The changing landscape of automated insulin delivery in the management of type 1 diabetes.
Ontology highlight
ABSTRACT:
SUBMITTER: Lakshman R
PROVIDER: S-EPMC10448576 | biostudies-literature | 2023 Jul
REPOSITORIES: biostudies-literature
Publications
The changing landscape of automated insulin delivery in the management of type 1 diabetes.
Lakshman Rama R Boughton Charlotte C Hovorka Roman R
Endocrine connections 20230731 8
Automated insulin delivery systems, also known as closed-loop or 'artificial pancreas' systems, are transforming the management of type 1 diabetes. These systems consist of an algorithm which responds to real-time glucose sensor levels by automatically modulating insulin delivery through an insulin pump. We review the rapidly changing landscape of automated insulin-delivery systems over recent decades, from initial prototypes to the different hybrid closed-loop systems commercially available tod ...[more]
Similar Datasets
Project description:BackgroundAutomated insulin delivery (AID) systems have shown to improve glycemic control in a range of populations and settings. At the start of this study, only one commercial AID system had entered the Austrian market (MiniMed 670G, Medtronic). However, there is an ever-growing community of people living with type 1 diabetes (PWT1D) using open-source (OS) AID systems.Materials and methodsA total of 144 PWT1D who used either the MiniMed 670G (670G) or OS-AID systems routinely for a period of at least three to a maximum of six months, between February 18, 2020 and January 15, 2023, were retrospectively analyzed (116 670G aged from 2.6 to 71.8 years and 28 OS-AID aged from 3.4 to 53.5 years). The goal is to evaluate and compare the quality of glycemic control of commercially available AID and OS-AID systems and to present all data by an in-depth descriptive analysis of the population. No statistical tests were performed.ResultsThe PWT1D using OS-AID systems spent more time in range (TIR)70-180 mg/dL (81.7% vs 73.9%), less time above range (TAR)181-250 mg/dL (11.1% vs 19.6%), less TAR>250 mg/dL (2.5% vs 4.3%), and more time below range (TBR)54-69 mg/dL (2.2% vs 1.7%) than PWT1D using the 670G system. The TBR<54 mg/dL was comparable in both groups (0.3% vs 0.4%). In the OS-AID group, median glucose level and glycated hemoglobin (HbA1c) were lower than in the 670G system group (130 vs 150 mg/dL; 6.2% vs 7.0%).ConclusionIn conclusion, both groups were able to achieve satisfactory glycemic outcomes independent of age, gender, and diabetes duration. However, the PWT1D using OS-AID systems attained an even better glycemic control with no clinical safety concerns.
| S-EPMC11571566 | biostudies-literature
Project description:Background: Use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) as adjunct therapy to insulin in type 1 diabetes (T1D) has been previously studied. In this study, we present data from the first free-living trial combining low-dose SGLT2i with commercial automated insulin delivery (AID) or predictive low glucose suspend (PLGS) systems. Methods: In an 8-week, randomized, controlled crossover trial, adults with T1D received 5 mg/day empagliflozin (EMPA) or no drug (NOEMPA) as adjunct to insulin therapy. Participants were also randomized to sequential orders of AID (Control-IQ) and PLGS (Basal-IQ) systems for 4 and 2 weeks, respectively. The primary endpoint was percent time-in-range (TIR) 70-180 mg/dL during daytime (7:00-23:00 h) while on AID (NCT04201496). Findings: A total of 39 subjects were enrolled, 35 were randomized, 34 (EMPA; n = 18 and NOEMPA n = 16) were analyzed according to the intention-to-treat principle, and 32 (EMPA; n = 16 and NOEMPA n = 16) completed the trial. On AID, EMPA versus NOEMPA had higher daytime TIR 81% versus 71% with a mean estimated difference of +9.9% (confidence interval [95% CI] 0.6-19.1); p = 0.04. On PLGS, the EMPA versus NOEMPA daytime TIR was 80% versus 63%, mean estimated difference of +16.5% (95% CI 7.3-25.7); p < 0.001. One subject on SGLT2i and AID had one episode of diabetic ketoacidosis with nonfunctioning insulin pump infusion site occlusion contributory. Interpretation: In an 8-week outpatient study, addition of 5 mg daily empagliflozin to commercially available AID or PLGS systems significantly improved daytime glucose control in individuals with T1D, without increased hypoglycemia risk. However, the risk of ketosis and ketoacidosis remains. Therefore, future studies with SGLT2i will need modifications to closed-loop control algorithms to enhance safety.
| S-EPMC9464084 | biostudies-literature
Project description:ImportanceThere is a need for additional treatment options for people with type 2 diabetes treated with insulin. Given the limited data on the use of automated insulin delivery (AID) systems in type 2 diabetes, studies evaluating their safety and efficacy are important.ObjectiveTo evaluate the association of AID with hemoglobin A1c (HbA1c) levels in a diverse cohort of adults with type 2 diabetes.Design, setting, and participantsThis single-arm prospective trial was conducted at 21 clinical centers in the United States among individuals aged 18 to 75 years with type 2 diabetes who had been using insulin for at least 3 months prior to screening. Participants with AID system use were excluded. The study started with a 14-day standard therapy phase, followed by 13 weeks of treatment with the investigational device. The first participant was enrolled April 11, 2023, and the last participant follow-up visit was February 29, 2024.InterventionParticipants used the Omnipod 5 AID System for 13 weeks following the 14-day standard therapy phase.Main outcomes and measuresPrimary outcome was change in HbA1c level at 13 weeks, tested sequentially for noninferiority (0.3% margin) and superiority, compared with baseline.ResultsAmong 305 participants (mean [SD] age, 57 [11] years; 175 [57%] female; 72 [24%] Black, 66 [22%] Hispanic or Latino, and 153 [50%] White), 289 (95%) completed the trial. At baseline, 223 (73%) were using multiple daily injections, 63 (21%) were using basal insulin without bolus, 17 (6%) were using an insulin pump, 188 (62%) were using continuous glucose monitoring, 168 (55%) were using glucagon-like peptide-1 receptor agonists (GLP-1RAs), and 134 (44%) were using sodium-glucose transport protein 2 inhibitors (SGLT-2is). Following AID use, HbA1c levels decreased from a mean (SD) of 8.2% (1.3) at baseline to 7.4% (0.9) at 13 weeks (mean difference, -0.8 [95% CI, -1.0 to -0.7] percentage points; P < .001 for noninferiority and superiority). Improvement was seen across various subgroups (age, sex, race and ethnicity, insurance), and notably with or without use of GLP-1RAs or SGLT-2is and regardless of pretrial mealtime insulin regimen. Time in target glucose range (70-180 mg/dL) increased from a mean (SD) of 45% (25) to 66% (17) (mean difference, 20 [95% CI, 18 to 22] percentage points; P < .001). Percentage of time in hypoglycemic ranges of less than 54 mg/dL and less than 70 mg/dL was noninferior compared with standard therapy. There was 1 episode of severe hypoglycemia and none of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.Conclusions and relevanceIn this nonrandomized clinical trial, HbA1c levels were lower in a diverse cohort of adults with type 2 diabetes following AID initiation, suggesting that AID may be a beneficial and safe option for people with type 2 diabetes using insulin.Trial registrationClinicalTrials.gov Identifier: NCT05815342.
| S-EPMC11829226 | biostudies-literature
Project description:Type 1 diabetes (T1D) increases the risk for pregnancy complications. Increased time in the pregnancy glucose target range (63-140 mg/dL as suggested by clinical guidelines) is associated with improved pregnancy outcomes that underscores the need for tight glycemic control. While closed-loop control is highly effective in regulating blood glucose levels in individuals with T1D, its use during pregnancy requires adjustments to meet the tight glycemic control and changing insulin requirements with advancing gestation. In this paper, we tailor a zone model predictive controller (zone-MPC), an optimization-based control strategy that uses model predictions, for use during pregnancy and verify its robustness in-silico through a broad range of scenarios. We customize the existing zone-MPC to satisfy pregnancy-specific glucose control objectives by having (i) lower target glycemic zones (i.e., 80-110 mg/dL daytime and 80-100 mg/dL overnight), (ii) more assertive correction bolus for hyperglycemia, and (iii) a control strategy that results in more aggressive postprandial insulin delivery to keep glucose within the target zone. The emphasis is on leveraging the flexible design of zone-MPC to obtain a controller that satisfies glycemic outcomes recommended for pregnancy based on clinical insight. To verify this pregnancy-specific zone-MPC design, we use the UVA/Padova simulator and conduct in-silico experiments on 10 subjects over 13 scenarios ranging from scenarios with ideal metabolic and treatment parameters for pregnancy to extreme scenarios with such parameters that are highly deviant from the ideal. All scenarios had three meals per day and each meal had 40 grams of carbohydrates. Across 13 scenarios, pregnancy-specific zone-MPC led to a 10.3 ± 5.3% increase in the time in pregnancy target range (baseline zone-MPC: 70.6 ± 15.0%, pregnancy-specific zone-MPC: 80.8 ± 11.3%, p < 0.001) and a 10.7 ± 4.8% reduction in the time above the target range (baseline zone-MPC: 29.0 ± 15.4%, pregnancy-specific zone-MPC: 18.3 ± 12.0, p < 0.001). There was no significant difference in the time below range between the controllers (baseline zone-MPC: 0.5 ± 1.2%, pregnancy-specific zone-MPC: 3.5 ± 1.9%, p = 0.1). The extensive simulation results show improved performance in the pregnancy target range with pregnancy-specific zone MPC, suggest robustness of the zone-MPC in tight glucose control scenarios, and emphasize the need for customized glucose control systems for pregnancy.
| S-EPMC8982146 | biostudies-literature
Project description:The role of automated insulin delivery systems in diabetes is expanding. Hybrid closed-loop systems are being used in routine clinical practice for treating people with type 1 diabetes. Encouragingly, real-world data reflects the performance and usability observed in clinical trials. We review the commercially available hybrid closed-loop systems, their distinctive features and the associated real-world data. We also consider emerging indications for closed-loop systems, including the treatment of type 2 diabetes where variability of day-to-day insulin requirements is high, and other challenging applications for this technology. We discuss issues around access and implementation of closed-loop technology, and consider the limitations of present closed-loop systems, as well as innovative approaches that are being evaluated to improve their performance.
| S-EPMC11457686 | biostudies-literature
Project description:BackgroundType 1 diabetes (T1D) is a chronic condition in which the body produces too little insulin, a hormone needed to regulate blood glucose. Various factors such as carbohydrates, exercise, and hormones impact insulin needs. Beyond carbohydrates, most factors remain underexplored. Regulating insulin is a complex control task that can go wrong and cause blood glucose levels to fall outside a range that protects people from adverse health effects. Automated insulin delivery (AID) has been shown to maintain blood glucose levels within a narrow range. Beyond clinical outcomes, data from AID systems are little researched; such systems can provide data-driven insights to improve the understanding and treatment of T1D.ObjectiveThe aim is to discover unexpected temporal patterns in insulin needs and to analyze how frequently these occur. Unexpected patterns are situations where increased insulin does not result in lower glucose or where increased carbohydrate intake does not raise glucose levels. Such situations suggest that factors beyond carbohydrates influence insulin needs.MethodsWe analyzed time series data on insulin on board (IOB), carbohydrates on board (COB), and interstitial glucose (IG) from 29 participants using the OpenAPS AID system. Pattern frequency in hours, days (grouped via k-means clustering), weekdays, and months were determined by comparing the 95% CI of the mean differences between temporal units. Associations between pattern frequency and demographic variables were examined. Significant differences in IOB, COB, and IG across temporal dichotomies were assessed using Mann-Whitney U tests. Effect sizes and Euclidean distances between variables were calculated. Finally, the forecastability of IOB, COB, and IG for the clustered days was analyzed using Granger causality.ResultsOn average, 13.5 participants had unexpected patterns and 9.9 had expected patterns. The patterns were more pronounced (d>0.94) when comparing hours of the day and similar days than when comparing days of the week or months (0.3<d<0.52). Notably, 11 participants exhibited a higher IG overnight despite concurrently higher IOB (10/11). Additionally, 17 participants experienced an increase in IG after COB decreased after meals. The significant associations between pattern frequency and demographics were moderate (0.31≤τ≤0.48). Between clusters, mean IOB (P=.03, d=0.7) and IG (P=.02, d=0.67) differed significantly, but COB did not (P=.08, d=0.55). IOB and IG were most similar (mean distance 5.08, SD 2.25), while COB and IG were most different (mean distance 11.43, SD 2.6), suggesting that AID attempts to counteract both observed and unobserved factors that impact IG.ConclusionsOur study shows that unexpected patterns in the insulin needs of people with T1D are as common as expected patterns. Unexpected patterns cannot be explained by carbohydrates alone. Our results highlight the complexity of glucose regulation and emphasize the need for personalized treatment approaches. Further research is needed to identify and quantify the factors that cause these patterns.
| S-EPMC11612581 | biostudies-literature
Project description:BackgroundClinical trials have demonstrated the efficacy and safety of hybrid closed-loop (HCL) systems, yet few studies have compared outcomes in the real-world setting.MethodThis retrospective study analyzed patients from an academic endocrinology practice between January 1, 2018, and November 18, 2022. The inclusion criteria were diagnosis code for type I diabetes (T1D), >18 years of age, new to any HCL system [Medtronic 670G/770G (MT), Tandem Control IQ (CIQ), or Omnipod 5 (OP5)], and availability of a pump download within three months. The outcomes included %time in range (TIR) of 70 to 180 mg/dL, %time below range (TBR) <70 mg/dL at 90 days, and HbA1c for 91 to 180 days.ResultOf the 176 participants, 47 were MT, 74 CIQ, and 55 OP5. Median (25%, 75%) change in HbA1c was -0.1 (-0.8, 0.3), -0.6 (-1.1, -0.15), and -0.55 (-0.98, 0)% for MT, CIQ, and OP5, respectively, (P = .04). TIR was 70 (57, 76), 67 (59, 75), and 68 (60, 76)% (P = .95) at 90 days while TBR was 2 (1, 3), 1 (0, 2), and 1 (0, 1)%, respectively, (P = .002). The %time in automated delivery was associated with TIR and change in HbA1c. After controlling other factors including %time in automated delivery, HCL type was not an independent predictor of change in HbA1c nor TIR but remained a significant predictor of TBR.ConclusionThere were significant reductions in HbA1c in CIQ and OP5. TIR was similar across pumps, but TBR was highest with MT. The %time in automated delivery likely explains differences in change in HbA1c but not TBR between HCL systems.
| S-EPMC11571516 | biostudies-literature
Project description:ObjectiveMeals are a consistent challenge to glycemic control in type 1 diabetes (T1D). Our objective was to assess the glycemic impact of meal anticipation within a fully automated insulin delivery (AID) system among adults with T1D.Research design and methodsWe report the results of a randomized crossover clinical trial comparing three modalities of AID systems: hybrid closed loop (HCL), full closed loop (FCL), and full closed loop with meal anticipation (FCL+). Modalities were tested during three supervised 24-h admissions, where breakfast, lunch, and dinner were consumed per participant's home schedule, at a fixed time, and with a 1.5-h delay, respectively. Primary outcome was the percent time in range 70-180 mg/dL (TIR) during the breakfast postprandial period for FCL+ versus FCL.ResultsThirty-five adults with T1D (age 44.5 ± 15.4 years; HbA1c 6.7 ± 0.9%; n = 23 women and n = 12 men) were randomly assigned. TIR for the 5-h period after breakfast was 75 ± 23%, 58 ± 21%, and 63 ± 19% for HCL, FCL, and FCL+, respectively, with no significant difference between FCL+ and FCL. For the 2 h before dinner, time below range (TBR) was similar for FCL and FCL+. For the 5-h period after dinner, TIR was similar for FCL+ and FCL (71 ± 34% vs. 72 ± 29%; P = 1.0), whereas TBR was reduced in FCL+ (median 0% [0-0%] vs. 0% [0-0.8%]; P = 0.03). Overall, 24-h control for HCL, FCL, and FCL+ was 86 ± 10%, 77 ± 11%, and 77 ± 12%, respectively.ConclusionsAlthough postprandial control remained optimal with hybrid AID, both fully AID solutions offered overall TIR >70% with similar or lower exposure to hypoglycemia. Anticipation did not significantly improve postprandial control in AID systems but also did not increase hypoglycemic risk when meals were delayed.
| S-EPMC10465820 | biostudies-literature
Project description:Automated insulin delivery (AID) systems play an important role in the management of type 1 diabetes mellitus (T1DM). These systems include three components: a continuous glucose monitor (CGM), an insulin pump and an algorithm that adjusts the pump based on the CGM sensor glucose readings. They are not fully automated and still require the user to administer bolus insulin doses for food. Some AID systems have automatic correction boluses, while others only have automatic basal or background insulin adjustments. As CGM has become more accurate and the technology has evolved, AID systems have demonstrated improved glycaemic outcomes. The clinical evaluation of AID systems in randomized controlled trials and real-world studies have shown their utility in helping glycaemic management. In this review, we compare AID systems that are commercially available in the US and summarize the literature, with a special focus on time in range in T1DM. The review also discusses new AID systems on the horizon and explores considerations for personalized care.
| S-EPMC9354504 | biostudies-literature
Project description:Automated insulin delivery (AID) systems have proven safe and effective in improving glycemic outcomes in individuals with type 1 diabetes (T1D). Clinical evaluation of this technology has progressed to large randomized, controlled outpatient studies and recent commercial approval of AID systems for children and adults. However, several challenges remain in improving these systems for different subpopulations (e.g., young children, athletes, pregnant women, seniors and those with hypoglycemia unawareness). In this review, we highlight the requirements and challenges in AID design for selected subpopulations, and discuss current advances from recent clinical studies.
| S-EPMC8336917 | biostudies-literature