Time requirements for perioperative glucose management using fully closed-loop versus standard insulin therapy: A proof-of-concept time-motion study.

AIMS: To compare the time required for perioperative glucose management using fully automated closed-loop versus standard insulin therapy. METHODS: We performed a time-motion study to quantify the time requirements for perioperative glucose management with fully closed-loop (FCL) and standard insulin therapy applied to theoretical scenarios. Following an analysis of workflows in different periods of perioperative care in elective surgery patients receiving FCL or standard insulin therapy upon hospital admission (pre- and intra-operatively, at the intermediate care unit and general wards), the time of process-specific tasks was measured by shadowing hospital staff. Each task was measured 20 times and its average duration in combination with its frequency according to guidelines was used to calculate the cumulative staff time required for blood glucose management. Cumulative time was calculated for theoretical scenarios consisting of elective minor and major abdominal surgeries (pancreatic surgery and sleeve gastrectomy, respectively) to account for the different care settings and lengths of stay. RESULTS: The FCL insulin therapy reduced the time required for perioperative glucose management compared to standard insulin therapy, across all assessed care periods and for both perioperative pathways (range 2.1-4.5). For a major abdominal surgery, total time required was 248.5 min using FCL versus 753.9 min using standard insulin therapy. For a minor abdominal surgery, total time required was 68.6 min and 133.2 min for FCL and standard insulin therapy, respectively. CONCLUSIONS: The use of fully automated closed-loop insulin delivery for inpatient glucose management has the potential to alleviate the workload of diabetes management in an environment with adequately trained staff.

Control of blood glucose levels by an artificial pancreas in patients with severe coronavirus disease 2019 pneumonia.

BACKGROUND: Many patients with severe coronavirus disease 2019 (COVID-19) pneumonia experience hyperglycemia. It is often difficult to control blood glucose (BG) levels in such patients using standard intravenous insulin infusion therapy. Therefore, we used an artificial pancreas. This study aimed to compare the BG status of the artificial pancreas with that of standard therapy. METHODS: Fifteen patients were included in the study. BG values and the infusion speed of insulin and glucose by the artificial pancreas were collected. Arterial BG and administration rates of insulin, parenteral sugar, and enteral sugar were recorded during the artificial pancreas and standard therapy. The target BG level was 200 mg/dl. RESULTS: Arterial BG was highly correlated with BG data from the artificial pancreas. A higher BG slightly increased the difference between the BG data from the artificial pancreas and arterial BS. No significant difference in arterial BG was observed between the artificial pancreas and standard therapy. However, the standard deviation with the artificial pancreas was smaller than that under standard therapy (p < 0.0001). More points within the target BG range were achieved with the artificial pancreas (180-220 mg/dl) than under standard therapy. The hyperglycemic index of the artificial pancreas (8.7 ± 15.6 mg/dl) was lower than that of standard therapy (16.0 ± 21.5 mg/dl) (p = 0.0387). No incidence of hypoglycemia occurred under the artificial pancreas. CONCLUSIONS: The rate of achieving target BG was higher using artificial pancreas than with standard therapy. An artificial pancreas helps to control BG in critically ill patients.

Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4.

Background: Automated insulin delivery (AID) systems have proven effective in increasing time-in-range during both clinical trials and real-world use. Further improvements in outcomes for single-hormone (insulin only) AID may be limited by suboptimal insulin delivery settings. Methods: Adults (≥18 years of age) with type 1 diabetes were randomized to either sensor-augmented pump (SAP) (inclusive of predictive low-glucose suspend) or adaptive zone model predictive control AID for 13 weeks, then crossed over to the other arm. Each week, the AID insulin delivery settings were sequentially and automatically updated by an adaptation system running on the study phone. Primary outcome was sensor glucose time-in-range 70-180 mg/dL, with noninferiority in percent time below 54 mg/dL as a hierarchical outcome. Results: Thirty-five participants completed the trial (mean age 39 ± 16 years, HbA1c at enrollment 6.9% ± 1.0%). Mean time-in-range 70-180 mg/dL was 66% with SAP versus 69% with AID (mean adjusted difference +2% [95% confidence interval: -1% to +6%], P = 0.22). Median time <70 mg/dL improved from 3.0% with SAP to 1.6% with AID (-1.5% [-2.4% to -0.5%], P = 0.002). The adaptation system decreased initial basal rates by a median of 4% (-8%, 16%) and increased initial carbohydrate ratios by a median of 45% (32%, 59%) after 13 weeks. Conclusions: Automated adaptation of insulin delivery settings with AID use did not significantly improve time-in-range in this very well-controlled population. Additional study and further refinement of the adaptation system are needed, especially in populations with differing degrees of baseline glycemic control, who may show larger benefits from adaptation.

Non-hybrid glycemic control of type 1 diabetes ambulatory patients

In this work, we present the experience of our research group with the glucose regulation in people with Type 1 Diabetes (insulin-dependent), known as artificial pancreas. Our research group has carried out three clinical trials in Argentina, which were the first ones in Latin America. The first two studies took place in 2016 and 2017, both in the Hospital Italiano de Buenos Aires (HIBA) with five adult subjects and a duration of 36 hours. The second trial evaluated the performance of a novel closed-loop control algorithm (without meal insulin boluses), called ARG (Automatic Regulation of Glucose) and based on switched LQG control and a safety layer called SAFE (Safery Auxiliary Feedback Element), developed by researchers of our team. More recently and during COVID-19 pandemic, the first ambulatory trials took place, which were carried out in 2021 in a hotel with 5 subjects during 6 days. Additionally, for this third trial, the use of the artificial pancreas platform developed by the UNLP, called InsuMate, was incorporated. This platform connects a smartphone with the insulin pump and glucose monitor, houses the control algorithm, and allows the remote monitoring of multiple users. The results suggest that the ambulatory use of the ARG algorithm is feasible, safe and effective, compared to the usual treatment. In addition, the InsuMate platform was intuitive and easy to use for both healthcare staff and participants of the trial, achieving an over 95 % of time in closed-loop.

LAST ADVANCES OF THE ARG ARTIFICIAL PANCREAS PROJECT

Background and Aims: After the artificial pancreas (AP) trials performed in 2016-7 with DiAs system, during the COVID-19 pandemic the first outpatient clinical trial was carried out in Argentina. The main objective was to evaluate the feasibility of running full closed-loop (FCL) algorithms in an own and free platform developed from open-source resources. Methods: The ARG project (Automatic Regulation of Glucose) aims at developing a robust AP algorithm prioritizing patient autonomy. The evolution of the project phases is summarized in the figure. The last step towards this objective was the implementation of a FCL algorithm in our InsuMate platform and its evaluation in an outpatient setting. Five adults with DMT1 completed one week of study, consisting in 3 days of open-loop (OL) followed by 3 days of FCL (i.e., without CHO counting and without delivering meal priming insulin boluses). Accu-Chek pumps and Dexcom G6 CGMs were used. Results: When analyzing the full duration of the trial, the time in range increased in FCL control vs. OL, while the time above range decreased, as did the mean BG. On the other hand, the time below range and the time in severe hypoglycemia remain similar across methods, both achieving the ADA recommended values. The FCL showed greater improvement by the end of the trial, particularly for daytime metrics. InsuMate properly operated in FCL for an average of 95.4% of time. Conclusions: It can be concluded from this experience that the outpatient automatic regulation of glucose levels using the ARG algorithm and Insumate platform is feasible, safe, and effective. (Figure Presented).

Outpatient Full Closed-Loop Trial Using an Open-Source Remote Monitoring and Artificial Pancreas Platform

Objective: The first artificial pancreas (AP) ambulatory clinical trial in Argentina conducted in March 2021 in the COVID-19 pandemic context is reported. The main objective of this trial was to evaluate the feasibility of running advanced full closed-loop (FCL) algorithms for glycemic control in an own and free platform developed by the team at UNLP from open-source resources (www.insumate.com.ar). Method: The ARG algorithm, a FCL algorithm previously evaluated in-vivo [1], was implemented in InsuMate-AP. This platform was then connected to Dexcom G6 CGMs and Accu-Chek Spirit Combo insulin pumps. After configuring conventional open-loop (OL) treatment in the pumps, five adults with Type 1 Diabetes Mellitus completed one week of an ambulatory clinical trial, consisting in 3 days of OL treatment followed by 3 days of FCL glycemic control (i.e., without delivering meal priming insulin boluses). The participants performed regular activities in a hotel, including networking, eating without carbohydrates counting and extensive walking (3-5 km) around the neighborhood. Result: The last 24 hours of each phase were compared, finding a 25,3% increase in time in range (TIR, 70 mg/dl<G<180mg/dl), a 24,5% reduction of the time below range (TBR, G<70 mg/dl) and a 21,1% decrease in time above range (TAR, G>180 mg/dl) during FCL vs OL treatment. The InsuMate system performed reliably and showed good connectivity performance with both the multiple remote monitoring interface and the peripheral devices, achieving adequate FCL operation for 95.4% of time. Conclusion: The InsuMate system and the ARG algorithm were evaluated under challenging and patient-relaxed conditions showing safe and effective behaviour.

Annual ABCD Meeting

The proceedings contain 34 papers. The topics discussed include: the impact of empagliflozin dose on HbA1c and weight outcomes at 6 and 12 months: updated analysis from the ABCD empagliflozin audit program;glycemic outcomes associated with do-it-yourself artificial pancreas systems (DIYAPS): initial insights from the Association of British Clinical Diabetologists' (ABCD) DIYAPS audit program;screening for gestational diabetes: comparing NICE criteria versus RCOG criteria recommended during the COVID pandemic - the role of HbA1c in GDM screening;outcomes in patients with lipodystrophy receiving treatment with metreleptin via the national severe insulin resistance service at Addenbrookes Hospital, Cambridge;mental health case-management significantly reduces hospital admissions and bed days in adults with type 1 diabetes mellitus;and the absence of diabetic autoantibodies when routinely tested in adult-onset type 1 diabetes is associated with a high prevalence of treatment change and successful insulin cessation.

Dietary Changes During COVID-19 Lockdown in Adults With Type 1 Diabetes on a Hybrid Artificial Pancreas.

In this retrospective analysis, we examine the impact of the lockdown of the coronavirus pandemic (COVID-19) on eating habits in individuals with type 1 diabetes (T1D) on a hybrid artificial pancreas (HAP). Dietary composition before and during lockdown was assessed by 7-day food records of 12 participants with T1D on HAP (three men and nine women, ages 38 ± 13 years, HbA1c 6.8 ± 0.3%, M ± SD). Continuous glucose monitoring (CGM) metrics and lifestyle changes (online questionnaire) were also assessed. Compared to prelockdown, reported body weight tended to increase during lockdown with no changes in total energy intake. Participants significantly decreased animal protein intake (-2.1 ± 3.7% of total energy intake, p = 0.048), but tended to increase carbohydrate intake (+17 ± 28 g/day, p = 0.052). These changes were induced by modifications of eating habits at breakfast and lunch during weekdays. Patients consumed more cereals (+21 ± 33 g/day, p = 0.038), whole grain (+22 ± 32 g/day, p = 0.044), and sweets (+13 ± 17 g/day, p = 0.021), and less animal protein sources (-42 ± 67 g/day, p = 0.054). Participants showed a more regular meal timing and decreased physical activity. Blood glucose control remained optimal (time-in-range 76 ± 8 vs. 75 ± 7% before lockdown), and daily total insulin infusion increased (42 ± 10 vs. 39 ± 12 I.U., p = 0.045). During the lockdown, patients with T1D on HAP modified dietary habits by decreasing animal protein and increasing carbohydrate intake. This increase, mainly concerning whole grain and low-glycemic-index products, did not influence blood glucose control.

Newest Diabetes-Related Technologies for Pediatric Type 1 Diabetes and Its Impact on Routine Care: a Narrative Synthesis of the Literature.

Purpose of Review: This review aims to address the actual state of the most advanced diabetes devices, as follows: continuous subcutaneous insulin infusions (CSII), continuous glucose monitoring systems (CGM), hybrid-closed loop (HCL) systems, and "Do-it-yourself" Artificial Pancreas Systems (DIYAPS) in children, adolescents, and young adults. This review has also the objective to assess the use of telemedicine for diabetes care across three different areas: education, social media, and daily care. Recent Findings: Recent advances in diabetes technology after integration of CSII with CGM have increased the popularity of this treatment modality in pediatric age and shifted the standard diabetes management in many countries. We found an impressive transition from the use of CSII and/or CGM only to integrative devices with automated delivery systems. Although much has changed over the past 5 years, including a pandemic period that precipitated a broader use of telemedicine in diabetes care, some advances in technology may still be an additional burden of care for providers, patients, and caregivers. The extent of a higher rate of "auto-mode" use in diabetes devices while using the HCL/DIYAPS is essential to reduce the burden of diabetes treatment. Summary: More studies including higher-risk populations are needed, and efforts should be taken to ensure proper access to cost-effective advanced technology on diabetes care. Supplementary Information: The online version contains supplementary material available at 10.1007/s40124-021-00248-7.

Glucose control using an artificial pancreas in a severe COVID-19 patient on extracorporeal membrane oxygenation: a case report.

The usefulness and safety of continuous glucose monitoring (CGM) systems in adult patients with severe coronavirus disease (COVID-19) have been reported. Using CGM might reduce the exposure patients and healthcare workers to COVID-19 and limit the use of personal protective equipment during the pandemic. CGM devices measure glucose in the subcutaneous interstitial fluid, but the accuracy of this technique has not been established in critically ill patients. The artificial pancreas, STG-55 (Nikkiso, Tokyo), is a closed-loop device that conducts continuous blood glucose monitoring using a peripheral vein. We used the STG-55 for glucose control in a 60-year-old woman with severe COVID-19 admitted to the intensive care unit. Due to severe respiratory failure, the patient was intubated, and extracorporeal membrane oxygenation was introduced. Because she had hyperglycemia despite high-dose intravenous insulin therapy, we decided to use STG-55 for glucose control. The STG-55 safely titrated the insulin infusion and monitored glucose levels. Fifty-six hours after adopting the STG-55, it was removed because the blood sampling failed. No episodes of hypoglycemia were observed despite deep sedation during this period. In conclusion, this case demonstrates the potential utility of an artificial pancreas in patients with severe COVID-19.