Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis

Nimri, Revital; Muller, Ido; Atlas, Eran; Miller, Shahar; Kordonouri, Olga; Bratina, Nataša; Tsioli, Christiana; Stefanija, Magdalena Avbelj; Danne, Thomas; Battelino, Tadej; Phillip, Moshe

doi:10.1111/pedi.12071

Cited by 96 publications

(79 citation statements)

References 29 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: 92%

“…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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confidence: 92%

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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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“…Subsequent studies confirmed these findings in outpatient setting, 47 at diabetes camps for children, 48 and at patients' homes. 49 The superior glucose control achieved by these trials suggests that when CGM information is processed appropriately by advanced algorithms, the clinical outcomes are better, even than those achieved by state-of-the art sensoraugmented insulin pump therapy. 50,51 Thus, CGM data contain valuable information reaching beyond the episodic BG determinations provided by SMBG.…”

Section: Utility Of Cgm Informationmentioning

confidence: 99%

Assessing Sensor Accuracy for Non-Adjunct Use of Continuous Glucose Monitoring

Kovatchev

Patek

Ortiz

et al. 2015

Diabetes Technology & Therapeutics

184

154

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Background: The level of continuous glucose monitoring (CGM) accuracy needed for insulin dosing using sensor values (i.e., the level of accuracy permitting non-adjunct CGM use) is a topic of ongoing debate. Assessment of this level in clinical experiments is virtually impossible because the magnitude of CGM errors cannot be manipulated and related prospectively to clinical outcomes. Materials and Methods: A combination of archival data (parallel CGM, insulin pump, self-monitoring of blood glucose [SMBG] records, and meals for 56 pump users with type 1 diabetes) and in silico experiments was used to ''replay'' real-life treatment scenarios and relate sensor error to glycemic outcomes. Nominal blood glucose (BG) traces were extracted using a mathematical model, yielding 2,082 BG segments each initiated by insulin bolus and confirmed by SMBG. These segments were replayed at seven sensor accuracy levels (mean absolute relative differences [MARDs] of 3-22%) testing six scenarios: insulin dosing using sensor values, threshold, and predictive alarms, each without or with considering CGM trend arrows. Results: In all six scenarios, the occurrence of hypoglycemia (frequency of BG levels £ 50 mg/dL and BG levels £ 39 mg/dL) increased with sensor error, displaying an abrupt slope change at MARD = 10%. Similarly, hyperglycemia (frequency of BG levels ‡ 250 mg/dL and BG levels ‡ 400 mg/dL) increased and displayed an abrupt slope change at MARD = 10%. When added to insulin dosing decisions, information from CGM trend arrows, threshold, and predictive alarms resulted in improvement in average glycemia by 1.86, 8.17, and 8.88 mg/dL, respectively. Conclusions: Using CGM for insulin dosing decisions is feasible below a certain level of sensor error, estimated in silico at MARD = 10%. In our experiments, further accuracy improvement did not contribute substantively to better glycemic outcomes.

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“…Comparisons between closed-loop and open-loop insulin delivery systems were performed using the paired nonparametric Wilcoxon signed rank test. The power of the nonparametric tests for the primary endpoint was based on the results of power simulations (MATLAB 2013b, MathWorks) based on previous studies [11,23,24]. We calculated that enrolment of 20 participants would provide a power of 90% for detecting a 30% reduction in the proportion of time spent with blood glucose levels below 3.3 mmol/l, at a 0.05 two-sided significance level, assuming a 30% dropout.…”

Section: Devices and Assaysmentioning

confidence: 99%

Closed-loop glucose control in young people with type 1 diabetes during and after unannounced physical activity: a randomised controlled crossover trial

et al. 2017

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Aims/hypothesis Hypoglycaemia during and after exercise remains a challenge. The present study evaluated the safety and efficacy of closed-loop insulin delivery during unannounced (to the closed-loop algorithm) afternoon physical activity and during the following night in young people with type 1 diabetes. Methods A randomised, two-arm, open-label, in-hospital, crossover clinical trial was performed at a single site in Slovenia. The order was randomly determined using an automated web-based programme with randomly permuted blocks of four. Allocation assignment was not masked. Children and adolescents with type 1 diabetes who were experienced insulin pump users were eligible for the trial. During four separate in-hospital visits, the participants performed two unannounced exercise protocols: moderate intensity (55% of V Á O 2max ) and moderate intensity with integrated highintensity sprints (55/80% of V Á O 2max ), using the same study device either for closed-loop or open-loop insulin delivery. We investigated glycaemic control during the exercise period and the following night. The closed-loop insulin delivery was applied from 15:00 h on the day of the exercise to 13:00 h on the following day.Results Between 20 January and 16 June 2016, 20 eligible participants (9 female, mean age 14.2 ± 2.0 years, HbA 1c 7.7 ± 0.6% [60.0 ± 6.6 mmol/mol]) were included in the trial and performed all trial-mandated activities. The median proportion of time spent in hypoglycaemia below 3.3 mmol/l was 0.00% for both treatment modalities (p = 0.7910). Use of the closed-loop insulin delivery system increased the proportion of time spent within the target glucose range of 3.9-10 mmol/l when compared with open-loop delivery: 84.1% (interquartile range 70.0-85.5) vs 68.7% (59.0-77.7), respectively (p = 0.0057), over the entire study period. This was achieved with significantly less insulin delivered via the closed-loop (p = 0.0123). Conclusions/interpretation Closed-loop insulin delivery was safe both during and after unannounced exercise protocols in the in-hospital environment, maintaining glucose values mostly within the target range without an increased risk of hypoglycaemia.Trial registration Clinicaltrials.gov NCT02657083 Funding

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Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis

Abstract: Original ArticleNight glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial -interim analysis

Cited by 96 publications

References 29 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

Assessing Sensor Accuracy for Non-Adjunct Use of Continuous Glucose Monitoring

Closed-loop glucose control in young people with type 1 diabetes during and after unannounced physical activity: a randomised controlled crossover trial

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