12-Month Efficacy of Advanced Hybrid Closed-Loop System in Adult Type 1 Diabetes Patients

Abstract

Automated insulin delivery (AID) systems have improved glycemic control in individuals with type 1 diabetes (T1D). The “advanced hybrid closed loop” (AHCL) stands out as the most recent development in AID systems for T1D management. In a real-world clinical environment, we retrospectively evaluated the AHCL MiniMed™ 780G system's effectiveness to achieve and sustain glycemic control over a 12-month period in 22 adult T1D subjects. Within just 14 days of activating the automatic mode, the AHCL MiniMed 780G system showed rapid improvement in glycemic control, which persisted for 12 months. These findings underscore the effectiveness of AHCL systems in achieving and preserving optimal glycemic control in adults with T1D over a very long follow-up.

Introduction

In recent years, we have witnessed a major advancement in technology applied to diabetes management. Automated insulin delivery (AID) systems have greatly enhanced glycemic control in patients with type 1 diabetes (T1D), concurrently reducing the risk of hypoglycemia.^1
–3 To date, “advanced hybrid closed loop” (AHCL) systems are at the forefront of this technological progression for T1D treatment.^4,5 These systems, integrating an insulin pump with a continuous glucose monitoring (CGM) system, automatically adjust basal insulin infusion based on real-time glucose monitoring, and also manage corrective bolus administration.

The MiniMed™ 780G (developed by Medtronic in Northridge, CA) is an AHCL system. It operates on an algorithm that administers automated basal insulin with customizable targets for sensor glucose levels set at 100, 110, 120 mg/dL (for instances such as physical activity, a temporary target of 150 mg/dL can also be configured), as well as correction boluses every 5 min. In addition, the system allows users to set a variable active insulin time (AIT), ranging from 2 to 8 h, offering flexibility in the algorithm's response speed. The MiniMed 780G can function as a predictive low glucose suspend (PLGS) system. This mode provides a user-programmed insulin delivery, with automated suspension of insulin distribution as the system foresees impending hypoglycemia.

This is often referred to as the “manual mode.” It is the default setting when the system is first initiated and can be maintained for an adjustable time duration before transitioning to the “automated mode” (“SmartGuard function”).⁶ The glycemic data from the MiniMed 780G can be transferred to the CareLink platform, either manually or via the MiniMed CareLink App. Past clinical trials and real-world studies on the MiniMed 780G, many of which involving T1D patients, previous users of insulin pumps or CGM systems of varying automation,^{7

–16} have demonstrated its safety and efficacy.

These studies have shown that the system meets the consensus-based glycemic targets (GTs) regarding standardized CGM measures for clinical care.¹⁷ These include the glucose management indicator (GMI, targeted to be ≤7%), time in range (TIR, set between 70 and 180 mg/dL and aimed to be >70%), time below range (TBR, aiming for <70 mg/dL, and targeted to be <4% and 1% when considering values <54 mg/dL), time above range (TAR, exceeding 180 mg/dL, which should be <25% and <5% for values >250 mg/dL), and glycemic variability (expressed as coefficient of variation [CV], targeted to be ≤36%) in both young and adult T1D patients.

Furthermore, the recent Advanced Hybrid Closed Loop Study in the Adult Population with T1D examined the efficiency of the AHCL MiniMed 780G system in adult T1D patients in poor glycemic control (with glycated hemoglobin at least 8%). These patients were on standard treatments (multiple daily insulin injections [MDI] associated with intermittent or real-time CGM) for a 6-month period. The findings revealed that the AHCL system offered substantial advantages in glycemic management over MDI combined with CGM.¹⁸ Up until now, there have been very few studies with a long observational period, extending beyond 6 months. The aim of the present study was to evaluate the efficacy of the MiniMed 780G system over a 12-month period in achieving and sustaining glycemic control among adult T1D patients in a real-world clinical environment. In addition, we explored clinical parameters that might correlate with glycemic outcomes.

Materials and Methods

We conducted a retrospective, observational, single-center, real-world study involving patients from the Diabetes and Metabolic Diseases Unit of the University of Siena. This study focused on adult patients with T1D who were introduced to the MiniMed 780G system. We thoroughly reviewed clinical data, device data, and CareLink reports from the 12 months following the introduction of the AHCL system. All individuals involved in the study gave their written consent for their data to be utilized. The local research ethics committee granted approval for the study, which adhered to the standards set by the Declaration of Helsinki, as updated in 2013. We enrolled a total of 22 T1D patients (9 males, 13 females), all of whom were aged 18 or older.

Before the introduction of the MiniMed 780G system (at baseline, referred to as T0), we assessed several parameters: age, duration of diabetes, prior insulin treatment, glycated hemoglobin (HbA1c), total daily insulin (TDI) dose, and body mass index (BMI). Following the initiation of the AHCL system, we examined various metrics at specific time points: 14 days post initiation of the manual mode (labeled as M, during which period the MiniMed 780G functioned as a PLGS system) and 14 days after transitioning to the automated mode (designated as A, or auto-mode). Additional time points occurred 14 days post 3 months (A3M), 6 months (A6M), and 12 months (A12M) within the auto-mode. We then compared the data from these auto-mode time settings (A, A3M, A6M, A12M) with that of the manual mode (M).

The specific metrics we assessed included the following: TIR, TAR (subdivided further into TAR >180 mg/dL and TAR >250 mg/dL—labeled as TAR250), TBR (further categorized into TBR <70 mg/dL and TBR <54 mg/dL—denoted as TBR54), CV, HbA1c, GMI, mean glucose (GM), and TDI. In addition, we sought to discern potential correlations between the aforementioned glycemic outcomes at the A and A12M time points and the baseline metrics (such as HbA1c, TDI, age, duration of diabetes, BMI) in conjunction with the average duration of AHCL use during the manual mode (M). We also categorized the study participants based on several criteria to identify any distinct patterns among different groups. These subdivisions were as follows: gender (comparing males and females), glycemic control at baseline (patients with HbA1c >7% vs. patients with HbA1c ≤7%), and duration of diabetes (≥25 years vs. <25 years).

Furthermore, based on specific device settings at 12 months, we subdivided patients as follows: AIT (<2 h and 30 min and ≥2 h and 30 min) and GT (<120 and 120 mg/dL). We recorded the occurrence of diabetic ketoacidosis or episodes of severe hypoglycemia. Finally, to strengthen our results, we analyzed CGM parameters over a 30-day period (instead of a 14-day period), at the same time points (M, A, A3M, A6M, 12AM). This extended analysis was performed on a subset of participants (n = 11) who used the manual mode for at least of 30 days.

The continuous variables examined were represented as mean and standard deviation. All statistical evaluations were performed using the GraphPad software, version 8.2.1 (441). Depending on the results from normality and log normality tests, we utilized either the paired t-test or the Wilcoxon signed-rank test to analyze the data. To discern differences between distinct groups, we used the nonparametric Mann–Whitney U test. For establishing correlations between continuous variables, we used the nonparametric Spearman test. A P-value <0.05 was considered statistically significant.

Results

At baseline (T0), the participants exhibited the following average characteristics: age 43.95 ± 12.22 years, duration of diabetes 27.18 ± 12.98 years, glycated hemoglobin (HbA1c) 7.35 ± 0.81% (10 patients had HbA1c ≤7%), TDI dose 36.67 ± 12.98 units, and BMI 24.75 ± 3.26 kg/m². Regarding their prior treatments, 5 patients were on MDI, 11 patients were using a non-Automated Insulin Pump system (nAID), which combined an insulin pump with either a CGM system or a flash glucose monitoring sensor, 2 patients utilized a PLGS system, and 4 patients were on a hybrid closed-loop (HCL) system, with automatic basal insulin infusion but without corrective bolus delivery.

In terms of complications related to diabetes, 3 patients were diagnosed with diabetic retinopathy, 2 had diabetic neuropathy, 2 were suffering from diabetic nephropathy, and 6 individuals presented with macrovascular complications (which included 1 with peripheral arteriopathy, 1 with ischemic cardiopathy, and 4 with carotid arteriopathy). All these baseline characteristics of the study participants are summarized in Table 1. During the 12-month observation period, no episodes of ketoacidosis or severe hypoglycemia were recorded. All participants consistently had a >70% use of CGM throughout the study.

Table 1.

Baseline Characteristics of the Study Population

Subjects (M/F)	22 (9/13)
Age (years)	43.95 ± 12.22
Diabetes duration (years)	27.18 ± 12.98
Body mass index (kg/m²)	24.75 ± 3.26
Previous insulin therapy	5 multiple daily injections insulin therapy, 11 not automated insulin delivery system, 2 sensor-augmented pump with predictive low-glucose suspension, 4 hybrid closed-loop system
HbA1c (%)	7.35 ± 0.81
Subjects with HbA1c ≤7%	10
Mean daily insulin dose (UI)	36.67 ± 12.98
Diabetic chronic complications
Diabetic retinopathy (n subjects)	3
Diabetic neuropathy (n subjects)	2
Diabetic nephropathy (n subjects)	2
Carotid arterial disease (n subjects)	4
Peripheral arterial disease (n subjects)	1
Ischemic heart disease (n subjects)	1

By the end of the observation period (A12M), 10 patients had set their GT to 120 mg/dL, 7 patients to 110 mg/dL, 5 patients to 100 mg/dL, 5 patients had set their AIT to 3 h, 2 patients to 2 h 45 min, 7 patients to 2 h 30 min, and 8 patients to 2 h. The average duration of the manual mode (M) was 46.77 ± 37.46 days, with notable variability across the 22 subjects. All participants demonstrated a consistently high usage percentage (%) of the SmartGuard function, remaining stable throughout their time in auto-mode (% SmartGuard A: 96 ± 0.15%; % SmartGuard A3M: 94 ± 0.02%; % SmartGuard A6M: 96 ± 0.08%; % SmartGuard A12M: 97 ± 0.042%). Remarkably, just 14 days after switching from manual mode (M) to auto-mode (A), there were significant improvements in the CGM metrics.

Specifically, a significant reduction in TAR% (P: 0.0002), TBR% (P: 0.013), CV% (P: 0.0021), mean glucose (GM) (mg/dL; P: 0.0001), and GMI% (P: 0.0156) and a significant increase in TIR% (P < 0.00001) were observed (Fig. 1). These outcomes, regarding TIR%, TAR%, CV%, GMI%, and GM, were sustained and evident at subsequent time points, namely A3M, A6M, and A12M, in comparison with the initial manual mode (M) (Fig. 1). In addition, at A12M, we observed a significant reduction in HbA1c% (P: 0.0001) compared with the baseline T0 (HbA1c 6.82 ± 0.84% at A12M vs. 7.35 ± 0.81% at T0, Fig. 1) and 14 patients had achieved a target HbA1c ≤7%. Just 14 days into the auto-mode (A), patients had already met the target metrics based on standardized CGM criteria for clinical care.

FIG. 1.

Results at different time points. (a) Time in range% A, A3M, A6M, A12M versus M; (b) time above range% AM, 3AM, 6AM, 12AM versus M; (c) time below range% A, A3M, A6M, A12M versus M; (d) glucose management indicator% A, A3M, A6M, A12M versus M; (e) coefficient of variation% A, A3M, A6M, A12M versus M; (f) mean glucose A, A3M, A6M, A12M versus M; (g) glycated hemoglobin% A12M versus M. A, first 14 days auto-mode; A12M, 14 days after 12 months auto-mode; A3M, 14 days after 3 months auto-mode; A6M, 14 days after 6 months auto-mode; M, manual mode.

In detail, TIR 78 ± 0.07%, and 19 patients with desired TIR of ≥70%, TAR 21 ± 0.07%, with 13 patients meeting TAR ≤25%, TBR 2 ± 0.01% with 0% values below 54 mg/dL and 20 patients with TBR of ≤4%, GMI 6.81 ± 0.27% and 17 patients with GMI of ≤7%, and CV 30.39 ± 3.98%, and 21 patients with CV ≤36%. These commendable metrics were sustained throughout the 12-month follow-up. By the end of the observational period (A12M), the values recorded were as follows: TIR 80 ± 0.94%, with 18 patients to target, TAR 18 ± 0.09%, with 13 patients to target, TBR: 2 ± 0.01% with 0% values <54 mg/dL, and 19 patients to target, GMI 6.68 ± 0.41% with 19 patients to target, CV 29.09 ± 4.67%, with 20 patients to target.

Interestingly, there was no notable difference in TDI at the end of follow-up (A12M) in comparison with both the initial T0 and the manual mode (M). The average BMI remained consistent over the 12-month period when compared with baseline (T0). When we delved into potential correlations between the glycemic outcomes at A and at A12M and baseline parameters such as age, HbA1c, TDI, BMI, and the duration of diabetes (T0), several interesting associations emerged: A12M TIR% was found to have a negative correlation with both baseline HbA1c% (P: 0.0113) and HbA1c% at A12M (P: 0.0099), A12M TAR% had a positive correlation with HbA1c% at both T0 and A12M (with P-values 0.0133 and 0.0148, respectively). The HbA1c% at A12M showed a strong positive correlation with the baseline HbA1c% (P < 0.0001).

Furthermore, the GMI% at A12M positively correlated with HbA1c% at T0 (P: 0.0068). It is worth noting that there was no discernible correlation between glycemic outcomes at A, A3M, A6M, and A12M and the average time patients spent in the manual mode (M). When the study population was subdivided based on gender, duration of diabetes (≥25 years vs. <25 years), and the state of glycemic control at baseline (HbA1c >7% vs. ≤7%), there were no statistically significant differences observed between these groups. Upon subdividing patients at A12M based on their AIT (<2 h 30 min and ≥2 h 30 min), as well as their GT (<120 and 120 mg/dL), it was observed that there were no statistically significant differences between these subgroups.

The sole exception was for patients who had set their GT <120 mg/dL; they displayed a notably lower GMI% when compared with those with a GT 120 mg/dL (P: 0.0499). In a further analysis of a subset of patients (n = 11), by evaluating CGM parameters over a 30-day period at similar time points, the outcomes essentially mirrored those obtained from the initial 14-day analysis. Specifically, 30 days after transitioning from manual mode (M) to auto-mode (A), there was a notable reduction in TAR% (P: 0.0008), TBR% (P: 0.0162), CV% (P: 0.0434), GM (mg/dL; P: 0.0033), and GMI% (P: 0.0232), and a significant increase in TIR% (P: 0.0003). In addition, there was a meaningful reduction in TAR250% (P: 0.0195).

These findings were consistently evident at A3M, A6M, and A12M when compared with the initial manual mode (M). However, TBR% and CV% did not reach a statistical significance (at A3M, A6M, and A12M for TBR%, and at A6M and A12M for CV%, respectively).

Discussion

Over a 12-month period in a real-world clinical environment, we demonstrated the effectiveness of the AHCL MiniMed 780G system in managing glycemic control in adult T1D patients. At the end of follow-up, there was a marked and statistically significant decrease in HbA1c% in comparison with the baseline. Most of the participants achieved an HbA1c% < 7% and consensus-based GTs regarding standardized CGM metrics derived from the CareLink reports, such as TIR%, TAR%, TBR%, CV%, GMI%, and mean glucose. Notably, these positive outcomes in glycemic control became evident just 14 days post the initiation of the auto-mode and maintained consistency throughout the subsequent months. This showcases the system's rapid and enduring effectiveness, observed by other authors as well.^{9,11,14,19

–24}

Furthermore, these findings at the beginning of the auto-mode and at 12 months appeared to be unaffected by gender, age, duration of diabetes, BMI, and TDI at baseline. It is also worth noting that there was no difference in outcomes between patients with an HbA1c ≥7% and those with an HbA1c <7% at baseline. Our study not only reinforces existing findings regarding the efficacy of AHCL systems in achieving optimal glycemic control, but also demonstrates the ability to maintain it over a period; of note a 12-month follow-up represents a very long observational period. In our opinion, it represents the main strength of our study as there are very few data about the effectiveness of the MiniMed 780G system at 12 months in both children/adolescents and adults.^19,20,25

One significant observation is the prompt attainment of a good glycemic control (achieved in just 14 days of auto-mode), observed by other authors also,^14,22
–24 achieved irrespective of the manual mode duration. Several other observations underscore the inherent efficacy of the MiniMed 780G system: for instance, a substantial portion of the study participants had already achieved their target HbA1c% at baseline, which inherently makes further improvements a challenge without raising the risk of hypoglycemia; in addition, many participants were prior users of either the PLGS or HCL systems. Our 12-month findings seemingly indicate that outcomes were not swayed by variables such as AIT or GT, apart from a lower GMI% at A12M in patients with GT <120 mg/dL compared with those with a GT 120 mg/dL.

Nevertheless, the limited sample size could challenge the validity of these findings. For instance, Castañeda et al. identified an association between a 2-h AIT and 100 mg/dL GT with a higher TIR%, in a considerably larger cohort of MiniMed 780G users.²⁶ Our study's small population size, however, rather than being a limitation, should be seen in a positive light, emphasizing the robustness and consistency of the results obtained with AHCL systems in much larger cohorts. In addition, by juxtaposing our findings with outcomes from other 12-month real-world studies,^{16,20,24,25,27} we get further affirmation about the safety, efficacy, and long-lasting glycemic control of the MiniMed 780G system. Notably, the transition to the automated mode did not increase the occurrence of hypoglycemia.

Even in many trials, as well as in the present study, there was a noticeable decrease in TBR%. Furthermore, all these outcomes appear to be consistent in children, adolescents, and adults, and the effectiveness of the AHCL system remains evident regardless of the preceding insulin therapy (MDI with or without CGM, nAID, PLGS, or HCL). While it is important to point out that details of previous insulin treatments might not always be thoroughly documented and could differ among participants within the same study (as in ours), the overarching benefits of the AHCL system remain reliable.

Conclusions

In conclusion, this retrospective real-world study underscores the rapid and enduring improvement of glycemic control obtained by the AHCL MiniMed 780G system in adult T1D patients. Not only does the system facilitate the achievement of GTs but it also ensures their consistent maintenance over a 12-month period.

Footnotes

Acknowledgments

The authors would like to thank all the study participants.

Authors' Contributions

L.N.: conceptualization, formal analysis, and writing—original draft; G.I.S.: data curation and writing—original draft; D.C.: data curation; F.D.: writing—review and editing and supervision.

Authors Disclosure Statement

No competing financial interests exist.

Funding Information

No funding was received for this article.

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