scholarly journals The Bio-inspired Artificial Pancreas for Type 1 Diabetes Control in the Home: System Architecture and Preliminary Results

2019 ◽  
Vol 13 (6) ◽  
pp. 1017-1025 ◽  
Author(s):  
Pau Herrero ◽  
Mohamed El-Sharkawy ◽  
John Daniels ◽  
Narvada Jugnee ◽  
Chukwuma N. Uduku ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Type 1 Diabetes ◽  
Home Environment ◽  
Closed Loop ◽  
Artificial Pancreas ◽  
Target Range ◽  
Cell Physiology ◽  
Handheld Device ◽  
Preliminary Results

Background: Artificial pancreas (AP) technology has been proven to improve glucose and patient-centered outcomes for people with type 1 diabetes (T1D). Several approaches to implement the AP have been described, clinically evaluated, and in one case, commercialized. However, none of these approaches has shown a clear superiority with respect to others. In addition, several challenges still need to be solved before achieving a fully automated AP that fulfills the users’ expectations. We have introduced the Bio-inspired Artificial Pancreas (BiAP), a hybrid adaptive closed-loop control system based on beta-cell physiology and implemented directly in hardware to provide an embedded low-power solution in a dedicated handheld device. In coordination with the closed-loop controller, the BiAP system incorporates a novel adaptive bolus calculator which aims at improving postprandial glycemic control. This paper focuses on the latest developments of the BiAP system for its utilization in the home environment. Methods: The hardware and software architectures of the BiAP system designed to be used in the home environment are described. Then, the clinical trial design proposed to evaluate the BiAP system in an ambulatory setting is introduced. Finally, preliminary results corresponding to two participants enrolled in the trial are presented. Results: Apart from minor technical issues, mainly due to wireless communications between devices, the BiAP system performed well (~88% of the time in closed-loop) during the clinical trials conducted so far. Preliminary results show that the BiAP system might achieve comparable glycemic outcomes to the existing AP systems (~73% time in target range 70-180 mg/dL). Conclusion: The BiAP system is a viable platform to conduct ambulatory clinical trials and a potential solution for people with T1D to control their glucose control in a home environment.

Artificial Pancreas With Carbohydrate Suggestion Performance for Unannounced and Announced Exercise in Type 1 Diabetes

2020 ◽  
Vol 106 (1) ◽  
pp. 55-63
Author(s):  
Clara Viñals ◽  
Aleix Beneyto ◽  
Juan-Fernando Martín-SanJosé ◽  
Clara Furió-Novejarque ◽  
Arthur Bertachi ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Insulin Pump ◽  
Artificial Pancreas ◽  
Cycle Ergometer ◽  
Open Loop ◽  
Target Range ◽  
Exercise Session ◽  
And Performance

Abstract Objective To evaluate the safety and performance of a new multivariable closed-loop (MCL) glucose controller with automatic carbohydrate recommendation during and after unannounced and announced exercise in adults with type 1 diabetes (T1D). Research Design and Methods A randomized, 3-arm, crossover clinical trial was conducted. Participants completed a heavy aerobic exercise session including three 15-minute sets on a cycle ergometer with 5 minutes rest in between. In a randomly determined order, we compared MCL control with unannounced (CLNA) and announced (CLA) exercise to open-loop therapy (OL). Adults with T1D, insulin pump users, and those with hemoglobin (Hb)A1c between 6.0% and 8.5% were eligible. We investigated glucose control during and 3 hours after exercise. Results Ten participants (aged 40.8 ± 7.0 years; HbA1c of 7.3 ± 0.8%) participated. The use of the MCL in both closed-loop arms decreased the time spent <70 mg/dL of sensor glucose (0.0%, [0.0-16.8] and 0.0%, [0.0-19.2] vs 16.2%, [0.0-26.0], (%, [percentile 10-90]) CLNA and CLA vs OL respectively; P = 0.047, P = 0.063) and the number of hypoglycemic events when compared with OL (CLNA 4 and CLA 3 vs OL 8; P = 0.218, P = 0.250). The use of the MCL system increased the proportion of time within 70 to 180 mg/dL (87.8%, [51.1-100] and 91.9%, [58.7-100] vs 81.1%, [65.4-87.0], (%, [percentile 10-90]) CLNA and CLA vs OL respectively; P = 0.227, P = 0.039). This was achieved with the administration of similar doses of insulin and a reduced amount of carbohydrates. Conclusions The MCL with automatic carbohydrate recommendation performed well and was safe during and after both unannounced and announced exercise, maintaining glucose mostly within the target range and reducing the risk of hypoglycemia despite a reduced amount of carbohydrate intake. Register Clinicaltrials.gov: NCT03577158

Diabeloop DBLG1 Closed-Loop System Enables Patients With Type 1 Diabetes to Significantly Improve Their Glycemic Control in Real-Life Situations Without Serious Adverse Events: 6-Month Follow-up

2021 ◽  
Author(s):  
Coralie Amadou ◽  
Sylvia Franc ◽  
Pierre-Yves Benhamou ◽  
Sandrine Lablanche ◽  
Erik Huneker ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Glycemic Control ◽  
Adverse Events ◽  
Closed Loop ◽  
Artificial Pancreas ◽  
Real Life ◽  
Serious Adverse Events ◽  
Life Conditions ◽  
Time In Range

<b>OBJECTIVE </b> <p>To analyze safety and efficacy of the DBLG1 hybrid closed-loop artificial pancreas system in patients with Type 1 Diabetes in real life conditions. </p> <p> </p> <p><b>METHODS</b></p> <p>Following a one-week run-in period with usual pump, 25 patients were provided with the commercial DBLG1 system. We present the results of Time-in-Range and HbA1c over a 6-month period.</p> <p><b> </b></p> <p><b>RESULTS</b></p> <p>The mean (SD;range) age of patients was 43 years (13.8; 25-72). At baseline, mean HbA1c and TIR 70-180mg/dL were respectively 7.9% (0.93; 5.6- 8.5) [63mmol/mol (10; 38-69)] and 53% (16.4;21-85). One patient stopped using the system after 2 months. At 6-month, mean HbA1c decreased to 7.1% [54mmol/mol] (p<0.001) and TIR 70-180mg/dL increased to 69.7% (p<0.0001). TIR<70mg/dL decreased from 2.4 to 1.3% (p=0.03). TIR<54mg/dL decreased from 0.32 to 0.24% (p=0.42). No serious adverse event was reported during the study. </p> <p> </p> <p><b>CONCLUSION</b></p> <p>The DBLG1 System confirms its ability to significantly improve glycemic control in real life conditions, without serious adverse events. </p>

scholarly journals Fully Automated Closed-Loop Insulin Delivery Versus Semiautomated Hybrid Control in Pediatric Patients With Type 1 Diabetes Using an Artificial Pancreas

Diabetes Care ◽  
2008 ◽  
Vol 31 (5) ◽  
pp. 934-939 ◽  
Author(s):  
S. A. Weinzimer ◽  
G. M. Steil ◽  
K. L. Swan ◽  
J. Dziura ◽  
N. Kurtz ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Pediatric Patients ◽  
Hybrid Control ◽  
Artificial Pancreas ◽  
Insulin Delivery

Overnight Control with Single-Hormone and Dual-Hormone Artificial Pancreas Systems in Type 1 Diabetes: An Outpatient Randomized Trial—Preliminary Results

2014 ◽  
Vol 38 (5) ◽  
pp. S16
Author(s):  
Rohan Rakheja ◽  
Ahmad Haidar ◽  
Émilie D'aoust ◽  
Andrej Orszag ◽  
Marcello Falappa ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Randomized Trial ◽  
Artificial Pancreas ◽  
Preliminary Results

scholarly journals Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes

2021 ◽  
Author(s):  
Olivia J Collyns ◽  
Renee A Meier ◽  
Zara L Betts ◽  
Denis SH Chan ◽  
Chris Frampton ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Insulin Delivery ◽  
Target Range ◽  
Study Phase ◽  
Pump Therapy ◽  
Set Point ◽  
Sensor Glucose ◽  
Low Glucose

Objective:<br><p> To study the MiniMed™ Advanced Hybrid Closed-Loop system (AHCL) which includes an algorithm with individualised basal target set points, automated correction bolus function, and improved Auto Mode stability.<br> Research design and Methods:</p> <p>This dual-centre, randomized, open-label, two-sequence cross-over study in automated insulin delivery naïve participants with type 1 diabetes (aged 7-80yrs), compared AHCL to Sensor Augmented Pump therapy with Predictive Low Glucose Management (SAP+PLGM). Each study phase was 4 weeks, preceded by a 2-4 week run-in, and separated by 2-week washout.</p> <p><a>Results:<b> </b><br> 59/60 people completed the study (mean age 23.3±14.4yrs). Time in target range (TIR) 3.9-10mmol/L (70-180 mg/dL) favoured AHCL over SAP+PLGM (</a>70.4±8.1 vs 57.9±11.7) by 12.5±8.5% (p<0.001), with greater improvement overnight (18.8±12.9%, p<0.001). All age groups (children (7 – 13 years), adolescents (14 – 21 years), and adults (>22 years) demonstrated improvement, with adolescents showing the largest improvement (14.4±8.4%). Mean sensor glucose (SG) at run in was 9.3±0.9 mmol/L (167±16.2mg/dL) and improved with AHCL (8.5±0.7mmol/L (153±12.6mg/dL) (p < 0.001)), but deteriorated during PLGM (9.5±1.1mmol/L (17±19.8mg/dL), (p<0.001)).. TIR was optimal when the algorithm set point was 5.6 mmol/L (100 mg/dL) compared to 6.7 mmol/L (120 mg/dL), 72.0±7.9% vs 64.6±6.9% respectively with no additional hypoglycemia. Auto Mode was active 96.4±4.0% of the time. <a>The percentage of hypoglycemia at baseline (<3.9mmol/L (70mg/dl) and </a> £ 3.0mmol/L(54mg/dl)) was 3.1±2.1% and 0.5±0.6% respectively. During AHCL percentage time <3.9mmol/L (70mg/dl) improved to 2.1±1.4% (p=0.034) (70mg/dl), and was statistically but not clinically reduced for £ 3.0mmol/L(54mg/dl) (0.5±0.5%, p = 0.025) There was one episode of mild diabetic ketoacidosis attributed to an infusion set failure in combination with an intercurrent illness, which occurred during the SAP+PLGM arm.</p> <p>Conclusions</p> <p>AHCL with automated correction bolus demonstrated significant improvement in glucose control compared to SAP+PLGM. A lower algorithm sensor glucose set point during AHCL resulted in greater TIR, with no increase in hypoglycemia.</p>

Progress with Closed-loop Systems in Type 1 Diabetes

2010 ◽  
Vol 6 (2) ◽  
pp. 31
Author(s):  
Lalantha Leelarathna ◽  
Roman Hovorka ◽  
◽  
Keyword(s):  
Type 1 Diabetes ◽  
Closed Loop ◽  
Diabetes Management ◽  
Insulin Delivery ◽  
Glucose Measurement ◽  
Target Range ◽  
Advantages And Disadvantages ◽  
Closed Loop Systems ◽  
Interstitial Glucose

Automated insulin delivery by means of a glucose-responsive closed-loop system has often been cited as the ‘holy grail’ of type 1 diabetes management. Reflecting the technological advances in interstitial glucose measurements and wider use of continuous glucose monitoring, recent research in closed-loop glucose control has focused on the subcutaneous route for glucose measurements and insulin delivery. The primary aim of such systems is to keep blood glucose within the target range while minimising the risk of hypoglycaemia with minimal input from the user. This article examines recent developments in the field of interstitial glucose measurement, limitations of the current generation of devices and implications on the performance of closed-loop systems. Clinical results and the advantages and disadvantages of different closed-loop configurations are summarised. Potential future advances in closed-loop systems are highlighted.

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