent option for exercising safely if the appropriate strategies are implemented.

Removing Barriers, Bridging the Gap, and the Changing Role of the Health Care Professional with Automated Insulin Delivery Systems.

As all people with type 1 diabetes (T1D) and some with type 2 diabetes (T2D) require insulin, there is a need to develop management methods that not only achieve glycemic targets but also reduce the burden of living with diabetes. After insulin pumps and continuous glucose monitors, the next step in the evolution of diabetes technology is automated insulin delivery (AID) systems, which have transformed intensive insulin management over the past decade, as these systems address the shortcomings of previous management options. However, AID use remains fairly limited, and access represents a major barrier to use for many people with diabetes, despite these systems being standard of care. Therefore, the future of AID will necessitate addressing barriers related to social determinants of health, finances, and an expansion of the number and type of health care professionals (HCPs) prescribing AID systems. These crucial steps will be essential to ensure that everyone with intensively managed diabetes can use AID systems. The impact of implementing these changes will create a shift in the future of diabetes care that will result in achievement of more targeted glycemia and psychosocial outcomes for all people with diabetes and an expansion of the role of all HCPs in AID-related diabetes care. Even more importantly, by addressing social determinants of health and clinical inertia related to AID, the field can address disparities in outcomes across countries, race, gender, socioeconomic status, and insurance status. Furthermore, the increased use of AID system will provide more time during appointments for a shift in the discussion away from fine tuning insulin dosing and toward a focus on more topics related to behavior and conversations about general health. This will include psychosocial outcomes, and quality of life. In addition, these changes can hopefully allow for time to discuss more general issues, such as cardiovascular health, obesity prevention, diabetes-related complications, and other health-related concerns.

The Health Economics of Automated Insulin Delivery Systems and the Potential Use of Time in Range in Diabetes Modeling: A Narrative Review.

Intensive therapy with exogenous insulin is the treatment of choice for individuals living with type 1 diabetes (T1D) and some with type 2 diabetes, alongside regular glucose monitoring. The development of systems allowing (semi-)automated insulin delivery (AID), by connecting glucose sensors with insulin pumps and algorithms, has revolutionized insulin therapy. Indeed, AID systems have demonstrated a proven impact on overall glucose control, as indicated by effects on glycated hemoglobin (HbA1c), risk of severe hypoglycemia, and quality of life measures. An alternative endpoint for glucose control that has arisen from the use of sensor-based continuous glucose monitoring is the time in range (TIR) measure, which offers an indication of overall glucose control, while adding information on the quality of control with regard to blood glucose level stability. A review of literature on the health-economic value of AID systems was conducted, with a focus placed on the growing place of TIR as an endpoint in studies involving AID systems. Results showed that the majority of economic evaluations of AID systems focused on individuals with T1D and found AID systems to be cost-effective. Most studies incorporated HbA1c, rather than TIR, as a clinical endpoint to determine treatment effects on glucose control and subsequent quality-adjusted life year (QALY) gains. Likely reasons for the choice of HbA1c as the chosen endpoint is the use of this metric in most validated and established economic models, as well as the limited publicly available evidence on appropriate methodologies for TIR data incorporation within conventional economic evaluations. Future studies could include the novel TIR metric in health-economic evaluations as an additional measure of treatment effects and subsequent QALY gains, to facilitate a holistic representation of the impact of AID systems on glycemic control. This would provide decision makers with robust evidence to inform future recommendations for health care interventions.

Decreasing the Burden of Carbohydrate Counting and Meal Announcement with Automated Insulin Delivery, Meal Recognition, and Autocorrection Doses: A Case Study.

The use of automated insulin delivery (AID) has led to a decrease in the burden of diabetes, allowing for better sleep, decreased anxiety about hypoglycemia, and automatic corrections doses, and meal recognition algorithms have provided "forgiveness" for imprecise carbohydrate (CHO) entries and missed or late meal boluses. We provide a case report and review of the current literature assessing the effect of AID on the burden of meal bolus. The case also demonstrates how sensor and pump data provide insight into insulin bolus behavior, and access to integrated cloud-based data has allowed for virtual patient visits. Glucose sensor metrics provides time in range and time below range, and the sensor-derived glucose management indicator provides an assessment of the long-term risk of complications when a laboratory glycated hemoglobin is not available.

A Diabetes Pregnancy Technology Roadmap: The 2023 Norbert Freinkel Award Lecture.

Norbert Freinkel emphasized the need for "more aggressive therapy with exogenous insulin" during type 1 diabetes (T1D) pregnancy. Recent advances in diabetes technology, continuous glucose monitoring (CGM), and hybrid closed-loop (HCL) insulin delivery systems allow us to revisit Freinkel's observations from a contemporary perspective. The Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT) led to international recommendations that CGM be offered to all pregnant women with T1D to help them meet their pregnancy glucose targets and improve neonatal outcomes. However, despite CGM use, only 35% of trial participants reached the pregnancy glucose targets by 35 weeks' gestation, which is too late for optimal obstetric and neonatal outcomes. The constant vigilance to CGM data and insulin dose adjustment, with perpetual worry about the impact of hyperglycemia on the developing fetal structures, leave many pregnant women feeling overwhelmed. HCL systems that can adapt to marked gestational changes in insulin sensitivity and pharmacokinetics may help to bridge the gap between the nonpregnant time in range glycemic targets (70-180 mg/dL) and the substantially more stringent pregnancy-specific targets (TIRp) (63-140 mg/dL) required for optimal obstetric and neonatal outcomes. Use of HCL (CamAPS FX system) was associated with a 10.5% higher TIRp, 10.2% less hyperglycemia, and 12.3% higher overnight TIRp. Clinical benefits were accompanied by 3.7 kg (8 lb) less gestational weight gain and consistently achieved across a representative patient population of insulin pump or injection users, across trial sites, and across maternal HbA1c categories. Working collaboratively, women, HCL technology, and health care teams achieved improved glycemia with less worry, less work, and more positive pregnancy experiences.

IDegLira for the real-world treatment of type 2 diabetes in Italy. Final results from the REX observational study.

AIM: The study was designed to generate real-world evidence on IDegLira in the Italian clinical practice in two groups of patients with type 2 diabetes (T2D), switching to IDegLira either from a basal only (basal group) or basal-bolus insulin regimen (BB group). MATERIALS AND METHODS: This was a non-interventional, multicentre, single-cohort, prospective study assessing the long-term glycaemic control in patients with T2D, who switched to IDegLira from a basal insulin ± glucose-lowering medication regimen with or without a bolus insulin component for approximately 18 months, conducted in 28 Italian diabetes centres. The primary endpoint was the change in glycated haemoglobin (HbA1c) levels from baseline to 6 months after IDegLira initiation. RESULTS: The study included 358 patients with a mean age 67.2 years and diabetes duration of 15.7 years. HbA1c significantly decreased from IDegLira start to all study time points in the overall population (basal group -1.19%; BB group -0.60% at the end of observation). Patients achieving HbA1c <7% levels increased from 12.9% (n = 43) to 40.3% (n = 110) at 18 months. Fasting blood glucose and body weight also significantly decreased in both groups, although more in the BB group. Overall, 14.3% of completed patients had an intensification of treatment (mainly in the basal group) and 48.6% had a simplification of treatment (mainly in the BB group). CONCLUSIONS: Switching to IDegLira in a real-world clinical setting is a valid therapeutic option for patients with T2D with inadequate glycaemic control on basal or BB insulin regimen and/or need to simplify their insulin therapy, with specific reasons and therapeutic goals according to different T2D management trajectories.

Closed-Loop Insulin Delivery May Help Prevent Metabolic Complications During Bariatric Surgery in Patients with Type 1 Diabetes: A Case Report.

Introduction: Obesity in patients with type 1 diabetes (T1D) may worsen their prognosis. Bariatric surgery in these patients can be associated with complications such as diabetic ketoacidosis and severe hypoglycemic episodes. Closed-loop insulin delivery could be a solution to avoid them. Case Report: A 45-year-old woman with T1D and obesity (body mass index of 38.4 kg/m2) was included in our preoperative course of bariatric surgery. Three months before surgery, a closed-loop insulin delivery was instituted due to one prior severe hypoglycemia. Patient did not have immediate or late postoperative hypoglycemia despite consuming a weak amount of carbohydrate. Three months after surgery glycemic control was on target with 86% of time in range 70-180 mg/dL and no time below 70 mg/dL. Conclusion: This case report shows that the use of a closed-loop insulin delivery made it possible to perform bariatric surgery in complete safety for our patient.

Real-world use of glucagon-like peptide-1 receptor agonists in youth with type 2 diabetes is associated with short-term improvements in HbA1c.

AIM: To assess the short-term, real-world use and effectiveness of glucagon-like peptide-1 receptor agonist (GLP-1RA) medications in the management of type 2 diabetes (T2D) in a diverse cohort of youth. METHODS: This multicentre retrospective study analysed youth prescribed a GLP-1RA for the management of T2D at two academic paediatric diabetes centres prior to June 2022. Change in HbA1c and insulin use from baseline to first (median 91 days) and second (median 190 days) follow-up were evaluated for those taking a GLP-1RA. Multivariable linear mixed effects models adjusting for baseline sex, age, race/ethnicity, insurance, insulin regimen, metformin regimen, GLP-1RA dosing frequency and the body mass index Z-score (BMI-Z) examined the change in HbA1c for participants for up to 6 months after baseline. RESULTS: A total of 136 patients with T2D (median age 16.1 [interquartile range 13.9-18.0] years, 54% female, 56% non-Hispanic Black, 24% Hispanic, 77% with public insurance) were prescribed GLP-1RAs and taking them at first or second follow-up. Median HbA1c decreased from 7.9% to 7.6% (P < .001) at a median follow-up of 91 days (n = 109) and, among those with HbA1c available at baseline and second follow-up (n = 83), from 8.4% to 7.4%. The proportion of patients prescribed insulin decreased from baseline to the first follow-up visit (basal 69% to 60% [P = .008], prandial 46% to 38% [P = .03]). In multivariable analysis, there was a mean decrease in HbA1c by 0.09 percentage points per month (P = .005, 95% confidence interval -0.15, -0.03). CONCLUSIONS: Real-world use of GLP-1RAs in youth with T2D is associated with decreased HbA1c levels, despite challenges with access and adherence. GLP-1RA treatment may reduce insulin doses for youth with T2D.

Delayed prandial insulin boluses are an important determinant of blood glucose control and relate to fear of hypoglycemia in people with type 1 diabetes on advanced technologies.

AIMS: Automated insulin delivery systems improve blood glucose control in patients with type 1 diabetes (T1D). However, optimizing their performance requires patient's proper compliance to meal insulin bolus administration. We explored real-life prevalence of delayed prandial boluses (DBs) in adults with T1D on advanced technologies, and their association with glycemic control and fear of hypoglycemia (FH). METHODS: In the last two-week web-based reports of 152 adults with T1D on Hybrid Closed Loop Systems (HCLS) or Sensor Augmented Pump (SAP), DBs were identified when a steep increase in blood glucose occurred at CGM before the prandial bolus, and CGM metrics were evaluated. All participants completed an online questionnaire on FH. RESULTS: Mean DBs over two weeks were 10.2 ± 4.7 (M ± SD, range 1-23) and more frequent in women than men (11.0 ± 4.6 vs. 9.4 ± 4.7, p = 0.036). Participants with more DBs (>12) showed significantly lower Time-In-Range (62.4 ± 13.8 vs. 76.6 ± 9.0 %) than those with less DBs (<7.7), along with higher Time-Above-Range, GMI, and Coefficient-of-Variation (ANOVA, p < 0.001 for all). Participants with higher FH score showed more DBs (11.6 ± 5.0) than those in lower tertiles (9.57 ± 4.59 and 9.47 ± 4.45, ANOVA p = 0.045). CONCLUSIONS: In patients on advanced technologies, delayed boluses are extremely common, and associate with significantly worse glycemic control. Utmost attention is needed to bolus timing, mainly tackling fear of hypoglycemia.

Beneficial effects of automated insulin delivery over one-year follow-up in real life for youths and adults with type 1 diabetes irrespective of patient characteristics.

AIM: To investigate glycaemic outcomes in youths and adults with type 1 diabetes with either MiniMed™ 780G or Tandem t:slim X2™ control-IQ automated insulin delivery (AID) systems and to evaluate clinical factors that migrate, mitigate the achievement of therapeutic goals. MATERIALS AND METHODS: This retrospective, real-world, observational study was conducted in a specialized university type 1 diabetes centre with patients observed for 3-12 months post-initiation of an AID system. Primary outcomes were the percentage time in the target glucose range [TIR70-180 mg/dl (3.9-10 mmol/L)] as measured by continuous glucose monitoring, mean glucose management indicator (GMI) and glycated haemoglobin (HbA1c) levels. RESULTS: Our study cohort consisted of 48 adolescents and 183 adults (55% females) aged 10-77 years. The mean (95% confidence interval) TIR70-180 mg/dl after 30 days was higher than baseline and by 14% points after 360 days with 71.33% (69.4-73.2) (n = 123, p < .001). HbA1c levels decreased by 0.7% and GMI by 0.6% after 360 days. The proportion of time spent <70 mg/dl (3.9 mmol/L) was not significantly different from baseline. During follow-up, 780G users had better continuous glucose monitoring results than control-IQ users but similar HbA1c levels, and an increased risk of weight gain. Age at onset influenced TIR70-180 mg/dl in univariate analysis but there was no significant relationship after adjusting on explanatory variables. Baseline body mass index did not influence the performance of AID systems. CONCLUSIONS: This analysis showed the beneficial effects of two AID systems for people with type 1 diabetes across a broad spectrum of participant characteristics. Only half of the participants achieved international recommendations for glucose control with TIR70-180 mg/dl >70%, HbA1c levels or GMI <7%, which outlines the need to maintain strong educational and individual strategies.

Treatment responses to basal insulin glargine 300 U/ml and glargine 100 U/ml in newly defined subphenotypes of type 2 diabetes: A post hoc analysis of the EDITION 3 randomized clinical trial.

INTRODUCTION: To compare responses to basal insulin glargine 300 U/ml (IGlar-300) and 100 U/ml (IGlar-100) in newly defined subphenotypes of type 2 diabetes. METHODS: Insulin-naive participants (n = 858) from the EDITION 3 trial were assigned to subphenotypes 'Mild Age-Related Diabetes (MARD)', 'Mild Obesity Diabetes (MOD)', 'Severe Insulin Resistant Diabetes (SIRD)' and 'Severe Insulin Deficient Diabetes (SIDD)'. Key variables were analysed at baseline and 26 weeks. RESULTS: Participants were comprised of MOD 56.1% (n = 481), SIDD 22.1% (n = 190), MARD 18.2% (n = 156) and SIRD 3.0% (n = 26). After 26 weeks a similar decrease in glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) of 16-19 mmol/mol and 1.4-1.7 mmol/L, respectively, occurred in MARD and MOD with both insulins. SIDD had the most elevated HbA1c and FPG (80-83 mmol/mol/11.1-11.4 mmol/L) and reduction in both HbA1c and FPG was greater with IGlar-100 than with IGlar-300 (-18 vs. -15 mmol/mol and -1.6 vs. -1.3 mmol/L, respectively; each p = .03). In SIDD, despite receiving the highest basal insulin doses, HbA1c decline (57-60 mmol/mol/7.3-7.6%) was suboptimal at week 26. In MOD and SIDD lower incidences with IGlar-300 were found for level 1 nocturnal hypoglycaemia [odds ratio (OR) 0.59, 95% confidence intervals (CI) 0.36-0.97; OR 0.49, 95% CI 0.24-0.99]. In addition, fewer level 2 hypoglycaemia episodes occurred at any time with IGlar-300 in SIDD (OR 0.31, 95% CI 0.13-0.77). CONCLUSION: Both insulins produce comparable outcomes in type 2 diabetes subphenotypes, but in SIDD, add-on treatment to basal insulin is required to achieve glycaemic targets.

Machine learning-based prediction of medication refill adherence among first-time insulin users with type 2 diabetes.

AIMS: The prevalence of Type 2 Diabetes Mellitus (T2DM) is projected to be 7 % in 2030. Despite its need for long-term diabetes care, the adherence rate of injectable medications such as insulin is around 60 %, lower than the acceptable threshold of 80 %. This study aims to create classification models to predict insulin adherence among adult T2DM naïve insulin users. METHODS: Clinical data were extracted from Taipei Medical University Clinical Research Database (TMUCRD) from January 1st, 2004 to December 30th, 2020. A patient was regarded as adherent if his/her medication possession ratio (MPR) was at least 80 %. Seven domains of predictors were created, including demographics, baseline medications, baseline comorbidities, baseline laboratory data, healthcare resource utilization, index insulins, and the concomitant non-insulin T2DM medications. We built two Xgboost models for internal and external testing respectively. RESULTS: Using a cohort of 4134 patients from Taiwan, our model achieved the Area Under the curve of the Receiver Operating Characteristic (AUROC) of the internal test was 0.782 and the AUROC of the external test was 0.771. the SHAP (SHapley Additive exPlanations) value showed that the number of prescribed medications, the number of outpatient visits, and laboratory data were predictive of future insulin adherence. CONCLUSIONS: This is the first study to predict adherence among adult naïve insulin users. The developed model is a potential clinical decision support tool to identify possible non-adherent patients for healthcare providers to design individualized education plans.

Closed-Loop Insulin Delivery Systems for People with Type 1 Diabetes and Chronic Very Poor Metabolic Control: It Works and Is Safe!

To evaluate the percentage of patients with type 1 diabetes (T1D) and very poor metabolic control who would agree to be treated with a hybrid closed-loop (HCL) insulin delivery system, and to assess metabolic improvement and safety. In a single center, we identified all patients aged >18 years with hemoglobin A1c (HbA1c) >11% (97 mmol/mol) before HCL treatment. We collected metabolic control and safety data up to 1 year post-HCL in those who accepted HCL after it was proposed to them. We identified 65 patients eligible for the study, 32 (50%) already used, or accepted to start using HCL. Patients were aged 18-49 years; mean(±standard deviation) baseline HbA1c was 12.5(±1.8)% (113 ± 20 mmol/mol). After 1 year, 25 patients (78%) were still using HCL and their mean HbA1c decreased to 9.4(±1.9)% (79 mmol/mol) (P < 0.001). The rate of acute metabolic events was similar during the year of follow-up to the rate in the 3 years before HCL initiation. HCL systems should be considered in patients with T1D and very poor metabolic control. ClinicalTrials registration no. NCT05282264.

Randomized Trial of the Insulin-Only iLet Bionic Pancreas for the Treatment of Cystic Fibrosis- Related Diabetes.

OBJECTIVE: Cystic fibrosis-related diabetes (CFRD) affects up to 50% of adults with cystic fibrosis and adds significant morbidity and treatment burden. We evaluated the safety and efficacy of automated insulin delivery with the iLet bionic pancreas (BP) in adults with CFRD in a single-center, open-label, random-order, crossover trial. RESEARCH DESIGN AND METHODS: Twenty participants with CFRD were assigned in random order to 14 days each on the BP or their usual care (UC). No restrictions were placed on diet or activity. The primary outcome was the percent time sensor-measured glucose was in target range 70-180 mg/dL (time in range [TIR]) on days 3-14 of each arm, and key secondary outcomes included mean continuous glucose monitoring (CGM) glucose and the percent time sensor-measured glucose was in hypoglycemic range <54 mg/dL. RESULTS: TIR was significantly higher in the BP arm than the UC arm (75 ± 11% vs. 62 ± 22%, P = 0.001). Mean CGM glucose was lower in the BP arm than in the UC arm (150 ± 19 vs. 171 ± 45 mg/dL, P = 0.007). There was no significant difference in percent time with sensor-measured glucose <54 mg/dL (0.27% vs. 0.36%, P = 1.0), although self-reported symptomatic hypoglycemia episodes were higher during the BP arm than the UC arm (0.7 vs. 0.4 median episodes per day, P = 0.01). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either arm. CONCLUSIONS: Adults with CFRD had improved glucose control without an increase in CGM-measured hypoglycemia with the BP compared with their UC, suggesting that this may be an important therapeutic option for this patient population.

Shining the Spotlight on Multiple Daily Insulin Therapy: Real-World Evidence of the InPen Smart Insulin Pen.

Objective: Connected insulin pens are creating opportunities for the millions of individuals with diabetes using multiple daily injections (MDI) therapy across the globe. Continuous glucose monitoring (CGM) data from connected insulin pens are revealing gaps and opportunities to significantly improve care for this population. In this article, we report real-world findings of the InPen™ smart insulin pen paired with CGM (InPen system), used by persons with type 1 diabetes (T1D) and type 2 diabetes (T2D). Methods: A retrospective cohort analysis was conducted with the real-world data collected from the InPen system of individuals (N = 3793 with T1D, N = 552 with T2D, and N = 808 unidentified) who used the system from January 01, 2020, to December 31, 2021. Diabetes management (e.g., missed and mistimed insulin dosing, mismatched food intake, and correction dose delivery) and glycemic outcomes were assessed. Results: In the overall and T1D populations, a dosing frequency of ≥3 doses per day and a missed dose frequency of <20% was associated with improved glycemia. In adults with T2D, missing <20% of doses was the significant factor determining improved glycemia. Conclusion: This analysis, integrating data from a smart insulin pen and CGM, provides insights into the impact of dosing behavior on glycemic outcomes and informs counseling strategies for the diabetes care team, through technologically advanced insulin management for those using MDI therapy.