Feasibility Study of Automated Overnight Closed-Loop Glucose Control Under MD-Logic Artificial Pancreas in Patients with Type 1 Diabetes: The DREAM Project

Nimri, Revital; Atlas, Eran; Ajzensztejn, Michal; Miller, Shahar; Oron, Tal; Phillip, Moshe

doi:10.1089/dia.2012.0004

Cited by 73 publications

(54 citation statements)

References 22 publications

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“…Results of these studies demonstrate the safety and efficacy of the MD-Logic system, which achieved significantly less hypoglycemia and tighter overnight glucose control than the standard treatment (i.e., continuous subcutaneous insulin infusion or sensor-augmented pump [SAP] therapy) (2,(12)(13)(14).…”

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confidence: 90%

“…Over the past 5 years, a number of studies have been carried out to assess the safety and efficacy of the MD-Logic system for overnight glucose control in children, adolescents, and adults in various settings (2,(12)(13)(14). Results of these studies demonstrate the safety and efficacy of the MD-Logic system, which achieved significantly less hypoglycemia and tighter overnight glucose control than the standard treatment (i.e., continuous subcutaneous insulin infusion or sensor-augmented pump [SAP] therapy) (2,(12)(13)(14).…”

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confidence: 99%

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MD-Logic Overnight Control for 6 Weeks of Home Use in Patients With Type 1 Diabetes: Randomized Crossover Trial

et al. 2014

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OBJECTIVEWe evaluated the effect of the MD-Logic system on overnight glycemic control at patients' homes. RESEARCH DESIGN AND METHODSTwenty-four patients (aged 12-43 years; average A 1c 7.5 6 0.8%, 58.1 6 8.4 mmol/mol) were randomly assigned to participate in two overnight crossover periods, each including 6 weeks of consecutive nights: one under closed loop and the second under sensor-augmented pump (SAP) therapy at patients' homes in real-life conditions. The primary end point was time spent with sensor glucose levels below 70 mg/dL (3.9 mmol/L) overnight. RESULTSClosed-loop nights significantly reduced time spent in hypoglycemia (P = 0.02) and increased the percentage of time spent in the target range of 70-140 mg/dL (P = 0.003) compared with nights when the SAP therapy was used. The time spent in substantial hyperglycemia above 240 mg/dL was reduced by a median of 52.2% (interquartile range [IQR] 4.8, 72.9%; P = 0.001) under closed-loop control compared with SAP therapy. Overnight total insulin doses were lower in the closedloop nights compared with the SAP nights (P = 0.04). The average daytime glucose levels after closed-loop operation were reduced by a median of 10.0 mg/dL (IQR 22.7, 19.2; P = 0.017) while lower total insulin doses were used (P = 0.038). No severe adverse events occurred during closed-loop control; there was a single event of severe hypoglycemia during a control night. CONCLUSIONSThe long-term home use of automated overnight insulin delivery by the MD-Logic system was found to be a feasible, safe, and an effective tool to reduce nocturnal hypoglycemia and improve overnight glycemic control in subjects with type 1 diabetes.The use of a closed-loop system is gaining recognition as a tool for real-time feedback control of insulin delivery for type 1 diabetes (1). A closed-loop insulin delivery system for type 1 diabetes has been tested in hospital settings for overnight (2-4) and also for day and night glycemic control (5,6). Moreover, it has been used for different populations of patients with diabetes: newly diagnosed patients (7), pregnant women (8), those with type 2 diabetes (9), and critically ill patients (10). The

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MD-Logic Overnight Control for 6 Weeks of Home Use in Patients With Type 1 Diabetes: Randomized Crossover Trial

et al. 2014

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“…The main aim is developing an artificial pancreas that has a low cost to be suitable for patients with type 1diabetes and artificial pancreas should be reliable with small size. There are many control techniques have been utilised for the artificial pancreas, such as PID control [20][21][22][23][24][25], adaptive control [26,27], model-predictive control [28], fuzzy logic control [29,30] and linear -quadratic Gaussian [25,31].…”

Section: Modelling An Artificial Pancreasmentioning

confidence: 99%

Proposed Procedure to Improve Performance of an Artificial Pancreas and Pancreas Transplant: Review

Algaddafi¹,

Ali²

2017

J Diabetes Metab

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Diabetes is a lifelong condition with no cure. Diabetes has a serious effect on the patient, especially pregnant women that may cause problems, whether overdose or low of the insulin in the blood stream. The patient must use insulin whether by pumping as in the artificial pancreas (closed loop) or by injecting insulin manual (opened loop). However, every method has its own advantages and disadvantages, e.g. the opened loop system for artificial pancreas may have a risk during the night when the patient sleep. On the other hand, the closed loop can administer insulin and glucose at the right time with the right amount. However, the artificial pancreas is not available yet and it required more improvement to be reliable. The algorithm of artificial pancreas consists of measuring glucose in the blood of a patient by using glucose sensor and sends a signal to an insulin pump to adjust basal insulin rated according to the desired amount of insulin that the patient need. This procedure required devices with the patient; however, some patient may be advised to have a pancreas transplant.This paper reviews the current publication of an artificial pancreas and proposed a method to improve the control of an artificial pancreas. History of diabetes is described in this paper with a critical review of current studies. Also, it has tested pre-diabetes for pregnant women. The obtain results show that in breakfast the sugar level is increased high with random changing, hence based on the test, some foods should be ignored in breakfast, while other food recommended.

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“…Some systems use insulin as well as glucagon in dual hormone artificial pancreas (AP) systems, 55 although clinical applicability at present for bi-hormonal systems is limited due to lack of stable glucagon preparations. Numerous studies have emerged testing AP control algorithms initially under clinical research settings, 56 subsequently to controlled diabetes camp use 55,57 and now being brought to home use. 58,59 These studies have shown exciting and promising data on improved glucose variability, increasing time in target BG range, and without an increase in hypoglycemia frequency or SH rates.…”

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confidence: 99%

Technology to Reduce Hypoglycemia

Yeoh

Choudhary

2015

J Diabetes Sci Technol

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Hypoglycemia remains a major limiting factor toward the intensification of treatment for diabetes mellitus 1 and is a major cost to patients and to health care systems. 2 Hypoglycemia is often divided into mild or nonsevere hypoglycemia episodes (NSHE), where the person is able to selftreat, and severe hypoglycemia (SH), where external assistance is required. It is difficult to set a biochemical threshold for hypoglycemia, as the glucose threshold at which symptoms of hypoglycemia can be detected vary between individuals and even from day to day within the same person.3 The ADA workgroup on hypoglycemia offers some consensus guidelines, defining an alert value of ≤70 mg/dl, measured through self-monitored blood glucose (SMBG) or subcutaneous continuous glucose monitoring (CGM), as indicative of the potential for developing hypoglycemia. 4 All those treated with insulin secretagogues (sulphonylureas, glinides) and insulin therapy are at risk of hypoglycemia, and this risk is increased in the presence of endogenous insulin deficiency, longer duration of diabetes and longer duration of insulin therapy.5 Epidemiological data suggest that people with type 1 diabetes (T1D) with optimal glycemic control experience up to 2 mild episodes/week, with 20-30% experiencing episodes severe enough to require external help in any given year.6 A small proportion of these people, usually with impaired awareness of hypoglycemia, contribute to more than half of the incidence of SH, having recurrent disabling and sometimes life threatening events. 7CGM studies designed to study normative data suggest that while hypoglycemia is common in all insulin-treated people with diabetes, compared to subjects with type 2 diabetes (T2D), T1D subjects had twice as many hypoglycemic episodes per day, with more hours per day in the hypoglycemic range.8 However, although the incidence per patient of NSHE and SH is lower in T2D, due to the greater prevalence of T2D, the majority of episodes of SH occur in people with T2D. 9 In the US, rates of admissions for hypoglycemia have increased in recent years to 105 admissions per 100 000 person-years. 10 Antecedent hypoglycemia has been shown to blunt symptom and counter-regulatory hormonal responses to subsequent hypoglycemia.11 Over time, recurrent hypoglycemia eventually leads to a reduction in the ability to detect hypoglycemia and mount a hormonal response to it, known as impaired awareness of hypoglycemia (IAH) which can increase the risk of SH 6-fold. 12 In the T1D Exchange clinic registry, ≥ 1 SH events occurred in ~6% of over 9000 participants within 12 months, and was not associated with baseline glycated hemoglobin (HbA1c) levels. 13 Undoubtedly, SH has substantial clinical consequences on morbidity (both physical and psychological) and mortality. The more subtle effects of SH and hypoglycemia unawareness are often AbstractHypoglycemia is a major barrier toward achieving glycemic targets and is associated with significant morbidity (both psychological and physical) and mortality. This article re...

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Feasibility Study of Automated Overnight Closed-Loop Glucose Control Under MD-Logic Artificial Pancreas in Patients with Type 1 Diabetes: The DREAM Project

Abstract: Closed-loop insulin delivery under MDLAP is a feasible and safe solution to control overnight glycemia.

Cited by 73 publications

References 22 publications

MD-Logic Overnight Control for 6 Weeks of Home Use in Patients With Type 1 Diabetes: Randomized Crossover Trial

MD-Logic Overnight Control for 6 Weeks of Home Use in Patients With Type 1 Diabetes: Randomized Crossover Trial

Proposed Procedure to Improve Performance of an Artificial Pancreas and Pancreas Transplant: Review

Technology to Reduce Hypoglycemia

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