Aim
To investigate real‐world glycaemic outcomes and goals achieved by users of the MiniMed 780G advanced hybrid closed loop (AHCL) system aged younger and older than 15 years with type 1 diabetes ...(T1D).
Materials and Methods
Data uploaded by MiniMed 780G system users from 27 August 2020 to 22 July 2021 were aggregated and retrospectively analysed based on self‐reported age (≤15 years and >15 years) for three cohorts: (a) post‐AHCL initiation, (b) 6‐month longitudinal post‐AHCL initiation and (c) pre‐ versus post‐AHCL initiation. Analyses included mean percentage of time spent in AHCL and at sensor glucose ranges, insulin delivered and the proportion of users achieving recommended glucose management indicator (GMI < 7.0%) and time in target range (TIR 70‐180 mg/dl > 70%) goals.
Results
Users aged 15 years or younger (N = 3211) achieved a GMI of 6.8% ± 0.3% and TIR of 73.9% ± 8.7%, while spending 92.7% of time in AHCL. Users aged older than 15 years (N = 8874) achieved a GMI of 6.8% ± 0.4% and TIR of 76.5% ± 9.4% with 92.3% of time in AHCL. Time spent at less than 70 mg/dl was within the recommended target of less than 4% (3.2% and 2.3%, respectively). Similar outcomes were observed for each group (N = 790 and N = 1642, respectively) in the first month following AHCL initiation, and were sustained over the 6‐month observation period.
Conclusions
This real‐world analysis shows that more than 75% of users with T1D aged 15 years or younger using the MiniMed 780G system achieved international consensus‐recommended glycaemic control, mirroring the achievements of the population aged older than 15 years.
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.
Real-world data from the first 3141 patients who completed 3 months of SmartGuard™ Auto Mode-enabled MiniMed™ 670G system use during the MiniMed 670G System Commercial Launch are reported. CareLink™ ...system data uploaded by real-world patients in the Commercial Launch from March 17, 2017 to December 31, 2017 were deidentified and analyzed. Comparisons of overall and night (10:00 PM-07:00 AM) time spent below, within, and above target glucose range (TIR) (70-180 mg/dL) between the baseline Manual Mode and closed-loop Auto Mode periods were made. These were evaluated alongside data from the 124 patients (aged 14-75 years) who completed the 3-month MiniMed 670G system pivotal trial (NCT 2463097), from June 2, 2015 to March 7, 2016. Real-world patients used Auto Mode a median 80.8% of the time (19 h and 24 min of the day). The overall mean of time spent in TIR was 66.0% during baseline Manual Mode versus 73.3% during Auto Mode (P < 0.001); the mean percentage of sensor glucose values <70 mg/dL was 2.7% versus 2.1% (P < 0.001); and that >180 mg/dL was 31.4% versus 24.6% (P < 0.001). The nighttime and early morning (03:00 AM-06:00 AM) TIR during Auto Mode was greater than that during baseline Manual Mode (nighttime: 77.2% vs. 67.4% P < 0.001, early morning: 70.9% vs. 84.6% P < 0.001). Similar differences between Manual Mode and Auto Mode TIR were observed across different age groups. A slight increase in total insulin delivered was also observed. Consistent with improved glycemic control demonstrated in the pivotal trial, analysis of CareLink system data from >3000 real-world patients who completed 3 months of Auto Mode-enabled MiniMed 670G system use demonstrated increased TIR and decreased time below and above TIR compared with baseline. These improved clinical outcomes were observed across a broad age range of patients with type 1 diabetes.
Objective: To evaluate real-world glycemic outcomes and insulin delivery based on TIR (70-180mg/dL) before and after MiniMed™ 780G system use by children with T1D.
Methods: MiniMed™ 780G system data ...from 2,516 users aged ≤15 years (from Europe, the Middle East and Africa) who provided assent, were uploaded between Aug 2020 and Jun 2022. For users with ≥10 days of sensor glucose (SG) data, glycemic outcomes (e.g., SG, time in SG ranges and glucose management indicator GMI), insulin delivered, and use of the 100mg/dL* glucose target and 2hrs active insulin time (recommended settings) were summarized and stratified by baseline TIR quartiles. Results: After AHCL initiation, overall glycemic control (GMI) improved and TIR increased in all TIR quartiles, with increased system-initiated insulin (auto basal and auto correction) delivery and fewer user-initiated boluses (Figure). Greater recommended settings use was associated with a higher TIR (4th quartile) and less recommended settings use was associated with a lower TIR (1st quartile).
Conclusion: Children with T1D using the MiniMed™ 780G system had improved glycemic control evidenced by increased TIR with less effort (i.e., fewer user-initiated boluses). Glycemic control was improved across the spectrum of users and use of recommended settings enhanced outcomes.
Disclosure
J.Mcvean: Employee; Medtronic. A.Arrieta: Employee; Medtronic. T.L.Cordero: Employee; Medtronic. J.Castañeda: Employee; Medtronic. O.Cohen: Employee; Medtronic.
Objective: The present study evaluated real-world pediatric glycemia during use of MiniMed™ 780G recommended settings (100 mg/dL* glucose target GT and 2hrs active insulin time AIT).
Methods: Overall ...mean TIR, after AHCL initiation, in the pediatric pivotal trial (ages 7-17 years) was 70.3% (N=160).1 For participants using recommended settings >95% of the time, mean TIR was 73.4% (N=19). In this abstract, we present real-world glycemic outcomes in children (≤15 years) from multiple continents using a range of GT and AIT settings, versus the recommended GT and AIT settings. Assented real-world users with ≥10 days of sensor glucose (SG) data from EMEA (N=3,211 in Europe, the Middle East, and Africa) and Latin America (N=332) uploaded system data between Aug 2020-Sep 2022. Outcomes included the mean of SG, glucose management indicator and percentage of time spent below, within and above target (70-180 mg/dL) range.
Results: Real-world outcomes from children in EMEA and Latin America using overall AHCL settings met consensus goals (Figure)2 and TIR increased further when recommended settings were used.
Conclusion: Findings in a population of children from around the world with T1D who used MiniMed™ 780G AHCL at recommended settings (versus a range of settings) had the highest time in range, without compromising time below range.
Disclosure
J.Mcvean: Employee; Medtronic. A.Arrieta: Employee; Medtronic. T.L.Cordero: Employee; Medtronic. M.Castro: Employee; Medtronic. J.Castañeda: Employee; Medtronic. O.Cohen: Employee; Medtronic.
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.
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.
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 (
< 0.001) and from 19 ± 7 days to 15 ± 15 days (
< 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.
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.
Aim
To evaluate the real‐world performance of the MiniMed 670G system in Europe, in individuals with diabetes.
Materials and Methods
Data uploaded from October 2018 to July 2020 by individuals living ...in Europe were aggregated and retrospectively analysed. The mean glucose management indicator (GMI), percentage of time spent within (TIR), below (TBR) and above (TAR) glycaemic ranges, system use and insulin consumed in users with 10 or more days of sensor glucose data after initial Auto Mode start were determined. Another analysis based on suboptimally (GMI > 8.0%) and well‐controlled (GMI < 7.0%) glycaemia pre‐Auto Mode initiation was also performed.
Results
Users (N = 14 899) spent a mean of 81.4% of the time in Auto Mode and achieved a mean GMI of 7.0% ± 0.4%, TIR of 72.0% ± 9.7%, TBR less than 3.9 mmol/L of 2.4% ± 2.1% and TAR more than 10 mmol/L of 25.7% ± 10%, after initiating Auto Mode. When compared with pre‐Auto Mode initiation, GMI was reduced by 0.3% ± 0.4% and TIR increased by 9.6% ± 9.9% (P < .0001 for both). Significantly improved glycaemic control was observed irrespective of pre‐Auto Mode GMI levels of less than 7.0% or of more than 8.0%. While the total daily dose of insulin increased for both groups, a greater increase was observed in the latter, an increase primarily due to increased basal insulin delivery. By contrast, basal insulin decreased slightly in well‐controlled users.
Conclusions
Most MiniMed 670G system users in Europe achieved TIR more than 70% and GMI less than 7% while minimizing hypoglycaemia, in a real‐world environment. These international consensus‐met outcomes were enabled by automated insulin delivery meeting real‐time insulin requirements adapted to each individual user.
The safety and effectiveness of the in-home use of a hybrid closed-loop (HCL) system that automatically increases, decreases, and suspends insulin delivery in response to continuous glucose ...monitoring were investigated.
Adolescents (n = 30, ages 14-21 years) and adults (n = 94, ages 22-75 years) with type 1 diabetes participated in a multicenter (nine sites in the United States, one site in Israel) pivotal trial. The Medtronic MiniMed
670G system was used during a 2-week run-in phase without HCL control, or Auto Mode, enabled (Manual Mode) and, thereafter, with Auto Mode enabled during a 3-month study phase. A supervised hotel stay (6 days/5 nights) that included a 24-h frequent blood sample testing with a reference measurement (i-STAT) occurred during the study phase.
Adolescents (mean ± standard deviation SD 16.5 ± 2.29 years of age and 7.7 ± 4.15 years of diabetes) used the system for a median 75.8% (interquartile range IQR 68.0%-88.4%) of the time (2977 patient-days). Adults (mean ± SD 44.6 ± 12.79 years of age and 26.4 ± 12.43 years of diabetes) used the system for a median 88.0% (IQR 77.6%-92.7%) of the time (9412 patient-days). From baseline run-in to the end of study phase, adolescent and adult HbA
levels decreased from 7.7% ± 0.8% to 7.1% ± 0.6% (P < 0.001) and from 7.3% ± 0.9% to 6.8% ± 0.6% (P < 0.001, Wilcoxon signed-rank test), respectively. The proportion of overall in-target (71-180 mg/dL) sensor glucose (SG) values increased from 60.4% ± 10.9% to 67.2% ± 8.2% (P < 0.001) in adolescents and from 68.8% ± 11.9% to 73.8% ± 8.4% (P < 0.001) in adults. During the hotel stay, the proportion of in-target i-STAT
blood glucose values was 67.4% ± 27.7% compared to SG values of 72.0% ± 11.6% for adolescents and 74.2% ± 17.5% compared to 76.9% ± 8.3% for adults. There were no severe hypoglycemic or diabetic ketoacidosis events in either cohort.
HCL therapy was safe during in-home use by adolescents and adults and the study phase demonstrated increased time in target, and reductions in HbA
hyperglycemia and hypoglycemia, compared to baseline.
Clinicaltrials.gov identifier: NCT02463097.
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).
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
-test.
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,
= 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% (
= 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.
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.
Aims
The effects of continuous subcutaneous insulin infusion (CSII) therapy with or without continuous glucose monitoring (CGM) on neonatal outcomes and glycemic outcomes of pregnant women with type ...1 diabetes (T1D), living in Poland, were assessed.
Methods
This prospective observational study enrolled women with
T
1D (
N
= 481, aged 18–45 years) who were pregnant or planned pregnancy. All used CSII therapy and a subset used CGM with CSII (CSII + CGM). Neonatal outcomes (e.g., rate of large for gestational age LGA delivery birth weight > 90th percentile) and maternal glycemia (e.g., HbA1c and percentage of time at sensor glucose ranges) were evaluated.
Results
Overall HbA1c at trimesters 1, 2, and 3 was 6.8 ± 1.1% (50.9 ± 12.3 mmol/mol,
N
= 354), 5.8 ± 0.7% (40.1 ± 8.0 mmol/mol,
N
= 318), and 5.9 ± 0.7% (41.4 ± 8.0 mmol/mol,
N
= 255), respectively. A HbA1c target of < 6.0% (42 mmol/mol) at each trimester was achieved by 20.9% (74/354), 65.1% (207/318), and 58.0% (148/255), respectively. For women using CSII + CGM versus CSII only, HbA1c levels at trimesters 1, 2, and 3 were 6.5 ± 0.9% versus 7.1 ± 1.3% (47.8 ± 9.7 mmol/mol versus 54.3 ± 14.0 mmol/mol,
p
< 0.0001), 5.7 ± 0.6% versus 6.0 ± 0.9% (38.9 ± 6.5 mmol/mol versus 41.6 ± 9.3 mmol/mol,
p
= 0.0122), and 5.8 ± 0.6% versus 6.1 ± 0.8% (40.3 ± 6.9 mmol/mol versus 42.9 ± 9.1 mmol/mol,
p
= 0.0117), respectively. For the overall, CSII only, and CSII + CGM groups, rates of LGA delivery were 22.7% (74/326), 24.6% (34/138), and 21.3% (40/188), respectively.
Conclusions
Observational assessment of women with
T
1D using CSII therapy demonstrated low HbA1c throughout pregnancy and low rates of LGA. The addition of CGM to CSII therapy compared to CSII therapy alone was associated with some improved maternal glycemic and neonatal outcomes.
Clinicaltrials.gov identifier
NCT01779141 (January 2013).
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