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Background: Safety and significant improvement in overall glycated hemoglobin (A1C) and percentage of time spent in (TIR), below (TBR), and above (TAR) glucose range were demonstrated in the pivotal trial of adolescents and adults using the MiniMed™ advanced hybrid closed-loop (AHCL) system with the adjunctive, calibration-required Guardian™ Sensor 3. The present study evaluated early outcomes of continued access study (CAS) participants who transitioned from the pivotal trial investigational system to the approved MiniMed™ 780G system with the non-adjunctive, calibration-free Guardian™ 4 Sensor (MM780G+G4S). Study data were presented alongside those of real-world MM780G+G4S users from Europe, the Middle East, and Africa. Methods: The CAS participants (N = 109, aged 7–17 years and N = 67, aged >17 years) used the MM780G+G4S for 3 months and data of real-world MM780G+G4S system users (N = 10,204 aged ≤15 years and N = 26,099 aged >15 years) were uploaded from September 22, 2021 to December 02, 2022. At least 10 days of real-world continuous glucose monitoring (CGM) data were required for analyses. Glycemic metrics, delivered insulin and system use/interactions underwent descriptive analyses. Results: Time in AHCL and CGM use were >90% for all groups. AHCL exits averaged 0.1/day and there were few blood glucose measurements (BGMs) (0.8/day–1.0/day). Adults in both cohorts met most consensus recommendations for glycemic targets. Pediatric groups met recommendations for %TIR and %TBR, although not those for mean glucose variability and %TAR, possibly due to low use of recommended glucose target (100 mg/dL) and active insulin time (2 h) settings (28.4% in the CAS cohort and 9.4% in the real-world cohort). The CAS pediatric and adult A1C were 7.2% ± 0.7% and 6.8% ± 0.7%, respectively, and there were no serious adverse events. Conclusions: Early clinical use of the MM780G+G4S was safe and involved minimal BGMs and AHCL exits. Consistent with real-world pediatric and adult use, outcomes were associated with achievement of recommended glycemic targets. Clinical Trial Registration number: NCT03959423 [ABSTRACT FROM AUTHOR]

Background: The coronavirus disease 2019 (COVID-19) pandemic has challenged the ability to do face-to-face training on advanced diabetes management technologies. In the United States, Medtronic Diabetes shifted from occasional to 100% virtual training on all diabetes devices in mid-March 2020. We studied the outcomes of virtual training on the MiniMed™ 670 G hybrid closed-loop system in type 1 diabetes. Methods: From March 20, 2020, to April 22, 2020 (intra-COVID-19), virtual training on the MiniMed 670 G system was completed using Zoom with satisfaction captured through online post-training surveys. Training efficiency was measuring by the days between the date of product shipment and the date of the first and final trainings. Patient satisfaction with training on the MiniMed 670 G was determined by Net Promotor Score® (NPS®). Uploads from CareLink™ Personal and CareLink Professional and calls to the Medtronic 24-h technical support team requesting educational/software assistance and/or help with health care provider telehealth visits were recorded. Continuous glucose monitoring (CGM) results were measured using the CareLink Personal database. All results except for the Zoom satisfaction survey were compared with data from January 20, 2020, to February 22, 2020, (Pre-COVID-19) when training was performed in-person. Results: The CGM metrics were comparable between pre- and intra-COVID-19 training. The Zoom video conferencing application had 98% satisfaction. The NPS rose from 78 to 84. The time between the pump shipment and the first and last (automode) training was significantly reduced from 14 ± 7 days to 11 ± 5 days (P < 0.001) and from 19 ± 7 days to 15 ± 15 days (P < 0.01), respectively. There was a decrease in the calls for educational assistance to the technical support team but an increase in requests for login and software installation support. Conclusions: Virtual training of individuals with diabetes on the MiniMed 670 G system resulted in high satisfaction and short-term glycemic results comparable with in-person training. [ABSTRACT FROM AUTHOR]

A 3-month pivotal trial using the MiniMed™ 670G hybrid closed-loop (HCL) system in adolescent and adult patients with type 1 diabetes (T1D), relative to a 2-week baseline run-in period, resulted in increased sensor glucose (SG) values in target range (71-180 mg/dL), reduced HbA1c levels, and no events of diabetic ketoacidosis or severe hypoglycemia ( Clinicaltrials.gov : NCT02463097). This brief report evaluated how prior continuous glucose monitoring (CGM) experience influenced glycemic outcomes, in the same pivotal trial. HbA1c levels and the percentage of SG values in low, high, and in-target ranges were analyzed from participants (n = 124) completing the Hybrid Closed-Loop Pivotal Trial in T1D. There were 78 individuals comprising the prior CGM group and 46 comprising the no prior CGM group. Compared to baseline, HbA1c was reduced from 7.4% ± 0.9% to 6.9% ± 0.7% for the prior CGM group and from 7.5% ± 0.9% to 6.8% ± 0.5% for the no prior CGM group. For those with prior CGM experience, the mean percentage of in-target SG values increased from 66.9% ± 12.5% to 72.6% ± 9.1%, and for those with no prior CGM experience it increased from 66.6% ± 11.7% to 71.5% ± 8.5%. Similar improvement in glucose values in the low and high ranges, relative to baseline, was observed for both groups. Resulting outcomes, from baseline to study end, did not differ between each group. These findings suggest that individuals without prior CGM experience, and those already using CGM, will benefit similarly with use of the FDA-approved MiniMed 670G HCL system therapy. [ABSTRACT FROM AUTHOR]

Continuous glucose monitoring data can be reviewed, analyzed, and ultimately leveraged for diabetes treatment decision making. The Glucose Management Indicator (GMI) which determines an average A1C level based on mean continuous glucose monitoring data (Bergenstal RM, et al. 2018;41:2275-2280) was evaluated alongside time in target glucose range (TIR) during MiniMed™ 670G system use by over 3,000 real-world individuals living with diabetes. MiniMed™ 670G system data from individuals with T1D aged 14-22 years (n=291) and >22 years (n= 3174) were voluntarily uploaded from 3/17/2017 to 12/17/2018, de-identified, and analyzed if captured over the course of ≥365 days. The percentage of time in Auto Mode, TIR (70-180 mg/dL [3.9-10.0 mmol/L]) and time spent in hypoglycemia (<54 mg/dL [3.0 mmol/L]) were assessed alongside the GMI (3.31 + 0.02392 x [mean glucose in mg/dL]), 7-10 days after starting SmartGuard™ Auto Mode use. Over the analysis period, the median (min-max) of Auto Mode use was 77% (70.0-85.5%) in the >22 years cohort, and 62% (50.4-75.0%) in the younger cohort. In both cohorts, the mean TIR was above 70.0% and the time spent at <54 mg/dL stayed below 1.0% (<14min). The GMI for the older and younger cohorts was on an average 6.9% and 7.3% respectively, which is under 7.0% and 7.5%, meeting ADA recommended A1C targets for adult and pediatric age groups with diabetes, respectively. These findings indicate maintained glycemic control with concomitant Auto Mode usage and TIR, without increasing hypoglycemia, in real-world settings for individuals living with T1D and using the MiniMed™ 670G system. Disclosure: S. Gopalakrishnan: Employee; Self; Medtronic. T.L. Cordero: Employee; Self; Medtronic. M. Sadeghzadeh: Employee; Self; Medtronic. M. Stone: None. P. Agrawal: Employee; Self; Medtronic MiniMed, Inc. Stock/Shareholder; Self; Medtronic. [ABSTRACT FROM AUTHOR]

Background: The MiniMed™ 670G system targets glucose levels to 120mg/dL (6.7mmol/L) and has a temporary target (TT) of 150mg/dL (8.3mmol/L) that can be set from 2-12 hours. An exploratory analysis of glycemic outcomes and TT use during the 3-month MiniMed™ 670G system pivotal trials was conducted. Methods: Data from 151 children (n=46, 2-6 years and n=105, 7-13 years) and 124 adolescents and adults (n=30, 14-21 years and n=94, 22-75 years) during 2-week Manual Mode use (run-in), followed by 3-month Auto Mode use (study), were analyzed by percentage of TT use. Results: The median (IQR) of TT use for those 2-6 years was 4.1% (0.6-16.3%); for 7-13 years was 0.4% (0-2.1%) and ≥14 years was 0.4% (0-1.2%). Glycemic outcomes for the 2-6 years are shown by percentage of TT use (<4% or ≥4%). A trend in baseline data show that the ≥4% group had less hypoglycemia (3.0% vs. 4.3%) and more hyperglycemia (44.9% vs. 36.8%), suggesting preemptive hypoglycemia avoidance. Conclusions: Improved glycemia was observed in the 2-6 years group regardless of TT use during study phase, compared to baseline run-in. The higher glucose target was used more often in the youngest cohort, suggesting the TT feature is important for young children with T1D using automated insulin delivery. Disclosure: J. Shin: Employee; Self; Medtronic. X. Chen: None. T.L. Cordero: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic. [ABSTRACT FROM AUTHOR]

Background: The MiniMed™ 670G system is FDA-approved and CE-marked for patients with T1D aged ≥7 years. Glycemic outcomes of patients aged 2-75 years with T1D using the system at home for 3 months were evaluated and compared. Methods: Data from 151 children (n=46, 2-6 years and n=105, 7-13 years) enrolled at 9 sites; and 124 adolescents and adults (n=30, 14-21 years and n=94, 22-75 years) enrolled at 10 sites, during 2-week Manual Mode use (run-in phase) followed by 3-month Auto Mode use (study phase) were analyzed. Glycemic outcomes (HbA1c, time spent at sensor glucose [SG] ranges, SG, and SG variability, etc.) were compared across age groups. Results: Data from run-in and study phases are shown (Table). Across age groups there was a 0.4% to 0.5% decrease in HbA1c and a 5.5% to 8.8% increase in time in range. During the study phases of the pediatric (2-13 years) and older cohort (14-75 years) trials, there were no episodes of severe hypoglycemia or DKA, and no serious device-related adverse events. Conclusions: These findings indicate that 3-month MiniMed™ 670G Auto Mode use in patients as young as two years of age with T1D, similar to older cohorts using the system, can safely improve glycemic outcomes compared to 2-week open-loop Manual Mode. Disclosure: T.S. Bailey: Advisory Panel; Self; Abbott. Consultant; Self; Capillary Biomedical, Inc., Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Sanofi. Research Support; Self; Abbott, Ascensia Diabetes Care, Becton, Dickinson and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Calibra Medical, Capillary Biomedical, Inc., Companion Medical, Dance Biopharm Holdings Inc., Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, GlySens Incorporated, Kowa Pharmaceutical Europe Co. Ltd., Lexicon Pharmaceuticals, Inc., Medtronic, Novo Nordisk Inc., POPS! Diabetes Care, POPS! Diabetes Care, Sanofi, Senseonics, vTv Therapeutics, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. Speaker's Bureau; Self; Abbott, MannKind Corporation, Medtronic, Novo Nordisk Inc., Sanofi US, Senseonics. B.W. Bode: Consultant; Self; ADOCIA, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc. Research Support; Self; Becton, Dickinson and Company, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Eyenuk Inc., Insulet Corporation, National Institutes of Health, Novo Nordisk Inc., Sanofi Research & Development, Senseonics, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US, Senseonics. Stock/Shareholder; Self; AgaMatrix, Glytec, LLC. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Novo Nordisk Inc., Profusa, Inc. Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Beta Bionics, ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. Other Relationship; Self; Insulet Corporation, Tandem Diabetes Care. G.P. Forlenza: Advisory Panel; Self; Dexcom, Inc. Consultant; Self; Medtronic MiniMed, Inc., Tandem Diabetes Care. Research Support; Self; Dexcom, Inc., Insulet Corporation, Medtronic MiniMed, Inc., Tandem Diabetes Care. O. Pinhas-Hamiel: None. K.K. Kaiserman: Consultant; Self; Medtronic MiniMed, Inc. Research Support; Self; Medtronic MiniMed, Inc. Speaker's Bureau; Self; Medtronic MiniMed, Inc. D.R. Liljenquist: None. D.I. Shulman: None. M.A. Wood: None. X. Chen: None. J. Shin: Employee; Self; Medtronic. T.L. Cordero: Employee; Self; Medtronic. S.W. Lee: Employee; Self; Medtronic. F.R. Kaufman: Employee; Self; Medtronic. [ABSTRACT FROM AUTHOR]

Background: During MiniMed™ advanced hybrid closed-loop (AHCL) use by adolescents and adults in the pivotal trial, glycated hemoglobin (A1C) was significantly reduced, time spent in range (TIR) was significantly increased, and there were no episodes of severe hypoglycemia or diabetic ketoacidosis (DKA). The present study investigated the same primary safety and effectiveness endpoints during AHCL use by a younger cohort with type 1 diabetes (T1D). Methods: An intention-to-treat population ( N  = 160, aged 7-17 years) with T1D was enrolled in a single-arm study at 13 investigational centers. There was a run-in period (∼25 days) using HCL or sensor-augmented pump with/without predictive low-glucose management, followed by a 3-month study period with AHCL activated at two glucose targets (GTs; 100 and 120 mg/dL) for ∼45 days each. The mean ± standard deviation values of A1C, TIR, mean sensor glucose (SG), coefficient of variation (CV) of SG, time at SG ranges, and insulin delivered between run-in and study were analyzed (Wilcoxon signed-rank test or t -test). Results: Compared with baseline, AHCL use was associated with reduced A1C from 7.9 ± 0.9% ( N  = 160) to 7.4 ± 0.7% ( N  = 136) ( P  < 0.001) and overall TIR increased from the run-in 59.4 ± 11.8% to 70.3 ± 6.5% by end of study ( P  < 0.001), without change in CV, time spent below range (TBR) <70 mg/dL, or TBR <54 mg/dL. Relative to longer active insulin time (AIT) settings ( N  = 52), an AIT of 2 h ( N  = 19) with the 100 mg/dL GT increased mean TIR to 73.4%, reduced TBR <70 mg/dL from 3.5% to 2.2%, and reduced time spent above range (TAR) >180 mg/dL from 28.7% to 24.4%. During AHCL use, there was no severe hypoglycemia or DKA. Conclusions: In children and adolescents with T1D, MiniMed AHCL system use was safe, A1C was lower, and TIR was increased. The lowest GT and shortest AIT were associated with the highest TIR and lowest TBR and TAR, all of which met consensus-recommended glycemic targets. ClinicalTrials.gov ID: NCT03959423.

Background: Glycemic outcomes during real-world hybrid closed-loop (HCL) system use by individuals with type 1 diabetes, in the United States, were retrospectively analyzed., Methods: Hybrid closed-loop system data voluntarily uploaded to Carelink™ personal software from March 2017 to November 2020 by individuals (aged ≥7 years) using the MiniMed™ 670G system and having ≥10 days of continuous glucose monitoring data after initiating Auto Mode were assessed. Glycemic outcomes including the mean glucose management indicator (GMI), sensor glucose (SG), percentage of time spent in (TIR), below (TBR), and above (TAR) target range (70-180 mg/dL) were analyzed. Outcomes were also analyzed in a subgroup of users per baseline GMI of <7% versus >8%., Results: The overall cohort (N = 123 355 users, with a mean of 87.9% of time in Auto Mode) had a GMI of 7.0% ± 0.4%, TIR of 70.4% ± 11.2%, TBR <70 mg/dL of 2.2% ± 2.1% and TAR>180 mg/dL of 27.5% ± 11.6%, post-Auto Mode initiation. Compared with pre-Auto Mode initiation, users (N = 52 941, 88.6% of time in Auto Mode) had a GMI that decreased from 7.3% ± 0.6% to 7.1% ± 0.5% ( P < .001), TIR that increased from 61.5% ± 15.1% to 68.1% ± 11.9% ( P < .001), TAR>180 mg/dL that decreased from 36.3% ± 15.7% to 29.8% ± 12.2% ( P < .001) and TBR<70 mg/dL that decreased from 2.11 ± 2.4 to 2.07% ± 2.25% ( P = .002). While all metrics statistically improved for the baseline GMI >8.0% group, the baseline GMI <7.0% group had unchanged TIR (77.4% ± 7.4% to 77.5% ± 8.0%, P = .456) and TAR>180 mg/dL that increased (19.2 ± 6.7 to 19.6 ± 7.9%, p < 0.001)., Conclusion: Real-world HCL system use in the U.S. demonstrated overall glycemic control that trended similarly with the system pivotal trial outcomes and previous real-world system use analyses.

Objective: To evaluate safety and effectiveness of MiniMed™ 670G hybrid closed loop (HCL) in comparison with continuous subcutaneous insulin infusion (CSII) therapy for 6 months in persons with type 1 diabetes (T1D). Methods: Adults (aged 18-80 years), adolescents, and children (aged 2-17 years) with T1D who were using CSII therapy were enrolled and randomized (1:1) to 6 months of HCL intervention (n = 151, mean age of 39.9 ± 19.8 years) or CSII without continuous glucose monitoring (n = 151, 35.7 ± 18.4 years). Primary effectiveness endpoints included change in A1C for Group 1 (baseline A1C >8.0%), from baseline to the end of study, and difference in the end of study percentage of time spent below 70 mg/dL (%TBR <70 mg/dL) for Group 2 (baseline A1C ≤8.0%), to show superiority of HCL intervention versus control. Secondary effectiveness endpoints were change in A1C and %TBR <70 mg/dL for Group 2 and Group 1, respectively, to show noninferiority of HCL intervention versus control. Primary safety endpoints were rates of severe hypoglycemia and diabetic ketoacidosis (DKA). Results: Change in A1C and difference in %TBR <70 mg/dL for the overall group were significantly improved, in favor of HCL intervention. In addition, a significant mean (95% confidence interval) change in A1C was observed for both Group 1 (-0.8% [-1.1% to -0.4%], P  < 0.0001) and Group 2 (-0.3% [-0.5% to -0.1%], P  < 0.0001), in favor of HCL intervention. The same was observed for difference in %TBR <70 mg/dL for Group 1 (-2.2% [-3.6% to -0.9%]) and Group 2 (-4.9% [-6.3% to -3.6%]) ( P  < 0.0001 for both). There was one DKA event during run-in and six severe hypoglycemic events: two during run-in and four during study (HCL: n = 0 and CSII: n = 4 [6.08 per 100 patient-years]). Conclusions: This RCT demonstrates that the MiniMed 670G HCL safely and significantly improved A1C and %TBR <70 mg/dL compared with CSII control in persons with T1D, irrespective of baseline A1C level.

Introduction: This trial assessed safety and effectiveness of an advanced hybrid closed-loop (AHCL) system with automated basal (Auto Basal) and automated bolus correction (Auto Correction) in adolescents and adults with type 1 diabetes (T1D). Materials and Methods: This multicenter single-arm study involved an intent-to-treat population of 157 individuals (39 adolescents aged 14-21 years and 118 adults aged ≥22-75 years) with T1D. Study participants used the MiniMed™ AHCL system during a baseline run-in period in which sensor-augmented pump +/- predictive low glucose management or Auto Basal was enabled for ∼14 days. Thereafter, Auto Basal and Auto Correction were enabled for a study phase (∼90 days), with glucose target set to 100 or 120 mg/dL for ∼45 days, followed by the other target for ∼45 days. Study endpoints included safety events and change in mean A1C, time in range (TIR, 70-180 mg/dL) and time below range (TBR, <70 mg/dL). Run-in and study phase values were compared using Wilcoxon signed-rank test or paired t -test. Results: Overall group time spent in closed loop averaged 94.9% ± 5.4% and involved only 1.2 ± 0.8 exits per week. Compared with run-in, AHCL reduced A1C from 7.5% ± 0.8% to 7.0% ± 0.5% (<0.001, Wilcoxon signed-rank test, n  = 155), TIR increased from 68.8% ± 10.5% to 74.5% ± 6.9% (<0.001, Wilcoxon signed-rank test), and TBR reduced from 3.3% ± 2.9% to 2.3% ± 1.7% (<0.001, Wilcoxon signed-rank test). Similar benefits to glycemia were observed for each age group and were more pronounced for the nighttime (12 AM-6 AM). The 100 mg/dL target increased TIR to 75.4% ( n  = 155), which was further optimized at a lower active insulin time (AIT) setting (i.e., 2 h), without increasing TBR. There were no severe hypoglycemic or diabetic ketoacidosis events during the study phase. Conclusions: These findings show that the MiniMed AHCL system is safe and allows for achievement of recommended glycemic targets in adolescents and adults with T1D. Adjustments in target and AIT settings may further optimize glycemia and improve user experience. Clinical Trial Registration number: NCT03959423.

A 3-month pivotal trial using the MiniMed™ 670G hybrid closed-loop (HCL) system in adolescent and adult patients with type 1 diabetes (T1D), relative to a 2-week baseline run-in period, resulted in increased sensor glucose (SG) values in target range (71-180 mg/dL), reduced HbA1c levels, and no events of diabetic ketoacidosis or severe hypoglycemia ( Clinicaltrials.gov : NCT02463097). This brief report evaluated how prior continuous glucose monitoring (CGM) experience influenced glycemic outcomes, in the same pivotal trial. HbA1c levels and the percentage of SG values in low, high, and in-target ranges were analyzed from participants (n = 124) completing the Hybrid Closed-Loop Pivotal Trial in T1D. There were 78 individuals comprising the prior CGM group and 46 comprising the no prior CGM group. Compared to baseline, HbA1c was reduced from 7.4% ± 0.9% to 6.9% ± 0.7% for the prior CGM group and from 7.5% ± 0.9% to 6.8% ± 0.5% for the no prior CGM group. For those with prior CGM experience, the mean percentage of in-target SG values increased from 66.9% ± 12.5% to 72.6% ± 9.1%, and for those with no prior CGM experience it increased from 66.6% ± 11.7% to 71.5% ± 8.5%. Similar improvement in glucose values in the low and high ranges, relative to baseline, was observed for both groups. Resulting outcomes, from baseline to study end, did not differ between each group. These findings suggest that individuals without prior CGM experience, and those already using CGM, will benefit similarly with use of the FDA-approved MiniMed 670G HCL system therapy.