Hybrid Closed-loop Insulin Pump Research Articles

Do hybrid closed loop insulin pump systems improve glycemic control and reduce hospitalizations in poorly controlled type 1 diabetes?

Hybrid closed-loop (HCL) systems improve glycemic control in type 1 diabetes mellitus (T1D), but their effectiveness in young, poorly controlled populations is notestablished and requires study. A pre-post study was performed using electronic health records of patients 3-24 years with baseline HbA1c≥9 % prescribed HCL within the New York City Health+Hospitals System assessing HbA1c levels and hospitalizations before and after HCL initiation and factors associated with achieving HbA1c<9 % after HCLinitiation. Of 47 children and adolescents who met inclusion criteria, 4.68 % female, 95.72 % non-White, and 82.22 % covered by public insurance, with a baseline average HbA1c10.6 % (2.28 IQR). The most prevalent pump type wasOmnipod 5 (70.21 %). The HbA1c was significantly lowerinthe postperiod than baseline (HbA1c before=median 10.6 (IQR2.28), HbA1c after=median 9.33 (IQR 2.97), difference 1.00 (IQR 1.64), p<0.05) with a decrease in median diabetes-related hospitalizations (preperiod 1.00 (IQR 1.00), postperiod 0.00 (IQR 1.00), difference-1.00, IQR 2, p<0.05). Lower baseline HbA1c levels made reaching HbA1c<9 % more likely. Multivariable analysis showed thatthe odds of having HbA1c of <9 % was 2.1 times less likely for every one point increase in baseline HbA1c and 12.5 times less likely for those with a pump at (p<0.05). HCL therapy improved glycemic control and decreased diabetes-related hospitalizations in youth with poorly controlled T1DM. Higher baseline HbA1c levels predicted less success with HCL therapy so those who standto benefit most benefit least.

12518 Development Of A Four-compartment, Dynamic (In Vivo) Model For Insulin Disposition In Healthy Humans: Use Of Fick’s Law To Model Plasma-interstitial Insulin Flux

Abstract Disclosure: R.I. Dorin: None. C.R. Qualls: None. Introduction: Metabolic elimination of insulin (I) in vivo includes pathways mediated by high-affinity and potentially saturable insulin receptor binding; endogenous insulin secreted into the portal vein is subject to first pass elimination. The rate of insulin flux between vascular (Vp) and interstitial (Vi) compartments is often modeled by first order rate constants; here we analyzed an alternative approach using Fick’s law. Methods: The four-compartment, insulin (I) model is expressed by four differential equations that represent I flow (mass/time) in 4 volumes (V) (or compartments) having 3 corresponding elimination rate functions (α): (i) vascular plasma (Vp), (ii) interstitial (Vi, αi), (iii) hepatic (Vh, αh), and (iv) kidney (Vk, αk). Fick’s law was used to model diffusion of insulin between Vp and Vi; Michaelis-Menten like functions were used for saturable elimination functions (αh and αi); rates of hepatic (HPF) and renal (KPF) plasma flow were from literature. Realistic bounds for solved parameters (insulin permeability constant [k, L/min] and αi [min-[1]]) were developed by test bed analysis of published plasma (Ip) and interstitial (Ii) insulin concentration data. The inverse problem (estimating parameters) used Ip data from insulin-modified, frequently sampled iv glucose tolerance (IM-FSIVGT) studies performed in 40 healthy, non-diabetic women (1). Parameter solutions for individual subjects were obtained by iterative least squares method minimizing differences between model-predicted and measured Ip. Results: For infusion of exogenous I (ZI) at a constant rate (e.g., insulin clamp), reported steady state Ii/Ip data suggest that interstitial insulin elimination (αi) is conditionally saturable. Together with non-steady state data for Ip and Ii, initial estimates of k and αi were obtained. Steady state solutions give rise to four algebraic equations: (1) Ii/Ip = a, where a &amp;lt; 1 is consistent with experimental data, (2) Ih is a reduced version of a linear combination of Ip and endogenous insulin secretion (Zβ), where the factor of reduction (b) is &amp;lt;1, (3) Ik/Ip = d, where d&amp;lt;1, and (4) Ip is a linear combination of (i) ZI and (ii) the reduced (by factor b) Zβ. For Ip, this linear combination of ZI and reduced Zβ is also normalized by factor c (weighted sum of k, HPF, and KPF). Conclusions: (i) The proposed insulin flow model using Fick’s law was advantageous in providing realistic parameters and solutions that are tractable to physiologic interpretation, (ii) a simplified version of this model is generalizable to C-peptide, and (iii) since measurement of Ii is impractical in the clinical setting, the proposed prediction model may provide useful modeling adjunct to personalize pharmacokinetic and pharmacodynamic strategies for insulin administered by subcutaneous, iv, and hybrid closed-loop insulin pump routes. 1. Gower et al. Nutrition &amp; Metabolism (2016) 13:2 Presentation: 6/1/2024

6452 Hybrid Closed Loop Insulin Pump Therapy (Omnipod-5, T-Slimx2, Medtronic 780G) in uncontrolled type 1 Diabetes previously treated with multiple daily injections or open loop pumps

6452 Hybrid Closed Loop Insulin Pump Therapy (Omnipod-5, T-Slimx2, Medtronic 780G) in uncontrolled type 1 Diabetes previously treated with multiple daily injections or open loop pumps

Interesting Life Journey of a Type 1 Diabetes Individual from the Era of Injectable Insulins to the Hybrid Closed-Loop Insulin Pump

Abstract Continuous subcutaneous insulin infusion (CSII) pump has shown good outcomes in individuals with diabetes. An individual with type 1 diabetes (T1D) was diagnosed in 1996 at the age of 14 years with GAD-positive and absent C Peptide reserves confirming the diagnosis. Initially, the individual was started with the conventional treatment for T1D consisting of multiple insulin injections per day, however, with this treatment, there was a wide fluctuation in the blood sugar levels with frequent hyperglycemic and hypoglycemic episodes, and could not achieve strict HbA1c control. In 2019, the treatment was switched to a 620G CSII pump, the fluctuations in blood sugar levels were reduced, but still, there were occasional hyperglycemic and hypoglycemic episodes failing to achieve the target HbA1c control. In 2022, again the treatment was changed to the latest 780G CSII pump termed the artificial pancreas which helped the person with T1D to achieve strict blood sugar level control and excellent ‘Time in Range’ with no hyperglycemic and hypoglycemic episodes and a better quality of life.

Hybrid closed-loop insulin pump system: Creating real-world evidence on handling high-protein and high-fat meals

Hybrid closed-loop insulin pump system: Creating real-world evidence on handling high-protein and high-fat meals

Perioperative maintenance of hybrid closed loop insulin pump systems in youth with type 1 diabetes mellitus: A case series.

Current guidelines support the use of continuous glucose monitoring devices and insulin pumps in minor surgical procedures for pediatric patients with type 1 diabetes mellitus. However, there are few reported cases of using hybrid closed loop technology in the perioperative period. This retrospective case series presents seven pediatric patients with type 1 diabetes who underwent eight surgical procedures with maintenance of hybrid closed loop systems. This paper also provides considerations for future use of hybrid closed loop systems perioperatively.

Real-world outcomes of continuous glucose monitoring in adults with diabetes mellitus attending an Irish tertiary hospital.

The American Diabetes Association/European Association for the Study of Diabetes recently recommend the preferential use of continuous glucose monitoring(CGM) over self-monitoring of blood glucose for the management of type 1 diabetes (T1DM). For most adults with T1DM, the recommended target time in range is > 70% with < 4% time below range. In Ireland, CGM use has become increasingly popular since 2021. We aimed to audit adult CGM use and analyse CGM metrics in our cohort of adults with diabetes attending a tertiary diabetes centre. People with diabetes who were using DEXCOM G6 CGM devices, and sharing their data with the healthcare team on the DEXCOM CLARITY for healthcare professionals platform were included in the audit. Clinical information, glycated haemoglobin (HbA1c) and CGM metrics were gathered retrospectively from medical records and the DEXCOM CLARITY platform. Data were available for 119 CGM users, 96.9% with T1DM, median age 36years (IQR = 20) and median diabetes duration 17years (IQR = 20). Fifty-three per cent of the cohort was male. Mean time in range was 56.2% (SD = 19.2) and mean time below range was 2.3% (SD = 2.6). Mean HbA1c in CGM users was 56.7mmol/mol (SD = 13.1). This represented a decrease of 6.7mmol/mol compared to the last HbA1c measurements available pre-commencement of CGM (p ≤ 0.0001, CI 4.4-8.9). The percentage of people in this cohort with a HbA1c < 53mmol/mol was 40.6% (n = 39/96), compared to 17.5% (n = 18/103) pre-commencement of CGM. Our study highlights the challenges in optimising the use of CGM. Our team aims to focus on providing additional education to CGM users, more frequent touch-base virtual reviews and increasing access to hybrid closed-loop insulin pump therapy.

Efficacy of Control-IQ Technology in a General Endocrine Clinic

ObjectiveRecent advances in technology have allowed for the expanded use of hybrid closed-loop insulin pump therapy and automated insulin delivery systems for the management of diabetes mellitus. We assessed the outcomes of introducing Tandem t:slim X2 with the Control-IQ technology in a general endocrine clinic. MethodsData from 66 adults with type 1 (n = 61) and type 2 (n = 5) diabetes mellitus were aggregated for analysis. Patients were either transitioned from traditional insulin pump therapy or multiple daily injection therapy to Tandem t:slim X2 with the Control-IQ technology from January 2020 to June 2021. The assessed clinical end points included changes in time below range, time above range, and time in target range. Changes in hemoglobin A1C before and after Control-IQ technology implementation were noted. The primary outcome was a change in time in target range with the Control-IQ technology. ResultsThere was a significant increase in time in target range when comparing pre- and post–Control-IQ technology (49.5% vs 63.3%, P < .0003) values. There was a reduction in time above range (46.8% vs 34.9%, P < .0013), a decrease in time below range (4.0% vs 1.7%, P = .017), and a decrease in hemoglobin A1C after transitioning to the Control-IQ technology (7.7% [61 mmol/mol] vs 7.1% [54 mmol/mol], P < .017). The patient dropout rate was low (7%). ConclusionThe Control-IQ technology system was effective in reducing hyperglycemia while increasing time in target range and decreasing hypoglycemia. This technology is a useful and effective addition to the growing number of automated insulin delivery systems. The clinical outcomes mirror the results found in the key adult pivotal trials.

Insulin edema after initiation of hybrid closed-loop insulin pump therapy with continuous glucose monitoring: a case report

BackgroundInsulin edema is a rare complication which can present after initiation or intensification of insulin therapy in people with diabetes. Initiation of closed-loop hybrid insulin pump therapy can result in rapid improvement in glycemic control for people with diabetes. We present a case in which transition to a closed-loop hybrid insulin pump system, followed by significant improvement in glycemic control, led to development of insulin edema in a person with type 1 diabetes.Case presentationWe present a 51-year-old woman with type 1 diabetes of 16 years duration, on insulin pump therapy for more than 10 years, who presented for follow-up 7 weeks after transitioning to a hybrid closed-loop insulin pump system with continuous glucose monitoring (CGM). She complained of weight gain and bilateral lower extremity edema which had started two weeks after the change in pump modality. Laboratory studies and echocardiogram did not reveal any etiology of the acute edema. HbA1c was 3.3% lower than the previous measurement 15 weeks earlier, and there was a significant increase in the daily total insulin dose. With exclusion of other causes of acute edema, the patient was diagnosed with insulin edema and started on hydrochlorothiazide. On follow up, her lower extremity edema significantly improved although her weight did not return to baseline.ConclusionTo our knowledge, this is the first case of insulin edema reported in a person with type 1 diabetes using CGM and a hybrid closed-loop insulin pump system. The increase in total daily insulin dose, rapid improvement of glycemic control, and lack of hypoglycemic episodes were important factors to consider in evaluation of this case. Use of hybrid closed-loop systems can help achieve rapid improvement in glycemic control in people with diabetes. This case suggests that consideration should be given to adjusting initial blood glucose targets when starting these remarkable new technologies in people with baseline poor glycemic control.

Benefits and warnings after one year of Minimed 780 G hybrid closed loop pump treatment in type 1 diabetes adults

The benefits of a hybrid closed loop insulin pump system are generally compared to non-automated insulin pump treatment of type 1 diabetics whose glycemic control was often unsatisfactory. Here we report the results of a monocentric cohort of type 1 diabetics with a good glycemic control before the switch to the hybrid system. 83 adult patients were followed up for 12 months after the implementation and training of the hybrid system. We observed a significant improvement in the glycemic mean index at 3 and 6 months but not at 12 months, accompanied by a 10% increase in insulin requirements over the first few months. Surprisingly, the time spent in hypoglycemia did not decrease. An analysis shared with patients leads us to propose several measures to consider before switching to a hybrid closed loop system.

695-P: Comparison of Inpatient Glycemic Control in Hybrid Closed-Loop vs. Sensor-Augmented Insulin Delivery Systems

The hybrid closed-loop (HCL) insulin delivery system is at the forefront of continuous subcutaneous insulin infusion technology. However, to our knowledge, no studies to date have compared inpatient glycemic control between the HCL and non-HCL delivery systems of the HCL insulin pumps. We aim to compare the efficacy and safety of glycemic control between these two insulin delivery systems in the hospital setting. We are performing a prospective study on patients using a HCL insulin pump who are admitted to a non-critical care floor. We included patients who were ≥18 years of age, diagnosed with type 1 or type 2 diabetes, on a HCL insulin pump for more than 4 weeks, and admitted for ≥2 days. The primary outcome is the comparison of percentage of point of care blood glucose readings between 70 and 180 mg/dL in the HCL system versus the non-HCL system. Secondary outcomes include percentage of glucose readings >180 mg/dL and Here, we report preliminary findings of 9 patients using the non-HCL system and 4 patients using the HCL system (Table 1). In the HCL group, >70% of the time was spent in the target blood glucose range of 70-180 mg/dL, 180 mg/dL, and Disclosure Y. Tsushima: None. A. Iqbal: None. J. F. Bena: None. M. Lansang: Consultant; Self; Sanofi. Research Support; Self; Dexcom, Inc.

714-P: Assessment of the Patient Transition Experience to Hybrid Closed-Loop Insulin Pump Therapy

Hybrid closed-loop (HCL) insulin pump therapy is a promising development for the management of type 1 diabetes (T1D), but little is known about the transition period to HCL in a real-world setting. Here, we present novel data evaluating the HCL transition experience and its effect on diabetes distress. We evaluated 32 out of 150 anticipated participants who were about to transition (Arm A), or had recently transitioned (Arm B), from standard pump therapy to the MiniMed™ 670G HCL pump. Patients completed a baseline and 6-month post-transition diabetes distress survey using the T1-DDS. In the follow-up survey, patients’ trust in HCL and treatment satisfaction were also assessed. Finally, post-survey interviews were conducted for patients to elaborate on the successes and struggles of their HCL transition experience. No significant differences were observed between the 2 arms, so the sample was analyzed as a whole. After 6 months on HCL, significant reductions were observed in overall diabetes distress (p&amp;lt;0.0001), as well as powerlessness (p&amp;lt;0.005), management (p&amp;lt;0.001), hypoglycemia (p&amp;lt;0.005), and eating (p&amp;lt;0.0005) distress. Most patients (56%) indicated difficulty trusting HCL, however 80% reported that trust improved over time. Patient satisfaction was high (81%), however only 47% indicated that HCL met their expectations, 56% would recommend HCL to others, and 66% indicated frustration with the transition to HCL. Patients were divided on whether HCL increased (41%) or decreased (47%) the workload required to manage their T1D (12% neutral). Over half of patients (59%) felt that HCL was too complicated. Patients were divided on whether HCL was too much of a “hassle” to use (31% yes, 38% no, 31% neutral). Emerging themes from the qualitative data include numerous alarms, loss of sleep, and necessity of “phantom carbing.” Overall, HCL therapy significantly reduces diabetes distress, but the patient transition experience is varied in terms of trust, satisfaction, and comfort with the technology. Disclosure A. Dissanayake: None. E. Chow: None. A. White: Advisory Panel; Self; Abbott Diabetes, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck &amp; Co., Inc., Novo Nordisk Canada Inc. J. E. Kapeluto: None. J. Mackenzie-feder: None. B. Schroeder: Advisory Panel; Self; AstraZeneca, Novartis Pharmaceuticals Canada Inc. M. Pawlowska: Advisory Panel; Self; Novo Nordisk.

Comparison of the effects of lockdown due to COVID-19 on glucose patterns among children, adolescents, and adults with type 1 diabetes: CGM study

IntroductionThe COVID-19 pandemic forced the Italian government to issue extremely restrictive measures on daily activities since 11 March 2020 (‘lockdown’), which may have influenced the metabolic control of type 1...

A Review of Continuous Glucose Monitoring Data Interpretation in the Age of Automated Insulin Delivery.

Using a continuous glucose monitor (CGM) improves glycemic control in patients with type 1 diabetes. The ambulatory glucose profile (AGP) has been recommended as a standard method for reporting CGM data. However, in recently developed automated insulin delivery (AID) systems, a standard format for reporting data has not yet been developed. Instead, reports are specific to each system being used. Currently, the only FDA approved AID system is a hybrid closed-loop insulin pump. In these systems, the patient is still required to announce a meal, respond to alerts, and keep the system in automated insulin delivery. The integrated pump and sensor information provides insights into how the system is performing, and how to make changes to tunable parameters, such as carbohydrate to insulin ratios. The reports also offer a window into human behavior related to performing diabetes tasks, responding to alarms, reasons for exiting HCL, and how glycemic goals are being met. This article reviews the pump and CGM data provided by several of the current closed-loop systems with a focus on systems that are currently approved in the United States (MiniMed™ 670G, Tandem Basal:IQ) and those used by patients using do-it-yourself systems. A step-wise approach to reviewing the nuances of these systems is provided. The comparison may reinforce the importance of the continued need for streamlining a standard report for providers to be able to interpret the CGM data of these systems.

OR14-5 Challenges in implementing Hybrid Closed Loop Insulin Pump Therapy (medtronic 670g) In A 'Real World' Clinical Setting.

An observation study was conducted at Boston Children’s Hospital on patients with type 1 diabetes mellitus (T1DM) who elected to treat their diabetes with the FDA approved Medtronic 670G hybrid closed loop insulin pump. 83 pediatric and young adults were trained and started on the Medtronic 670G in automode between 5/30/17-9/7/18 (Age range 6-25 years). Average follow up time for the patient population was 8 months (range 3-18 months). 19% (16/83) of T1DM patients discontinued use of automode hybrid closed loop technology completely, often due to technical difficulties with the sensor or difficulties staying in automode. Calibration requirements, problems with sensor durability or adhesion, skin irritation and forced exits from automode were common areas of difficulty. 81% (67/83) continued to use automode although a wide range of percent time in automode was observed (10-90%). A subset of 58 patients who continued to use automode technology and who had available hemoglobin a1c data obtained within 6 months before and within 6 months after starting automode were analyzed . A mean decrease in hemoglobin A1c of 0.27% (95% confidence interval is -0.5, -0.03) was seen after an average of 97 days using automode closed loop technology (P=0.025). In conclusion, our data supports the observation that closed loop insulin delivery in subjects that are successful in using the technology improves glucose control (reduces HbA1c). Additional work is needed to understand barriers to successful implementation of technology.

Technology Advancement: Hybrid Closed-Loop Insulin Pump

Technology Advancement: Hybrid Closed-Loop Insulin Pump

The First Hybrid Closed-Loop Insulin Pump: Will It Meet Its Potential?

The First Hybrid Closed-Loop Insulin Pump: Will It Meet Its Potential?