Bionic Pancreas Research Articles

Experiences of People With Type 1 Diabetes Using the iLet Bionic Pancreas in Primary Care: A Qualitative Analysis

This qualitative substudy sought to identify and understand the experiences of primary care patients with type 1 diabetes using the iLet Bionic Pancreas (Beta Bionics, Inc.) during the first clinical trial testing the automated insulin delivery (AID) system in the primary care setting. Participants in that clinical trial completed a brief semi-structured interview after the trial’s completion during which they were asked questions related to their perceptions of and experiences with using the iLet AID system. Analysis of 16 interviews revealed five major themes, which highlighted the positive and beneficial impact of the system on psychological and behavioral aspects of diabetes management.

Adult's Lived Experience Using the Insulin-Only Bionic Pancreas.

The purpose of this study was to assess adults' perspectives after using the insulin-only Bionic Pancreas (BP) during a 13-week pivotal trial. Automated insulin delivery (AID) systems show promise in improving glycemic outcomes and reducing disease burden for those with type 1 diabetes mellitus (T1D). Understanding the lived experience of those using the BP can help to inform education and uptake of AID devices. Adults ages 19 to 75 (n = 40) participated in age-specific focus groups (19-25, 26-40, 41-64, and 65+) exploring their experiences, thoughts, and feelings about using the BP. Three authors analyzed the focus group data using a hybrid thematic approach. Qualitative analysis of focus groups revealed 14 sub-themes falling into four major themes (diabetes burden, managing glucose levels, daily routine, and user experience). Although participants' overall experience was positive, some reported struggles related to managing out-of-range glucose levels and challenges with the system responding to unique meal schedules and exercise regimens. This study captures patient perspectives regarding their experiences with a new AID system. Patient voice can inform device development and educational approaches for people with T1D. Identifying which patients may benefit the most from wearing this system may facilitate patient/clinician discussions regarding insulin delivery systems that best meet their individualized needs and expectations that may support device uptake and continued use.

948-P: Glycemic and CGM Outcomes Are Nearly Independent of the Frequency of User Engagement with the Bionic Pancreas during 13 Weeks of Use in Adults and Children with Type 1 Diabetes

948-P: Glycemic and CGM Outcomes Are Nearly Independent of the Frequency of User Engagement with the Bionic Pancreas during 13 Weeks of Use in Adults and Children with Type 1 Diabetes

957-P: Feasibility Study of Use of the iLet Bionic Pancreas in Primary Care and Telehealth

957-P: Feasibility Study of Use of the iLet Bionic Pancreas in Primary Care and Telehealth

Parent, child, and adolescent lived experience using the insulin-only iLet Bionic Pancreas.

Automated insulin delivery (AID) systems show great promise for improving glycemic outcomes and reducing disease burden for youth with type 1 diabetes (T1D). The current study examined youth and parent perspectives after using the insulin-only iLet Bionic Pancreas (BP) during the 13-week pivotal trial. Parents and youth participated in focus group interviews, with questions assessing participants' experiences in a variety of settings and were grounded in the Unified Theory of Acceptance and Use of Technology. Qualitative analysis was completed by 3 authors using a hybrid thematic analysis approach. Qualitative analysis of focus groups revealed a total of 19 sub-themes falling into 5 major themes (Diabetes Burden, Freedom and Flexibility, Daily Routine, Managing Glucose Levels, and User Experience). Participants' overall experience was positive, with decreased burden and improved freedom and flexibility. Some participants reported challenges in learning to trust the system, adjusting to the user interface, and the system learning their body. This study adds to the growing literature on patient perspectives on using AID systems and was among the first to assess caregiver and youth experiences with the BP system over an extended period (13 weeks). Patient feedback on physical experiences with the device and experiences trusting the device to manage glucose should inform future development of technologies as well as approaches to education for patients and their families.

Biomimetic Hydrogels Promote Pseudoislet Formation to Improve Glycemic Control in Diabetic Mice.

Islet or β-cell transplantation is currently considered to be the ideal treatment for diabetes, and three-dimensional (3D) bioprinting of a bionic pancreas with physiological stiffness is considered to be promising for the encapsulation and transplantation of β-cells. In this study, a 5%GelMA/2%AlgMA hybrid hydrogel with pancreatic physiological stiffness was constructed and used for β-cell encapsulation, 3D bioprinting, and in vivo transplantation to evaluate glycemic control in diabetic mice. The hybrid hydrogel had good cytocompatibility and could induce insulin-producing cells (IPCs) to form pseudoislet structures and improve insulin secretion. Furthermore, we validated the importance of betacellulin (BTC) in IPCs differentiation and confirmed that IPCs self-regulation was achieved by altering the nuclear and cytoplasmic distributions of BTC expression. In vivo transplantation of diabetic mice quickly restored blood glucose levels. In the future, 3D bioprinting of β-cells using biomimetic hydrogels will provide a promising platform for clinical islet transplantation for the treatment of diabetes.

Testing the Real-World Accuracy of the Dexcom G6 Pro CGM During the Insulin-Only Bionic Pancreas Pivotal Trial.

Continuous glucose monitors (CGMs) have transformed the way people with type 1 diabetes can self-monitor glucose levels. Past studies have evaluated the accuracy of CGMs in clinic-based studies, but few have analyzed their accuracy in real-world settings. The Insulin-Only Bionic Pancreas Trial provided the opportunity to assess real-world accuracy of the blinded Dexcom G6 Pro sensor over the first 48-60 h of wear using a blood glucose meter (BGM) as a comparator for 1073 CGM-BGM pairs across 53 participants. The mean absolute relative difference (MARD) was 11.0% over a median period of 50 h (range 47-79 h). The MARD was 13.6% in the first 12 h, 10.5% in hours 12-24, and 10.1% after the first 24 h. These results are comparable with accuracy shown previously with laboratory-based measurements and provide real-world evidence of Dexcom G6 Pro accuracy, which improved after the first 12 h and then remained stable thereafter. Clinical Trial Registry: clinicaltrials.gov; NCT04200313.

228.3: 3D bioprinting of a bionic pancreas with a vascular system - results of transplantation in large animals.

228.3: 3D bioprinting of a bionic pancreas with a vascular system - results of transplantation in large animals.

Bionic pancreas reduces HbA1c compared with standard insulin delivery

Bionic pancreas reduces HbA1c compared with standard insulin delivery

90-OR: 3D Bioprinting of a Bionic Pancreas with a Vascular System—Results of Transplantation in Large Animals

The transplantation of the pancreas is recommended in diabetes with complications. The combination of cell biology and 3D-bioprinting can create organs with vasculature which should be functional. There are issues to be solved: leakage, thrombosis, enhancement against high pressure, connecting organ to the recipient. The purpose of this study was to demonstrate 3D-bioprinting of bionic organs with use of dECM-derived biomaterials with stable flow through the organ in vitro and in large animal studies. Materials and methods: Mathematical analysis in the designed bionic pancreas was performed. The bionic pancreas was 3D bioprinted with 2 types of bioinks. The first tests were carried out in a bioreactor then organs were subjected to magnetic resonance and X-ray with contrast. Pressure endurance tests were performed. 14 pigs received 3D-bioprinted bionic pancreas transplantation. DCL-VESS-Group (n=5) received decellularized vessels as anastomosis. 9 pigs received bionic pancreas with vascular prosthesis as anastomosis - Prosthesis-Group. Pigs were observed up to 14 days. Hist-pat analysis of removed pancreas was performed. Results: The tests carried out in the bioreactor showed the stability of the bionic organ and vascular system in MRI and X-ray examination for 5 days. No leaks beyond the bionic pancreas were observed up to 400 mmHg. In all 14 cases of transplantation there was stable flow throughout the organ after release of vascular clamp. DCL-VESS-Group - In all cases vascular cloth was observed. Prosthesis-Group - In 5 cases there were no complications influencing blood flow through the organ. 4 died to postoperative complications. Stable flow within a transplanted bionic organ was observed till 2 weeks post - surgery within ultrasound examination and radiology intervention. Histopatological showed the presence of CD31 / PECAM-1 (new blood formation). Conclusion: It is feasible to 3Dbioprint and transplant bionic organ in big animal model. Disclosure M.Wszola: Board Member; Polbionica Ltd., Stock/Shareholder; Polbionica Ltd.. K.I.Roszkowicz-ostrowska: None. L.Kownacki: None. J.Wolinski: None. A.Dobrzyn: None. A.Kaminski: None. A.Berman: Board Member; Polbionica Ltd., Stock/Shareholder; Polbionica Ltd. M.Klak: Employee; Polbionica Sp. z o.o., Stock/Shareholder; Polbionica Sp. z o.o. T.Dobrzanski: Employee; Polbionica. O.Janowska: Employee; POLBIONICA Sp. z o.o. S.Domanski: Employee; Polbionica. D.Piatek: None. J.Wejman: None. D.Szkopek: None.

430-P: Glycemic Control Assessed by Continuous Glucose Monitoring among Dialysis Patients With and Without Diabetes Mellitus

Introduction: Glycemic control for dialysis patients with diabetes mellitus (DM) is challenging due to limitations of HbA1c, risk of hypoglycemia, and fewer options for glucose-lowering agents. We sought to comprehensively describe glycemic patterns among dialysis patients using continuous glucose monitoring (CGM). Methods: The Blood Sugar Sensing On Maintenance Dialysis (BLOSSOM) study is a prospective community-based cohort of people treated with dialysis, with or without DM, designed to assess the prevalence, causes, and consequences of dysglycemia. Each participant wore a Dexcom G6 CGM for 10 days. This interim analysis examined the first 153 BLOSSOM dialysis participants. Results: Dialysis participants had a mean (SD) age of 61 (14) years, 132 (86%) underwent hemodialysis, and 21 (14%) were treated with peritoneal dialysis (PD). Among 90 dialysis participants with DM, mean (SD) glucose management indicator (GMI) was 7.9% (1.2%), time in range (TIR) (70-180 mg/dL) was 50% (29%) and 27 (30%) participants achieved TIR ≥70%. Mean (SD) time high (>180 mg/dL), very high (>250 mg/dL), low (<70 mg/dL) and very low (<54 mg/dL) was 49% (29%), 21% (23%), 2% (11%) and 1% (11%), respectively. Of 63 dialysis participants without DM, mean (SD) GMI was 6.2% (0.4%), and time in normal range (70-140 mg/dL) 75% (18%). Mean (SD) time low and very low were 2% (8%) and 0% (3%), with low and very low sensor glucose values seen in 38 (60%) and 23 (37%) participants, respectively. PD patients without known DM (n=9) had a mean (SD) GMI of 6.6% (0.3%) and spent mean (SD) 54% (21%) of time in normal range. Conclusions: In this community-based sample of maintenance dialysis patients, uncontrolled hyperglycemia was highly prevalent among patients with DM. PD patients without DM were in normal range less than half of the time. Hypoglycemia was seen in patients with and without DM. Our findings warrant additional investigation into causes and consequences of glycemic patterns in patients on dialysis. Disclosure L.Mayeda: None. L.Zelnick: None. S.Trikudanathan: Research Support; Insulet Corporation, Bionic pancreas. I.B.Hirsch: Consultant; Abbott Diabetes, Lifecare, Inc., Hagar, Research Support; Beta Bionics, Inc., Insulet Corporation, Dexcom, Inc. S.Watnick: None. I.De boer: Advisory Panel; AstraZeneca, Boehringer Ingelheim and Eli Lilly Alliance, Boehringer Ingelheim International GmbH, Otsuka America Pharmaceutical, Inc., Bayer Inc., Consultant; George Clinical, Gilead Sciences, Inc., Medscape, Research Support; Dexcom, Inc. Funding National Institute of Diabetes and Digestive and Kidney Diseases (R01DK126373)

Bionic pancreas in children and adults with type 1 diabetes

Journal of Paediatrics and Child HealthEarly View Heads UpFree Access Bionic pancreas in children and adults with type 1 diabetes First published: 08 May 2023 https://doi.org/10.1111/jpc.16426 edited by Craig Mellis ([email protected]) AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Unlike currently available semi-automated insulin delivery systems, which require individualised settings and carbohydrate counting, bionic pancreas allows for automated insulin delivery based on body weight and ‘meal announcements’. The Bionic Pancreas Research Group randomised 326 persons with type 1 diabetes aged 6–79 years to insulin-only bionic pancreas treatment (n = 219) or standard care with any insulin-delivery method and unblinded continuous glucose monitoring (n = 107).1 After 13 weeks, the bionic pancreas group saw an HbA1c improving from 7.9% at baseline to 7.3% at follow-up, while standard-treatment group saw no change. Additionally, in the bionic pancreas group, mean sensor glucose improved and time in range (TIR) increased by 11% (Fig. 1). These effects were greater in participants with higher HbA1c and on multiple daily injections or non-automated pump systems. There was no difference in hypoglycaemia (sensor glucose <3 mmol/L). A high rate of adverse events occurred in the bionic pancreas group: hyperglycaemia occurred in 95 participants, predominantly due to infusion-set failures. However, such adverse events were not reported in the standard-treatment group. Of the bionic pancreas group, 19 participants stopped using the intervention prior to completion of the study and two children required additional insulin glargine for hyperglycaemia despite maximal insulin delivery based on the device algorithm. Fig. 1Open in figure viewerPowerPoint (a) Median glucose level over 24 h. Solid circles indicate the hourly median values of the participants' mean glucose levels, and shaded regions indicate the interquartile range; dashed curves indicate the 10th and 90th percentiles. (b) Cumulative distribution plot of the percentage of sensor glucose level in range (3.9–10 mmol/L). (), Standard care; (), bionic pancreas. In conclusion, insulin-only bionic pancreas resulted in lower HbA1c, improved TIR and lower mean sensor glucose level than standard care without increased hypoglycaemia. Further development and optimisation of insulin sets and the insulin delivery algorithm (especially for children) would reduce the risk of adverse events seen in this trial. Reference 1 Bionic Pancreas Research Group et al. Multicenter, randomized trial of a bionic pancreas in type 1 diabetes. N. Engl. J. Med. 2022; 387: 1161– 72. Reviewers: Lara E. Graves, [email protected], The Children's Hospital at Westmead, Sydney; Jessica Sandy, [email protected], The Children's Hospital at Westmead, Sydney Early ViewOnline Version of Record before inclusion in an issue FiguresReferencesRelatedInformation

PID and LQG controllers for diabetes system with internal delay: a comparison study

Closed-loop treatment for insulin dependent type 1 diabetes patients is a recent medical practice in insulin delivery (bionic pancreas) which aims to achieve tight control of glucose level in plasma and ensure minimizing risk of hypoglicemia. Among those most popular closed-loop controller strategies, proportional integral derivative (PID) and linear quadratic Gaussian (LQG) controllers are designed and compared for insulin delivery in diabetic patients. The controllers are designed based on individual and nominal model which is to study the ability of each controller in order to maintain blood glucose concentration for similar patient’s dynamic. The comparison is conducted numerically not only for for patients suffering type 1 diabetes mellitus (T1DM), but also type 2 diabetes mellitus (T2DM), and double diabetes mellitus (DDM) in the present of internal delay systems, which causes instability. The responses show that the proposed PID controller is better at maintaining the blood glucose level in the normal range for a longer delay of delay in hepatic glucose production. The patient with longer performing physical exercise has lower oscillation peaks in blood glucose concentration.

Positive Impact of the Bionic Pancreas on Diabetes Control in Youth 6-17 Years Old with Type 1 Diabetes: A Multicenter Randomized Trial.

Objective: To evaluate the insulin-only configuration of the iLet® bionic pancreas (BP) in youth 6-17 years old with type 1 diabetes (T1D). Research Design and Methods: In this multicenter, randomized, controlled trial, 165 youth with T1D (6-17 years old; baseline HbA1c 5.8%-12.2%; 35% using multiple daily injections, 36% using an insulin pump without automation, 4% using an insulin pump with low glucose suspend, and 25% using a hybrid closed-loop system before the study) were randomly assigned 2:1 to use BP (n = 112) with insulin aspart or insulin lispro (BP group) or to a control group (n = 53) using their personal standard care insulin delivery (SC group) plus real-time continuous glucose monitoring (CGM). The primary outcome was HbA1c at 13 weeks. Results: Mean HbA1c decreased from 8.1% ± 1.2% at baseline to 7.5% ± 0.7% at 13 weeks with BP versus 7.8% ± 1.1% at both baseline and 13 weeks with SC (adjusted difference = -0.5%, 95% CI -0.7% to -0.2%, P < 0.001). Participants with baseline HbA1c ≥9.0% (n = 34) decreased mean HbA1c from 9.7% ± 0.8% to 7.9% ± 0.6% after 13 weeks with BP compared with 9.7% ± 0.5% to 9.8% ± 0.8% with SC. Over 13 weeks, mean time in range (TIR) 70-180 mg/dL increased by 10% (2.4 h per day) and mean CGM glucose was reduced by 15 mg/dL with BP compared with SC (P < 0.001). Analyses of time >180 mg/dL, time >250 mg/dL, and standard deviation of CGM glucose favored BP (P < 0.001). Time <54 mg/dL was low at baseline (median 0.2%) and not significantly different between groups over 13 weeks (P = 0.24). A severe hypoglycemia event occurred in 3 (2.7%) participants in the BP group and in 1 (1.9%) in the SC group. Conclusions: In youth 6-17 years old with T1D, use of insulin-only configuration of BP improved HbA1c, TIR, and hyperglycemic metrics without increasing CGM-measured hypoglycemia compared with standard of care. Improvement in glycemic metrics was most pronounced in participants with high baseline HbA1c levels. Clinical Trial Registry: clinicaltrials.gov; NCT04200313.

A Multicenter Randomized Trial Evaluating the Insulin-Only Configuration of the Bionic Pancreas in Adults with Type 1 Diabetes.

Objective: To evaluate the insulin-only configuration of the iLet® bionic pancreas (BP) using insulin aspart or insulin lispro in adults with type 1 diabetes (T1D). Methods: In this multicenter, randomized, controlled trial, 161 adults with T1D (18-79 years old, baseline HbA1c 5.5%-13.1%, 32% using multiple daily injections, 27% using a pump without automation, 5% using a pump with predictive low glucose suspend, and 36% using a hybrid closed loop system before the study) were randomly assigned 2:1 to use the BP (N = 107) with insulin aspart or insulin lispro (BP group) or a standard-of-care (SC) control group (N = 54) using their usual insulin delivery plus continuous glucose monitoring (CGM). The primary outcome was HbA1c at 13 weeks. Results: Mean HbA1c decreased from 7.6% ± 1.2% at baseline to 7.1% ± 0.6% at 13 weeks with BP versus 7.6% ± 1.2% to 7.5% ± 0.9% with SC (adjusted difference = -0.5%, 95% confidence interval -0.6% to -0.3%, P < 0.001). Over 13 weeks, mean time in range 70-180 mg/dL (TIR) increased by 11% (2.6 h/d) and mean CGM glucose was reduced by 16 mg/dL with BP compared with SC (P < 0.001). Improvement in these metrics was seen during the first day of BP use and by the end of the first week reached levels that remained relatively stable through 13 weeks. Analyses of time >180 mg/dL, time >250 mg/dL, and standard deviation of CGM glucose all favored the BP group (P < 0.001). The CGM-measured hypoglycemia was low at baseline (median time <54 mg/dL of 0.21% [3 min/d] for the BP group and 0.11% [1.6 min/d] for the SC group) and not significantly different between groups over the 13 weeks (P = 0.51 for time <70 mg/dL and 0.33 for time <54 mg/dL). There were 7 (6.5% of 107 participants) severe hypoglycemic events in the BP group and 2 events in the SC group (1.9% of 54 participants, P = 0.40). Conclusions: In adults with T1D, use of the BP with insulin aspart or insulin lispro improved HbA1c, TIR, and hyperglycemic metrics without increasing CGM-measured hypoglycemia compared with standard of care. Clinical Trial Registry: clinicaltrials.gov; NCT04200313.

The Insulin-Only Bionic Pancreas Pivotal Trial Extension Study: A Multi-Center Single-Arm Evaluation of the Insulin-Only Configuration of the Bionic Pancreas in Adults and Youth with Type 1 Diabetes.

Objective: To evaluate a transition from standard-of-care (SC) management of type 1 diabetes (any insulin delivery method including hybrid closed-loop systems plus real-time continuous glucose monitoring [CGM]) to use of the insulin-only configuration of the iLet® bionic pancreas (BP) in 90 adults and children (age 6-71 years). Research Design and Methods: After the SC group completed the randomized controlled trial (RCT) portion of the Insulin-Only BP Pivotal Trial, 90 of the 107 participants participated in a 13-week study using the BP. The key outcomes were change from baseline in HbA1c and CGM metrics after 13 weeks on the BP. Results: Using the BP, mean HbA1c decreased from 7.7% ± 1.0% (61 ± 10.9 mmol/mol) at baseline to 7.1% ± 0.6% (54 ± 6.6 mmol/mol) at 13 weeks (mean change -0.55% ± 0.72% [-6 ± 7.9 mmol/mol], P < 0.001), time in range 70-180 mg/dL increased by 12.0% ± 12.5% (from 53% ± 17% to 65% ± 9%, P < 0.001), and mean glucose decreased by -18 ± 23 mg/dL (from 182 ± 32 to 164 ± 15 mg/dL, P < 0.001). The higher the baseline HbA1c level, the greater the change in HbA1c. Results were similar in the adult (N = 42) and pediatric (N = 48) cohorts. Time <70 mg/dL decreased from baseline over the 13 weeks by -0.50% ± 1.86% (P = 0.02), and time <54 mg/dL was similar (change from baseline -0.08% ± 0.59%, P = 0.24). Two severe hypoglycemia events (in same participant) and one diabetic ketoacidosis event occurred. Conclusions: Glycemic control improved after adult and pediatric participants in the SC arm in the Insulin-Only BP Pivotal Trial transitioned to use of the BP. Improvement using the BP was of similar magnitude to that observed during the RCT. ClinicalTrials.gov number, NCT04200313.

A Multicenter Randomized Trial Evaluating Fast-Acting Insulin Aspart in the Bionic Pancreas in Adults with Type 1 Diabetes.

Objective: To evaluate the insulin-only configuration of the iLet® bionic pancreas (BP) using fast-acting insulin aspart (Fiasp®) in adults with type 1 diabetes (T1D). Research Design and Methods: In this multicenter, randomized trial, 275 adults with T1D (18-83 years old, baseline HbA1c 5.3%-14.9%) were randomly assigned 2:2:1 to use the BP with fast-acting insulin aspart (BP-F group, N = 114), BP with aspart or lispro (BP-A/L group, N = 107), or a control group using their standard-care insulin delivery (SC group, N = 54) plus real-time continuous glucose monitoring (CGM). The primary outcome was HbA1c at 13 weeks. The BP-F versus SC comparison was considered primary and BP-F versus BP-A/L secondary. Results: Mean ± standard deviation (SD) HbA1c decreased from 7.8% ± 1.2% at baseline to 7.1% ± 0.6% at 13 weeks with BP-F versus 7.6% ± 1.2% to 7.5% ± 0.9% with SC (adjusted difference = -0.5%, 95% CI -0.7 to -0.3, P < 0.001). CGM-measured percent time <54 mg/dL over 13 weeks with BP-F was noninferior to SC (adjusted difference = 0.00%, 95% CI -0.07 to 0.05, P < 0.001 for noninferiority based on a prespecified noninferiority limit of 1%). Over 13 weeks, mean time in range 70-180 mg/dL (TIR) increased by 14% (3.4 h/day) and mean CGM glucose was reduced by 18 mg/dL with BP-F compared with SC (P < 0.001). Analyses of time >180 mg/dL, time >250 mg/dL, and the SD of CGM glucose all favored BP-F compared with SC (P < 0.001). Differences between BP-F and BP-A/L were minimal, with no difference in HbA1c at 13 weeks (adjusted difference = -0.0%, 95% CI -0.2 to 0.1, P = 0.67) or mean glucose (adjusted difference = -2.0 mg/dL, 95% CI -4.3 to 0.4, P = 0.10). Mean TIR was 2% greater with BP-F than BP-A/L (95% CI 1 to 4, P = 0.005), but the percentages of participants improving TIR by ≥5% were not significantly different (P = 0.49) and there were no significant differences comparing BP-F versus BP-A/L across nine patient-reported outcome surveys. The rate of severe hypoglycemia events did not differ among the three groups. Conclusions: In adults with T1D, HbA1c was improved with the BP using fast-acting insulin aspart compared with standard care without increasing CGM-measured hypoglycemia. However, the effect was no better than the reduction observed with the BP using aspart or lispro. Clinical Trial Registry: clinicaltrials.gov; NCT04200313.

9 Automated insulin delivery with the iLet bionic pancreas for the management of cystic fibrosis–related diabetes

9 Automated insulin delivery with the iLet bionic pancreas for the management of cystic fibrosis–related diabetes

Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes

BackgroundCurrently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting.MethodsIn this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed.ResultsA total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, −0.5 percentage points; 95% confidence interval [CI], −0.6 to −0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, −0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P=0.39). No episodes of diabetic ketoacidosis occurred in either group.ConclusionsIn this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT04200313.)

The bihormonal bionic pancreas improves glycemic control in individuals with hyperinsulinism and postpancreatectomy diabetes: a pilot study

The bihormonal bionic pancreas improves glycemic control in individuals with hyperinsulinism and postpancreatectomy diabetes: a pilot study