Hybrid Closed-Loop Insulin Delivery System Research Articles

Efficacy of the hybrid closedloop insulin delivery system in children and adolescents with type 1 diabetes: a meta-analysis with trial sequential analysis.

The aim of this study was to assess the efficacy and safety of hybrid closed-loop (HCL) systems for insulin delivery in children and adolescents with type 1 diabetes (T1D). We searched Embase, PubMed, and Cochrane Library for randomized controlled trials (RCTs) published until March 2023 comparing the HCL therapy with control therapies for children and adolescents with T1D. We computed weighted mean differences (WMDs) for continuous outcomes and risk ratios (RRs) with 95% confidence intervals (CIs) for binary endpoints. Four RCTs and 501 patients were included, of whom 323 were randomized to HCL therapy. Compared with control therapies, HCL significantly improved the period during which glucose level was 70-180 mg/dL (WMD 10.89%, 95% CI 8.22-13.56%) and the number of participants with glycated hemoglobin (HbA1c) level < 7% (RR 2.61, 95% CI 1.29-5.28). Also, HCL significantly reduced the time during which glucoselevel was > 180 mg/dL (WMD-10.46%, 95% CI-13.99 to-6.93%) and the mean levels of glucose (WMD-16.67 mg/dL, 95% CI-22.25 to-11.09 mg/dL) and HbA1c (WMD-0.50%, 95% CI-0.68 to-0.31). There were no significant differences between therapies regarding time during which glucose level was < 70 mg/dL or <54 mg/dL or number of episodes of ketoacidosis, hyperglycemia, and hypoglycemia. In this meta-analysis, HCL compared with control therapies was associated with improved time in range and HbA1c control in children and adolescents with T1D and a similar profile of side effects. These findings support the efficacy of HCL in the treatment of T1D in this population.

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

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. To assess the effects of hybrid closed loop system on glycemic control and quality of life in adults with T1D. 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. 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. 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.

Hybrid closed-loop insulin delivery system and postprandial glycemia

Hybrid closed-loop insulin delivery system and postprandial glycemia

Safety and performance of a hybrid closed-loop insulin delivery system with carbohydrate suggestion in adults with type 1 diabetes prone to hypoglycemia

AimsTo evaluate the safety and performance of a hybrid closed-loop (HCL) system with automatic carbohydrate suggestion in adults with type 1 diabetes (T1D) prone to hypoglycemia. MethodsA 32-hour in-hospital pilot study, including a night period, 4 meals and 2 vigorous unannounced 45-minute aerobic sessions, was conducted in 11 adults with T1D prone to hypoglycemia. The primary outcome was the percentage of time in range 70–180 mg/dL (TIR). Main secondary outcomes were time below range < 70 mg/dL (TBR < 70) and < 54 (TBR < 54). Data are presented as median (10th-90th percentile ranges). ResultsThe participants, 6 (54.5%) men, were 24 (22–48) years old, and had 22 (9–32) years of T1D duration. All of them regularly used an insulin pump and a continuous glucose monitoring system. The median TIR was 78.7% (75.6–91.2): 92.7% (68.2–100.0) during exercise and recovery period, 79.3% (34.9–100.0) during postprandial period, and 95.4% (66.4–100.0) during overnight period. The TBR < 70 and TBR < 54 were 0.0% (0.0–6.6) and 0.0% (0.0–1.2), respectively. A total of 4 (3–9) 15-g carbohydrate suggestions were administered per person. No severe acute complications occurred during the study. ConclusionsThe HCL system with automatic carbohydrate suggestion performed well and was safe in this population during challenging conditions in a hospital setting.

COMPARATIVE EFFECTIVENESS AND SAFETY OF METHODS OF INSULIN DELIVERY AND GLUCOSE MONITORING FOR DIABETES MELLITUS: A SYSTEMATIC REVIEW

Introduction: Achieving glycemic control remains difficult for patients with type 1 diabetes. We compared the efficacy of day-and-night hybrid closed-loop insulin delivery to sensor-augmented pump therapy in individuals 6 years and older with suboptimally controlled type 1 diabetes.&#x0D; The aim: This article compared effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus.&#x0D; Methods: By comparing itself to the standards set by the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) 2020, this study was able to show that it met all of the requirements. So, the experts were able to make sure that the study was as up-to-date as it was possible to be. For this search approach, publications that came out between 2013 and 2023 were taken into account. Several different online reference sources, like Pubmed and SagePub, were used to do this. It was decided not to take into account review pieces, works that had already been published, or works that were only half done.&#x0D; Result: In the PubMed database, the results of our search brought up 166 articles, whereas the results of our search on SagePub brought up 143 articles. The results of the search conducted for the last year of 2013 yielded a total 116 articles for PubMed and 89 articles for SagePub. In the end, we compiled a total of 23 papers, 15 of which came from PubMed and eight of which came from SagePub. We included six research that met the criteria.&#x0D; Conclusion: The use of a hybrid closed-loop insulin delivery system in free-living conditions for a period of twelve weeks led to clinically relevant improvements in glycaemic control while simultaneously reducing the risk of hypoglycemia in suboptimally controlled type 1 diabetes in adults, adolescents, and children aged six years and older.

A Pilot randomized trial to examine effects of a hybrid closed-loop insulin delivery system on neurodevelopmental and cognitive outcomes in adolescents with type 1 diabetes

Type 1 diabetes (T1D) is associated with lower scores on tests of cognitive and neuropsychological function and alterations in brain structure and function in children. This proof-of-concept pilot study (ClinicalTrials.gov Identifier NCT03428932) examined whether MRI-derived indices of brain development and function and standardized IQ scores in adolescents with T1D could be improved with better diabetes control using a hybrid closed-loop insulin delivery system. Eligibility criteria for participation in the study included age between 14 and 17 years and a diagnosis of T1D before 8 years of age. Randomization to either a hybrid closed-loop or standard diabetes care group was performed after pre-qualification, consent, enrollment, and collection of medical background information. Of 46 participants assessed for eligibility, 44 met criteria and were randomized. Two randomized participants failed to complete baseline assessments and were excluded from final analyses. Participant data were collected across five academic medical centers in the United States. Research staff scoring the cognitive assessments as well as those processing imaging data were blinded to group status though participants and their families were not. Forty-two adolescents, 21 per group, underwent cognitive assessment and multi-modal brain imaging before and after the six month study duration. HbA1c and sensor glucose downloads were obtained quarterly. Primary outcomes included metrics of gray matter (total and regional volumes, cortical surface area and thickness), white matter volume, and fractional anisotropy. Estimated power to detect the predicted treatment effect was 0.83 with two-tailed, α = 0.05. Adolescents in the hybrid closed-loop group showed significantly greater improvement in several primary outcomes indicative of neurotypical development during adolescence compared to the standard care group including cortical surface area, regional gray volumes, and fractional anisotropy. The two groups were not significantly different on total gray and white matter volumes or cortical thickness. The hybrid closed loop group also showed higher Perceptual Reasoning Index IQ scores and functional brain activity more indicative of neurotypical development relative to the standard care group (both secondary outcomes). No adverse effects associated with study participation were observed. These results suggest that alterations to the developing brain in T1D might be preventable or reversible with rigorous glucose control. Long term research in this area is needed.

Closed-Loop Insulin Pump Therapy in Young Type 1 Diabetic Children

Source: Ware J, Allen JM, Boughton CK, et al. Randomized trial of closed-loop control in very young children with type 1 diabetes. N Engl J Med. 2022;386:209-219; doi: 10.1056/NEJMoa2111673Investigators from multiple institutions conducted a crossover randomized trial to compare the effectiveness and safety of a closed-loop system (ie, artificial pancreas) to sensor-augmented insulin pump therapy in young children with type 1 diabetes. Participants were children 1-7 years old with a diagnosis of type 1 diabetes for at least 6 months, recruited from diabetes centers in 4 European countries. The closed-loop system consisted of a continuous glucose sensor and insulin pump connected to a smartphone app. The app included an algorithm that automatically adjusted insulin delivery based on real-time sensor glucose readings. With the sensor-augmented pump, insulin therapy was stopped if an algorithm predicted that sensor glucose levels were likely to drop below a specified threshold. Study children were randomized to receive 16 weeks of treatment with the closed loop system, followed by 16 weeks using the augmented-sensor pump, or vice versa. The primary outcome was percentage of time spent in the target glucose range (70 to 170 mg/dL) during each treatment period. Secondary outcomes included percentage of time spent in a hyperglycemic range (>180 mg/dL) and hypoglycemic range (<70 mg/dL) and mean glucose levels. These outcomes were based on readings from the glucose sensors. Glycated hemoglobin levels were measured at baseline and at the end of each treatment period. Differences in outcomes between the closed-loop and sensor-augmented pump treatment period were assessed with repeated-measures linear regression models. Data on adverse events also were collected.Data were analyzed on 74 children with a mean age of 5.6 ±1.6 years. The mean glycated hemoglobin level at baseline was 7.3 ±0.7%. The mean time spent in the target glucose range were 71.6 ±5.9% during the closed-loop period and 62.9 ±9.0% in the sensor-augmented pump period (adjusted difference, 8.7 percentage points; 95% CI, 7.4, 9.9; P <0.001). The median time spent at glucose level >180 mg/dL was significantly less during the closed-loop period than during the control period (22.9% vs 31.7%; adjusted difference, -8.5 percentage points; 95% CI, -.9.9, -7.1; P <0.001); mean sensor glucose levels (145 ±11.8 mg/dL and 158.1 ±18.5 mg/dL, respectively; P <0.001) and mean glycated hemoglobin levels (6.6 ±0.6% and 7.0 ±0.7%) were significantly lower during the closed-loop period than during treatment with the segmented-sensor pump. There was no difference between treatment periods for percentage of time with glucose <70 mg/dL (P = 0.74). One participant had a serious adverse event (severe hypoglycemia) during their closed-loop treatment period.The authors conclude that a closed-loop system improved glycemic control in young children with type 1 diabetes.Dr Fechner has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.Type 1 diabetes is very difficult to manage in the young child. The therapeutic window for insulin is very narrow, with too much insulin resulting in hypoglycemia and too little insulin resulting in hyperglycemia. The last 5 years have seen tremendous advances in the technology available to children with type 1 diabetes. A 2019 study comparing the insulin pump to multiple daily injections showed that the insulin pump was superior to multiple daily injections. (See AAP Grand Rounds. 2019;42[1]:4.) Continuous glucose monitoring has decreased parental anxiety regarding risk of hypoglycemia and diabetic ketoacidosis;1 however, parents still are responsible for making insulin dose adjustments, and glycemic control overall is not improved.2 The results of a 2020 study of 6- to 13-year-olds with type 1 diabetes demonstrated that glucose levels were in the target range for a longer period of time in those randomized to a closed-loop system than those using a sensor-augmented pump. (See AAP Grand Rounds. 2020;44[6]:69.)3 The current researchers compared a hybrid closed-loop insulin delivery system to sensor-augmented pump therapy in younger children with type I diabetes.The strengths of the current study are the randomized, crossover design using the same algorithm with the closed-loop functionality either abled or disabled; each therapy was 16 weeks, which allowed a meaningful glycated hemoglobin to be obtained. There were no restrictions on previous episodes of hypoglycemia and diabetic ketoacidosis, and the study included a very young children with diabetes, who are more vulnerable to hypo- and hyperglycemia. Weaknesses of this study include underrepresentation of ethnic minorities and a patient population not representative of the typical type 1 diabetes population, as the average glycated hemoglobin level was 7.3% at baseline.4 Decreased patient compliance outside of the confines of a study may be reflected in poorer glucose control regardless of the insulin delivery system used.Hybrid closed-loop insulin therapy in young children with type 1 diabetes has the potential to significantly improve long-term outcomes through improved glycemic control.

Cost-Effectiveness Analysis of an Advanced Hybrid Closed-Loop Insulin Delivery System in People with Type 1 Diabetes in Greece.

AbstractIntroduction: Usage of automated insulin delivery systems is increasing for the treatment of people with type 1 diabetes (T1D). This study compared long-term cost-effectiveness of the Advanced Hybrid Closed Loop MiniMed 780G (AHCL) system versus sensor augmented pump (SAP) system with predictive low glucose management (PLGM) or multiple daily injections (MDI) plus intermittently scanned continuous glucose monitoring (isCGM) in people with T1D in Greece. Methods: Analyses were performed using the IQVIA CORE Diabetes Model, with clinical input data sourced from various studies. In the AHCL versus SAP plus PLGM analysis, patients were assumed to have 7.5% baseline glycated hemoglobin (HbA1c), when comparing AHCL with MDI plus isCGM baseline HbA1c was assumed to be 7.8%. HbA1c was reduced to 7.0% following AHCL treatment initiation but remained at baseline levels in the comparator arms. Analyses were performed from a societal perspective over a lifetime time horizon. Future costs and clinical outcomes were discounted at 1.5% per annum. Results: AHCL was associated with increased quality-adjusted life expectancy of 0.284 quality-adjusted life years (QALYs) and EUR 10,173 lower mean total lifetime costs with SAP plus PLGM. Compared with MDI plus isCGM, AHCL was associated with increased quality-adjusted life expectancy of 2.708 QALYs, EUR 76,396 higher mean total lifetime costs, and an incremental cost-effectiveness ratio of EUR 29,869 per QALY. Extensive sensitivity analysis confirmed the robustness of results. Conclusions: Over patient lifetime, the MiniMed 780G system is likely to be cost saving compared with the SAP plus PLGM system and cost-effective compared with MDI plus isCGM in people with T1D in Greece.

Opportunities and challenges in closed-loop systems in type 1 diabetes

Commercial automated insulin delivery therapy can improve glucose outcomes by increasing glucose time-in-range (3·9–10·0 mmol/L; 70–180 mg/dL) and reducing hypoglycaemia (<3·9 mmol/L; <70 mg/dL) in people with type 1 diabetes. Commercial closed-loop systems have shown modest improvement in percentage time-in-range, with an increase of 5 percentage points for MiniMed 670G 1 Bergenstal RM Garg S Weinzimer SA et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA. 2016; 316: 1407-1408 Crossref PubMed Scopus (377) Google Scholar and of 10 percentage points for Control-IQ 2 Brown SA Kovatchev BP Raghinaru D et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Engl J Med. 2019; 381: 1707-1717 Crossref PubMed Scopus (266) Google Scholar compared with open-loop therapy. New developments with closed-loop systems are likely to enable further improvements in glucose outcomes while reducing user burden for individuals able to access closed-loop systems. These developments are focused on addressing deficiencies with current closed-loop systems by, for example, reducing or eliminating the requirement of prandial insulin dosing, overcoming the slow kinetics of subcutaneous insulin compared with endogenous insulin production, and improving the handling of insulin before, during, and after exercise. These advances will ideally lead to improved performance and reduced patient burden, and enable more widespread usage.

Real-World, Patient-Reported and Clinic Data from Individuals with Type 1 Diabetes Using the MiniMed 670G Hybrid Closed-Loop System.

Background: The purpose of this study was to collect 1 year of real-world data from individuals with type 1 diabetes (T1D) initiating the Medtronic 670G hybrid closed-loop insulin delivery system as part of usual care. We sought to expand current knowledge to understand how use of the system impacts patient-reported outcomes, in addition to clinical outcomes, for children and adults with T1D. Methods: Questionnaires were completed by the participant (and/or parent) before initiation of the 670G system (baseline) and at 6 weeks, 6 months, and 12 months from enrollment. Clinical data were obtained at routine clinical visits. Results: Of 132 participants who initiated Auto Mode, 80 completed the 12-month questionnaires while persisting with the system. Nearly all reported receiving adequate training on the 670G. Participant and parent-reported fear of hypoglycemia decreased by 6 and 11 points, respectively, from baseline to 12 months. More than half reported issues with sleep interruption at night due to alarms and 40% did not like frequent exits from Auto Mode. For the subset who had complete continuous glucose monitor data (n = 27), mean percent time in target range (70-180 mg/dL) was 66% at baseline, and 74% and 68% at 6 and 12 months, respectively. Conclusions: With this study, we have captured real-time feedback from patients with T1D who initiated the 670G system and continued to use it over 12 months regarding their experience with the system. This has helped to illuminate both benefits and burdens associated with the first commercially available hybrid closed-loop system.

Hybrid Closed-Loop Insulin Delivery Systems for People With Type 1 Diabetes

&#x0D; Blood glucose monitoring and insulin delivery are essential parts of the management of type 1 diabetes. Hybrid closed-loop insulin delivery (HCL) systems are a treatment option for people with type 1 diabetes and consist of an insulin pump, a continuous glucose monitor (CGM), and a computer program (algorithm) that allows the devices to communicate with each other and calculates insulin needs.&#x0D; CADTH conducted a Health Technology Assessment (HTA) of the use of HCL systems compared to other insulin delivery methods in people with type 1 diabetes to inform decisions regarding whether HCL systems have a place in the management of type 1 diabetes.&#x0D; HCL therapy generally improved the amount of time a person spent in target blood glucose ranges. Additionally, people who used HCL systems had improved average blood glucose levels (glycated hemoglobin [A1C]) over the preceding 2 or 3 months. However, the effectiveness or safety of HCL systems based on age, sex, race, glucose management, or other clinical features (e.g., those who are pregnant or planning pregnancy, or who have hypoglycemia unawareness or a history of severe hypoglycemia) is unknown. HCL systems were generally as safe as other insulin delivery methods. Additional studies with longer follow-up periods and more participants are needed to confirm the clinical effectiveness and safety of HCL systems.&#x0D; From a pan-Canadian, publicly funded health care system perspective, the cost of covering HCL systems for individuals with type 1 diabetes who are eligible for insulin pumps in their jurisdictions was estimated to be an additional $822,635,045 over 3 years compared with diabetes supplies that are currently covered. If HCL systems are covered for all individuals with type 1 diabetes, regardless of their current insulin-pump eligibility, the budget impact will be higher.&#x0D; HCL systems can help provide distance from demanding self-management and monitoring tasks for people living with type 1 diabetes; however, in order to do this, people using these systems must navigate complex relationships built on trust and collaboration. Given that type 1 diabetes self-management to date has required considerable attention to blood glucose numbers and technical tasks, developing these relationships of trust and collaboration will require a shift in understanding what it means to care for someone who has — or to self-manage — type 1 diabetes.&#x0D; It is not possible to conclude whether HCL systems will improve overall population health over the longer-term because the data for this are not available. It is also unclear which people with type 1 diabetes would benefit most from HCL systems. Eligibility criteria for the existing public insulin-pump program may be useful in making coverage decisions; trial periods may be considered to ensure HCL systems are working well for new users.&#x0D; Education and support are needed for people living with type 1 diabetes when they start to use HCL systems. Clinicians noted the need for interactions between diabetes educators and HCL system pump users. User-friendly devices and understandable reports are key to effective use.&#x0D; Eligibility for access through any publicly funded program for HCL systems should be based on evidence. The criteria for coverage should be consistent with broader public health goals and should not contribute to existing inequities in diabetes management.&#x0D;

976-P: Evaluation of Hybrid Closed-Loop Insulin Delivery System for Patients with Type 1 Diabetes in Real-World Clinical Practice: A One-Year Qualitative Observational Study

The MiniMed™ 670G (670G) is the first FDA approved hybrid closed-loop insulin delivery system for patients with type 1 diabetes (T1D). In Auto Mode, the integrated continuous glucose monitor (CGM) captures glucose values every five minutes and, via a built-in algorithm, the 670G system automatically adjusts basal insulin delivery targeting a glucose value of 120 mg/dL. Impact of the use of 670G system on patient reported outcomes in people with T1D are limited. Data over one year of use in real world-clinical practice were collected. We evaluated 53 patients with T1D (mean age 46.8±11.8 years, 62% females, body weight 82.5±17.6 kg, BMI 28.7±5.5, HbA1c 7.6±0.8%) who started 670G at the Joslin Clinic between December 2017 and December 2019. Data were collected at baseline and after 12 months. We assessed SROs by administering surveys: 36 Item Short-Form Health Survey (SF 36), Pittsburgh Sleep Quality Index (PSQI), and hypoglycemia fear survey/worry scale (HFS_W). We also measured HbA1c, % time-in-range at baseline and 12 months, and % time in auto mode (TiAM) for the two weeks preceding the final study visit. At 12 months, A1C decreased by 0.3±0.1% from baseline (p&amp;lt;0.01) and % time-in-range increased by 7.9±3.1% from baseline (p=0.015) with no correlation between either of them and %TiAM (p=0.3, p=0.2 respectively). Physical functioning increased by 47.5% from baseline (p&amp;lt;0.001), and HFS_W improved significantly by -16.0% from baseline (p=0.017). At 12 months, average %TiAM was 60.4±33.7% and was not associated with clinical outcomes or SROs. We conclude that use of 670G for a year in real-world clinical practice was associated with significant improvement in A1C, % time-in-range, physical functioning and hypoglycemia fear. Neither of these improvements at 12 months was related to %TiAM. Disclosure A.H. Eldib: None. S. Tomah: Stock/Shareholder; Self; Amarin Corporation. S.E. Dhaver: None. H. Gardner: None. M. Tasabehji: None. M. Albadri: None. A. Atakov-Castillo: None. E. Toschi: None. O. Hamdy: Consultant; Self; Abbott, AstraZeneca, Merck &amp; Co., Inc., Sanofi-Aventis. Research Support; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Healthimation, LLC.

Clinical Experience with the Hybrid Closed-Loop Insulin Delivery System (MinimedTM 670G) compared to Sensor Augmented Therapy (MiniMedTM 640G) and standard care

Clinical Experience with the Hybrid Closed-Loop Insulin Delivery System (MinimedTM 670G) compared to Sensor Augmented Therapy (MiniMedTM 640G) and standard care

121-LB: Early Independent View of Quality of Life in Patients with Type 1 Diabetes Using Hybrid Closed-Loop Insulin Delivery System in Real-World Clinical Practice

The MiniMed™ 670G (670 HCL) is the first FDA-approved hybrid closed-loop insulin delivery system device for patients with type 1 diabetes (T1D). This study aimed at evaluating clinical and patient-reported outcomes (PROs) in patients with T1D utilizing this technology. We evaluated 54 patients with T1D using the 670 HCL in real-world clinical practice (mean age 47.9±13.2 years, 57% females, BMI 28.8±5.9 kg/m2). Data were collected at baseline and after 3 months. Measures of PROs included: Pittsburgh Sleep Quality Index (PSQI), Hypoglycemia Fear Survey Worry (HFS_W) scale, and 36-Item Short-Form Health Survey (SF-36). We also measured changes in A1C after 3 months and % of time in auto-mode (% TIAM) over the two weeks preceding the 3-month visit. Regression analyses were done between these 2 parameters and PROs. Other glycemic and quality-of-life parameters were collected at 3 months and at one year but are not included in this early report. At 3 months, A1C decreased by 0.4±0.12% from baseline (p=0.0027). Average % TIAM was 63.9±33.1%. Among all surveyed PROs, only fear of hypoglycemia and social functioning improved compared to baseline (p&amp;lt;0.05 for both). There was no association between changes in PROs and reduction in A1C or % TIAM. In conclusion, patients with T1D using the MiniMed™ 670G hybrid closed-loop system in real-world clinical practice are able to improve their A1C, fear of hypoglycemia, and social functioning but not other PROs included in the SF-36 after 3 months of use. The limited improvement in some of the PROs is not associated with the reduction in A1C or % TIAM. Disclosure A.H. Eldib: None. E. Toschi: Advisory Panel; Self; Lexicon Pharmaceuticals, Inc. N. Mahmoud: None. M. Tasabehji: None. S. Ashrafzadeh: None. S. Tomah: Stock/Shareholder; Self; Amarin Corporation. S.E. Dhaver: None. A. Atakov-Castillo: None. A.E. Abdul-Ghani: None. K. Farkouh: None. R. Trevino: None. O. Hamdy: Advisory Panel; Self; AstraZeneca, Sanofi-Aventis. Consultant; Self; Abbott, Merck &amp; Co., Inc. Research Support; Self; National Dairy Council. Stock/Shareholder; Self; Healthimation, LLC.

282-OR: Impact of a Hybrid Closed-Loop Insulin Delivery System on Hypoglycemia Awareness in Individuals with Type 1 Diabetes

Background: Individuals with impaired awareness of hypoglycemia (IAH) are at risk of severe hypoglycemia. Although it is known that elimination of hypoglycemia can restore hypoglycemia awareness in this high-risk group, this has been challenging in real life. Technological advancements like closed loop system provide an opportunity to minimize hypoglycemia. Hence, the aim of this study was to evaluate whether a hybrid closed loop insulin delivery system can improve hypoglycemia awareness in individuals with IAH. Methods: Participants with type 1 diabetes and IAH (Gold Score ≥4) were randomized to either a hybrid closed loop system (Medtronic 670G) (intervention) or standard insulin pump therapy (control) for 8 weeks. Gold scores and hyperinsulinemic hypoglycemic clamp studies were undertaken at baseline and at the end of the study with evaluation of the hormonal and symptomatic responses to hypoglycemia. Results: A total of 17 participants completed the study (mean (SD) age 35.8 years (11.2), diabetes duration 24.2 years (11.3), HbA1c 7.8% (1.2)). 8 participants were randomized to control and 9 participants to intervention. The baseline (Median, IQR) Gold score was 6.0 (5.0; 6.0) in the overall cohort and did not differ between groups. At the study end, Gold score improved in the intervention group: control vs. intervention 6.0 (4.5; 6.0) vs. 3.5 (3.0; 4.5); p = 0.027. Symptom scores (adrenergic and neuroglycopenic) during the clamp were not different between the control and intervention groups. Conclusions: The use of a hybrid closed loop system over 8 weeks improved self-reported hypoglycemia awareness, however there was no evidence for improvement in the symptomatic responses to experimentally induced hypoglycemia. Disclosure M. Burckhardt: None. J. Dart: None. G.J. Smith: None. M.B. Abraham: None. N. Paramalingam: None. J.M. O'Dea: None. M. de Bock: None. E.A. Davis: None. T. Jones: Research Support; Self; Dexcom, Inc., Medtronic MiniMed, Inc. Speaker's Bureau; Self; Eli Lilly and Company, Roche Diabetes Care.

A Hybrid Closed-loop Insulin Delivery System for the Treatment of Type I Diabetes

A Hybrid Closed-loop Insulin Delivery System for the Treatment of Type I Diabetes

More Evidence That the “Artificial Pancreas” Is Safe and Effective

In 2016, the FDA approved the first hybrid closed-loop insulin delivery system (“artificial pancreas”) for adults and adolescents with type 1 diabetes;

The Artificial Pancreas: What School Nurses Need to Know.

The hybrid closed-loop insulin delivery system, a form of "artificial pancreas," is composed of an insulin pump, a standardized algorithm, and a continuous glucose monitor. The system streamlines insulin delivery by connecting continuous glucose monitor data with an insulin pump and an algorithm to drive basal insulin delivery. The hybrid closed-loop insulin delivery system, approved by the Food and Drug Administration in 2016 for children older than 7 years, is a major improvement in the management of type 1 diabetes. The purpose of this article is to educate school nurses about the components of the hybrid closed-loop insulin delivery system, the relevance to care, and the future direction of blood glucose management.

Real-World Data from the MiniMed™ 670G System Commercial Launch—The First 1,052 Patients Using the System for Three Months

The Medtronic MiniMed™ 670G hybrid closed-loop system with SmartGuard™ technology was released for commercial use in the U.S. in March 2017. Sensor glucose (SG) and device utilization data from the initial open-loop Manual Mode and closed-loop Auto Mode periods were analyzed for the first 1052 patients and compared to those from the MiniMed™ 670G system pivotal trial1. De-identified data voluntarily uploaded to CareLink™ Personal software, from 3/17/17 to 11/11/17, were evaluated monthly, for 3 months. Data for 12,758 patient-days in Manual Mode and 142,065 patient-days after Auto Mode start were compared to results of the MiniMed™ 670G pivotal trial (124 patients aged 14-75 years) conducted from 6/2/15 to 3/7/16. The percentage of time in Auto Mode, after initiation, was &amp;gt;85% over the 3 months for the entire commercial cohort. The SG values across glucose ranges were comparable to pivotal trial data (Table). These findings indicate that outcomes data for the first 1052 patients using the commercial MiniMed™ 670G system mirrored the pivotal trial outcomes. Further, the increased time in target range and decreased hypoglycemia and hyperglycemia were sustained over 3 months. Pivotal TrialCommercial LaunchManual ModeAuto ModeManual ModeAuto Mode Month 1Auto Mode Month 2Auto Mode Month 3Patients, N1241241052105210521052Auto Mode Use, %-87.20-88.6086.7885.96Mean SG, mg/dL150.2150.78157.02149.84150.30150.75Percentage of time in SG range, mg/dL&amp;lt;500.850.520.380.300.320.33&amp;lt;541.330.780.600.460.500.52&amp;lt;705.472.952.652.072.212.2370-18067.1372.6167.3975.0074.3674.07&amp;gt;18027.424.4529.9622.9323.4323.70&amp;gt;2506.945.587.494.504.865.14 1. Garg SK, Weinzimer SA, Tamborlane WV, et al. Glucose outcomes with the in-home use of a hybrid closed-loop insulin delivery system in adolescents and adults with type 1 diabetes. Diabetes Technol Ther. 2017;19:155-163. Disclosure P. Agrawal: None. M. Stone: None. S. Gopalakrishnan: Employee; Self; Medtronic. C. Fogel: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic.

Twelve-Week Home Use of Hybrid Closed-Loop Insulin Delivery System vs. Sensor-Assisted Pump Therapy in Adults with Type 1 Diabetes—Intermediate Results of the Multicenter Randomised Crossover Diabeloop WP7 Trial

Objective: Availability of closed-loop insulin delivery systems is expected by patients with type 1 diabetes. Our main objective was to assess whether patients using the Diabeloop artificial pancreas system could achieve a better glucose control compared to sensor-assisted pump therapy, as measured by percentage time in range 70-180 mg/dl. Methods: A multicenter clinical trial was conducted in a home setting, using an MPC-based algorithm, a hybrid monohormonal system (CellNovo® pump and Dexcom G5® sensor) and centralised remote monitoring. Adult patients with T1D for ≥ 2 years, pump therapy for ≥ 6 months, HbA1c ≤ 10%, and preserved hypoglycemia awareness were included among 12 investigation centers. Design was a crossover trial with a 2-week run-in period, followed by 2 sequences of 12 weeks each separated with washout. Results of the first 12-week arm are reported. Results: 68 patients (27 men, age 47.2±13.4 years, HbA1c 7.6±0.9%, duration of disease 27.9±13.2 years) were randomised between closed-loop (CL, n=33) and open-loop (OL, n=35) first. During the first 12-week period, time spent in the 70-180 mg/dl range was 69.5% [62.4;75.6] in CL vs. 58.7% [45.2;64.9] in OL. Time in hypoglycaemia &amp;lt;70 mg/dl was 2.1% [1.2;2.6] in CL vs. 4.1% [1.9;6.1] in OL. Conclusion: The Diabeloop closed-loop system was efficient regarding metabolic outcomes. Disclosure S. Franc: Consultant; Self; Animas Corporation, Roche Diabetes Care Health and Digital Solutions, Johnson &amp; Johnson Diabetes Institute, LLC. P.Y. Benhamou: Consultant; Self; Abbott, Sanofi, Novo Nordisk Inc.. Other Relationship; Self; Eli Lilly and Company, Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Diabeloop S.A. S. Borot: Consultant; Self; Abbott, Animas Corporation, Johnson &amp; Johnson Diabetes Institute, LLC., Medtronic, Roche Diabetes Care Health and Digital Solutions. L. Chaillous: None. B. Delemer: Other Relationship; Self; Sanofi-Aventis, Eli Lilly and Company. B. Guerci: None. H. Hanaire: Consultant; Self; Abbott, Animas Corporation, Johnson &amp; Johnson Diabetes Institute, LLC., Medtronic, Roche Diabetes Care Health and Digital Solutions. N.M. Jeandidier: Board Member; Self; Sanofi-Aventis. E. Renard: Advisory Panel; Self; Abbott. Board Member; Self; Eli Lilly and Company, Insulet Corporation, Novo Nordisk A/S, Sanofi, Roche Pharma. Consultant; Self; Air Liquide. Research Support; Self; Roche Pharma, Dexcom, Inc., TypeZero Technologies, Inc.. Y. Reznik: None. P. Schaepelynck: Consultant; Self; Roche Diabetes Care Health and Digital Solutions. Speaker's Bureau; Self; Medtronic MiniMed, Inc.. Board Member; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Sanofi-Aventis, Abbott, Eli Lilly and Company. C. Thivolet: Advisory Panel; Self; Abbott, Sanofi-Aventis, Medtronic MiniMed, Inc. G. Charpentier: Consultant; Self; Abbott, Dexcom, Inc., Medtronic.