MiniMed 670G Hybrid Closed-loop System Research Articles

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.

Study Design and Data Analysis of Artificial Pancreas Device Systems with Closed-Loop Glucose-Sensing Insulin Delivery

Objective The objective of this article is to provide a high-profile review and discussion on the study design and statistical analysis of pivotal clinical trials conducted to demonstrate the safety and effectiveness of closed-loop investigational artificial pancreas device systems (APDSs) in premarket approval applications. Methods The United States Food and Drug Administration (FDA) guidance on the content of investigational device exemption and premarket approval applications for APDSs is reviewed with special emphasis on study design and statistical analysis of the pivotal clinical trials. The two pivotal studies for the MiniMed 670G hybrid closed-loop system by Medtronic in their premarket approval application are summarized and discussed. Results The United States FDA established detailed recommendations on the study design and statistical analysis of pivotal clinical trials for the industry that seek market investigational APDSs and for FDA scientific reviewers that regulate the device applications. The recommendations cover specifics regarding patient population, clinical endpoints, and strategies for data analysis. However, the two pivotal studies that demonstrated the effectiveness of the FDA-approved MiniMed 670G hybrid closed-loop system were not typical randomized controlled trials as per FDA recommendations. Conclusion The development and regulation of investigational APDSs require careful and sophisticated clinical study designs and data analysis in premarket approval applications. The regulatory evaluation process of the APDSs is rather complicated since the devices consist of multiple components that collaboratively function to mimic human pancreases.

A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial

Management of type 1 diabetes is challenging. We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes. In this multinational, randomised, crossover trial (Fuzzy Logic Automated Insulin Regulation [FLAIR]), individuals aged 14-29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA1c) levels of 7·0-11·0% (53-97 mmol/mol) were recruited from seven academic-based endocrinology practices, four in the USA, and one each in Germany, Israel, and Slovenia. After a run-in period to teach participants how to use the study pump and continuous glucose monitor, participants were randomly assigned (1:1) using a computer-generated sequence, with a permuted block design (block sizes of two and four), stratified by baseline HbA1c and use of a personal MiniMed 670G system (Medtronic) at enrolment, to either use of a MiniMed 670G hybrid closed-loop system (670G) or the investigational advanced hybrid closed-loop system (Medtronic) for the first 12-week period, and then participants were crossed over with no washout period, to the other group for use for another 12 weeks. Masking was not possible due to the nature of the systems used. The coprimary outcomes, measured with continuous glucose monitoring, were proportion of time that glucose levels were above 180 mg/dL (>10·0 mmol/L) during 0600 h to 2359 h (ie, daytime), tested for superiority, and proportion of time that glucose levels were below 54 mg/dL (<3·0 mmol/L) calculated over a full 24-h period, tested for non-inferiority (non-inferiority margin 2%). Analysis was by intention to treat. Safety was assessed in all participants randomly assigned to treatment. This trial is registered with ClinicalTrials.gov, NCT03040414, and is now complete. Between June 3 and Aug 22, 2019, 113 individuals were enrolled into the trial. Mean age was 19 years (SD 4) and 70 (62%) of 113 participants were female. Mean proportion of time with daytime glucose levels above 180 mg/dL (>10·0 mmol/L) was 42% (SD 13) at baseline, 37% (9) during use of the 670G system, and 34% (9) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -3·00% [95% CI -3·97 to -2·04]; p<0·0001). Mean 24-h proportion of time with glucose levels below 54 mg/dL (<3·0 mmol/L) was 0·46% (SD 0·42) at baseline, 0·50% (0·35) during use of the 670G system, and 0·46% (0·33) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -0·06% [95% CI -0·11 to -0·02]; p<0·0001 for non-inferiority). One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group. Hyperglycaemia was reduced without increasing hypoglycaemia in adolescents and young adults with type 1 diabetes using the investigational advanced hybrid closed-loop system compared with the commercially available MiniMed 670G system. Testing an advanced hybrid closed-loop system in populations that are underserved due to socioeconomic factors and testing during pregnancy and in individuals with impaired awareness of hypoglycaemia would advance the effective use of this technology FUNDING: National Institute of Diabetes and Digestive and Kidney Diseases.

Real world hybrid closed-loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months

OBJECTIVE To describe predictors of hybrid closed loop (HCL) discontinuation and perceived barriers to use in youth with type 1 diabetes. SUBJECTS Youth with type 1 diabetes (eligible age 2-25 y; recruited age 8-25 y) who initiated the Minimed 670G HCL system were followed prospectively for 6 mo in an observational study. RESEARCH DESIGN AND METHODS Demographic, glycemic (time-in-range, HbA1c), and psychosocial variables [Hypoglycemia Fear Survey (HFS); Problem Areas in Diabetes (PAID)] were collected for all participants. Participants who discontinued HCL (<10% HCL use at clinical visit) completed a questionnaire on perceived barriers to HCL use. RESULTS Ninety-two youth (15.7 ± 3.6 y, HbA1c 8.8 ± 1.3%, 50% female) initiated HCL, and 28 (30%) discontinued HCL, with the majority (64%) discontinuing between 3 and 6 mo after HCL start. Baseline HbA1c predicted discontinuation (P = .026) with the odds of discontinuing 2.7 times higher (95% CI: 1.123, 6.283) for each 1% increase in baseline HbA1c. Youth who discontinued HCL rated difficulty with calibrations, number of alarms, and too much time needed to make the system work as the most problematic aspects of HCL. Qualitatively derived themes included technological difficulties (error alerts, not working correctly), too much work (calibrations, fingersticks), alarms, disappointment in glycemic control, and expense (cited by parents). CONCLUSIONS Youth with higher HbA1c are at greater risk for discontinuing HCL than youth with lower HbA1c, and should be the target of new interventions to support device use. The primary reasons for discontinuing HCL relate to the workload required to use HCL.

Patient Satisfaction and Clinical Experience With MiniMed 670G Hybrid Closed-Loop System

Patient Satisfaction and Clinical Experience With MiniMed 670G Hybrid Closed-Loop System

233-OR: Ultra-Rapid Lispro (URLi) Demonstrates Similar Time-in-Target Range to Humalog with the Medtronic MiniMed 670G Hybrid Closed-Loop System

URLi is a novel ultra rapid formulation of insulin lispro that shows improved postprandial glucose control and similar compatibility with continuous subcutaneous insulin infusion (CSII) vs. Humalog. In this study URLi was evaluated for the first time in a hybrid closed-loop system using the Medtronic MiniMed 670G. Primary objective was to compare URLi to Humalog with respect to the percentage of time with glucose values within target range 70-180 mg/dL (%TIR). This double-blind, crossover study included two 4-week treatment periods with URLi or Humalog. After a 2-week lead-in on Humalog, 42 adults with type 1 diabetes using personal MiniMed 670G pumps were randomized to 1 of the 2 treatment sequences with boluses initiated 0-2 minutes before meals. Both treatments achieved good glycemic control with mean TIR &amp;gt;75% (Fig 1). Mean time above and below range met consensus recommendations for both treatments. The percentage of time in Auto Mode was similar between treatments: URLi 92.0%; Humalog 91.4%. Insulin doses and pump settings were generally similar between treatments. There were no serious adverse events or early discontinuations. Overall incidence of treatment-emergent adverse events was similar between treatments. URLi demonstrated comparable glycemic control and a similar safety profile to Humalog with the MiniMed 670G system in patients with type 1 diabetes. Disclosure B.W. Bode: Advisory Panel; Self; InPen, Medtronic. Consultant; Self; ADOCIA, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Novo Nordisk A/S, Pfizer Inc. Research Support; Self; Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Gan &amp; Lee Pharmaceuticals, Medtronic, Novo Nordisk A/S, Provention Bio, Inc., Senseonics, Xeris Pharmaceuticals, Inc. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., InPen, Janssen Pharmaceuticals, Inc., MannKind Corporation, Medtronic, Novo Nordisk A/S, Sanofi, Sanofi, Senseonics, Xeris Pharmaceuticals, Inc. Stock/Shareholder; Self; Glytec. A.L. Carlson: Consultant; Self; Medtronic. Research Support; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic, Novo Nordisk A/S, Sanofi, UnitedHealth Group. R. Liu: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; Eli Lilly and Company. T. Hardy: Other Relationship; Self; Eli Lilly and Company. J. Boyd: None. R.M. Bergenstal: Consultant; Self; Ascensia Diabetes Care, Johnson &amp; Johnson. Other Relationship; Self; Abbott, Dexcom, Inc., Hygieia, Lilly Diabetes, Medtronic, Novo Nordisk A/S, Onduo, Roche Diabetes Care, Sanofi, UnitedHealth Group. S. Morrett: Other Relationship; Self; Eli Lilly and Company. D.A. Ignaut: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. Funding Eli Lilly and Company

Glucose control during Ramadan fasting in a teenager with type 1 diabetes on MiniMed 670G hybrid closed-loop system

Glucose control during Ramadan fasting in a teenager with type 1 diabetes on MiniMed 670G hybrid closed-loop system

1075-P: Safety and Efficacy of Medtronic MiniMed 670G Hybrid Closed-Loop System in the Diabetes Camp Setting: Comparison of Auto Mode (AM) vs. Manual Mode (MM)

Introduction: The Medtronic MiniMed 670G insulin pump is the first FDA approved commercial hybrid closed-loop system for pediatric patients with type 1 diabetes (T1D). Clinical trials have shown that the pump’s Auto Mode system effectively maintains blood glucose (BG) levels in target ranges for longer periods of time. Campers may have different insulin requirements than they are accustomed to at home due to the different foods and activity levels at camp. In this retrospective quality review, Medtronic MiniMed 670G pump data from campers attending 2018 ADA Camp MIDICHA were analyzed to investigate the safety and efficacy of campers in AM vs. MM. Methods: We analyzed de-identified data from 34 campers (mean age 13.1 years [range 8-17]). There were 18 MM and 16 AM campers. BG levels, grams of carbohydrates consumed, and amount of insulin administered were recorded at every meal, evening snack, 12AM, and 2AM. The number of hypoglycemic events (&amp;lt;70 mg/dL), hyperglycemic events (&amp;gt;250 mg/dL), and events within the target BG range (70-250 mg/dL) were also noted. Results: Our results showed improved glycemic control for campers in AM at breakfast (AM 166.56 mg/dL, MM 182.50 mg/dL), lunch (AM 156.08 mg/dL, MM 167.67 mg/dL), dinner (AM 191.83 mg/dL, MM 194.22 mg/dL), and evening snack (AM 164.13 mg/dL, MM 179.19 mg/dL). Average daily BG was lower for AM (AM 162.12 mg/dL, MM 173.54 mg/dL). The number of hypoglycemic events was 37 for AM and 38 for MM. The number of hyperglycemic events was 62 for AM and 80 for MM. Discussion: Compared to MM, using the AM system allowed for a higher percentage of BG in the target range and decreased incidences of hypoglycemic and hyperglycemic events. This suggests that the AM system in the Medtronic MiniMed 670G insulin pump can safely and effectively maintain target BG levels for children with T1D in camp settings. Disclosure S.H. Chan: None. E.W. Chang: None. J.K. Tang: None. L. Schmeltz: Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Eli Lilly and Company, Merck &amp; Co., Inc., Novo Nordisk Inc.

Medtronic MiniMed 670G Hybrid Closed-Loop System.

New and improved technologies for the treatment of diabetes continue to emerge at an impressive rate. Recent advancements in insulin delivery and continuous glucose monitoring (CGM) have made a particularly meaningful impact on the care and treatment burden of many people living with type 1 diabetes (T1D) (1). One such advancement is the development and approval of the Medtronic MiniMed 670G hybrid closed-loop (670G HCL) system (Medtronic Diabetes, Northridge, Calif.) (2). This brief monograph will highlight key functions of the 670G HCL system and discuss potential advantages and disadvantages of the system. The 670G HCL system was initially approved by the U.S. Food and Drug Administration in September 2017 for use in people with T1D who are ≥14 years of age. In June 2018, the indication for the system was expanded to include people with T1D between the ages of 7 and 13 years (2). The 670G HCL system is composed of the MiniMed 670G insulin pump and the Guardian Sensor 3 CGM package (3). The system can function in two different modes: “auto mode” and “manual mode.” When in auto mode, the system uses an algorithm capable of automatically adjusting basal insulin delivery in response to CGM readings transmitted to the insulin pump every 5 minutes (4,5). While in …

Optimizing a Hybrid Closed Loop System in Type 1 Diabetes: A Case Report.

We present the optimization of a hybrid closed-loop (HCL) insulin pump system in a type 1 diabetes (T1D) patient in the first 3 months of using the Minimed 670G. An 11-year-old female with 7 years of T1D history started using the Minimed 670G HCL system at our center. The patient had been using the Medtronic Veo insulin pump without a sensor for almost 4 years with HbA1c levels between 7.8% and 10.2%. We introduced the Minimed 670G to improve overall glucose control, improve quality of life and lessen the diabetes burden. Insulin pump characteristics of the Minimed Veo pump were used as the initial setting in the HCL system. The optimization of the Minimed 670G in the next 3 months led to the following changes: an insulin-to-carbohydrate ratio (ICHR) from 1 to 10 g in the morning period (6 a.m. to 12 a.m.) and 15–12 g for the rest of the day (12 p.m. to 6 a.m.); an active insulin time from 4 to 3 h and insulin sensitivity factor (ISF) from 120 to 90 mg/dl with no change in target range. The HbA1c level decreased by − 1.3%, and the time in range significantly increased to 77% with SG values of 139 ± 60 mg/dl, sensor wear of 82% and an auto mode period of 84% per week. Health providers should consider immediate adjustment of the bolus wizard settings such as the ICHR, ISF and active insulin time. The HCL system can improve overall glucose control with increased time in the range of sensor glucose values and reduction of HbA1c levels.

Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol

IntroductionManual determination of insulin dosing largely fails to optimise glucose control in type 1 diabetes. Automated insulin delivery via closed-loop systems has improved glucose control in short-term studies. The objective...

Abstract #1212 Real Life Efficacy of the Minimed 670g Hybrid Closed-Loop System in an Endocrine Outpatient Clinic

Abstract #1212 Real Life Efficacy of the Minimed 670g Hybrid Closed-Loop System in an Endocrine Outpatient Clinic

Clinical Use of Continuous Glucose Monitoring in Pediatrics.

The first reported clinical use of a continuous glucose monitoring (CGM) system in children was by Coss-Buet al. in 1999.1 They investigated a bedside VIA 1-01G Blood Chemistry monitor for measuring glucose in the pediatric intensive care unit (PICU). The monitor was programmed to draw venous blood, analyze, and record blood glucose samples automatically at predetermined intervals. This system was large, difficult to move, required intravenous access, and took 20 min to set up. Nonetheless, the data provided were comparable to measures by a laboratory glucose analyzer and bedside glucometer and could be used to inform clinical decision-making. Many advances have occurred since that time to benefit pediatric patients with diabetes. Most recently, the FDA has approved the Dexcom G5 CGM system for use in insulin dosing decisions (nonadjunctive use),2 the MiniMed 670G hybrid closed-loop system which alters insulin delivery based on CGM data for children ≥14 years of age,3 and the Abbott FreeStyle Libre Pro for use by healthcare providers in tracking glucose data for those 18 years and over.4 In this chapter, published Pediatric data on CGM use will be reviewed in the following areas: type 1 and 2 diabetes mellitus, prediabetes, cystic fibrosis, neonatology, adrenal insufficiency, glycogen storage disease, and critical illness. Data were obtained through review of published works from a PubMed search of “pediatric continuous glucose monitor.” We also review pediatric CGM data from artificial pancreas studies, a rapidly evolving field with great promise to reduce burden and improve glucose control in pediatric patients.