Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial

Bosi, Emanuele; Choudhary, Pratik; Valk, Harold W. de; Lablanche, Sandrine; Castañeda, Javier; Portu, Simona de; Silva, Julien Da; Ré, Roseline; Groot, Linda Vorrink-de; Shin, John; Kaufman, Francine; Cohen, Ohad; Laurenzi, Andrea; Caretto, Amelia; Slatterly, David; Henderson-Wilson, Marcia; Weisnagel, S. John; Dubé, Marie Christine; Julien, V; Trevisan, Roberto; Lepore, Giuseppe; Bellante, Rosalia; Hramiak, Irene; Spaic, Tamara; Driscoll, Marsha; Borot, Sophie; Clergeot, Annie; Khiat, Lamia; Hammond, Peter J.; Ray, Sutapa; Dinning, Laura; Tonolo, Giancarlo; Manconi, Alberto; Ledda, Maura Serena; Ranitz, Wendela de; Silvius, Bianca; Wojtusciszyn, Anne; Farret, Anne; Vriesendorp, Titia M.; Jong, Folkje Immeker-de; Linden, Joke van der; Brink, H S; Alkemade, M; Schaepelynck-Bélicar, P.; Galie, Sébastien; Treglia, C.; Benhamou, Pierre Yves; Haddouche, Myriam; Hoogma, Roel P.L.M.; Leelarathna, Lalantha; Shaju, Angel; James, L M

doi:10.1016/s2213-8587(19)30150-0

Cited by 98 publications

(102 citation statements)

References 36 publications

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“…Recent technological advances in diabetes treatment have integrated continuous subcutaneous insulin delivery (CSII) with CGM, where insulin delivery can be automated by sensor glucose (SG)-driven algorithms. Insulin delivery suspension when reaching a low glucose level [3,4] or in prediction of a low glucose level [5,6] has demonstrated significant reduction in hypoglycemia exposure.…”

Section: Introductionmentioning

confidence: 99%

10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes

et al. 2020

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Aim The aim of this study was to evaluate the 10-day initiation protocol for MiniMed 670G hybrid closed-loop (HCL) system in individuals with type 1 diabetes on multiple daily injection (MDI) in achieving desirable glycemic control. Methods An open-label single-arm, single-center, clinical investigation in children aged 7-18 years on MDI following a structured protocol: 2 days, HCL system assessment; 5 days, HCL system training (2-h sessions on 5 consecutive days with groups of 3-5 participants and families); 3 days, Manual Mode use of HCL system; 84 days, Auto Mode use of the HCL system, cumulating in 10 days from MDI to Auto Mode activation. Results A total of 30 children (age 10.24 ± 2.6 years) were enrolled in the study, and all completed the planned 84 days on Auto Mode. The participants used the sensor for a median of 92% of the time and spent a median of 89% in Auto Mode. The mean HbA1c decreased from 8.2 ± 1.4% (66 ± 15.3 mmol/mol) at baseline to 6.7 ± 0.5% (50 ± 5.5 mmol/mol) at the end of the study (p = 0.017). Time in range (70-180 mg/dL) increased from 46.9 ± 18.5% at baseline to 75.6 ± 6.9% in Auto Mode (p < 0.001). This was achieved while spending 2.8% of the time below 70 mg/dL and without any severe hypoglycemia or DKA. Conclusion Children and adolescents with type 1 diabetes on MDI therapy can successfully initiate the HCL system, using a concise structured 10-day protocol.

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Section: Introductionmentioning

confidence: 99%

10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes

et al. 2020

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“…The use of continuous glucose monitoring (CGM) associated with insulin pump therapy, the so-called sensor-augmented pump (SAP) therapy, has shown a reduction in non-severe and severe hypoglycaemia in people with T1D prone to this adverse event [ 6 – 9 ]. These findings lend support to the broad adoption and national health system reimbursement of this technology in the management of this high-risk population.…”

Section: Introductionmentioning

confidence: 99%

Management of glucose profile throughout strict COVID-19 lockdown by patients with type 1 diabetes prone to hypoglycaemia using sensor-augmented pump

et al. 2020

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Aims Spain has been one of the worst affected countries by the COVID-19 pandemic. A very strict lockdown at home was imposed with a tough restriction of mobility. We aimed to evaluate the impact of this exceptional scenario on glucose profile of patients with type 1 diabetes (T1D) prone to hypoglycaemia using sensor-augmented pump (SAP). Methods Patients with T1D prone to hypoglycaemia using SAP (640G Medtronic-Minimed ® ) for at least 6 months under the funding of a National Health Service were included in an observational, retrospective study. Data were collected in two periods: pre-lockdown (PL), February 23rd–March 7th and within lockdown (WL), April 1st to 14th 2020. The primary outcome was the difference in the proportion of time in target glucose range of 70–180 mg/dL (TIR). Additional glucometric data and total daily insulin were also analysed. Results Fifty-nine patients were included: 33 women, age 46.17 ± 13.0 years and disease duration of 30.2 ± 12.0 years. TIR 70–180 mg/dL (67.6 ± 11.8 vs. 69.8 ± 12.0%), time > 180 (28.1 ± 13.6 vs. 25.5 ± 13.1%), time > 250 (6.9 ± 6.1 vs. 5.1 ± 4.8) and estimated HbA 1c (6.94 ± 0.8 vs. 6.75 ± 0.7%) significantly improved (PL vs. WL, respectively, p < 0.05). Time in hypoglycaemia, coefficient of variation, sensor usage and total daily insulin dose remained unchanged. Conclusions Lockdown conditions imposed by the COVID-19 pandemic may be managed successfully in terms of glycaemia control by population with DT1 prone to hypoglycaemia using SAP. The strict daily routine at home could probably explain the improvement in the time in glycemic target without increasing the time hypoglycaemia.

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“…Das System besitzt zwei Optionen, den "manuellen Modus" und dem "Auto-Modus". Im "manuellen Modus" arbeitet es wie eine Insulinpumpe mit angekoppeltem Glukosesensor bei einer sensorunterstützten Pumpentherapie mit der gleichen Funktionalität wie das Vorgängermodell [10,11].…”

Section: Funktionsweise Des Hybrid-aid-systemsunclassified

“…B. Dualbolus, verlängerter Bolus) sind im "Auto-Modus" daher nicht erforderlich und entsprechend nicht vorhanden. Den Bolus immer vor dem Essen abgeben(10)(11)(12)(13)(14)(15).▪ Die Kohlenhydratmenge sollte genau bestimmt werden, anfangs möglichst mithilfe einer Küchenwaage. ▪ Zu große Mahlzeiten sollten vermieden werden (nicht mehr als 100 g Kohlenhydrate pro Mahlzeit bzw.…”

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Diabetesberatung zum Hybrid-AID-System bei Typ-1-Diabetes: neue Perspektiven und Therapieempfehlungen

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et al. 2020

Diabetologie und Stoffwechsel

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ZusammenfassungKontinuierliche Glukosemonitoringsysteme (CGM) haben inzwischen eine so hohe Messqualität erreicht, dass automatisierte therapeutische Entscheidungen und eine bedarfsgerechte automatisierte Insulinzufuhr möglich geworden sind. Dazu werden CGM und Insulinpumpen zu einem „AID-System“ (Automated Insulin Delivery) zusammengeführt. Ein Algorithmus errechnet dabei kontinuierlich aus den gemessenen Glukosewerten unter Berücksichtigung individueller Nutzerdaten die Insulindosis. Idealerweise verringert sich damit der Einfluss des „Human-Faktors“, d. h. die notwendige manuelle Steuerung der Insulinabgabe durch den Nutzer. Seit 2016 steht in den USA, seit 2018 in einigen europäischen Ländern und seit 2019 in Deutschland ein Hybrid-AID für Personen mit Typ-1-Diabetes zur Verfügung. Der Begriff „Hybrid“ bezeichnet dabei die automatische adaptive Zufuhr des nahrungsunabhängigen, basalen Insulinanteils und die manuelle Abgabe des Insulinbolus zu den Mahlzeiten. Derzeit setzen ca. 200 000 Personen mit Diabetes weltweit ein solches System ein.Dieses, aber auch zukünftige Systeme zur vollautomatischen Insulinabgabe setzen voraus, dass die Nutzer ihr AID-System verstehen und in ungewöhnlichen oder kritischen Situationen sachgerecht reagieren können. Damit ist eine qualifizierte Schulung gerade zu diesen neuen Technologien aus unserer Sicht unverzichtbar. Nutzer können nur dann von den Vorteilen des Systems profitieren, wenn sie verstehen, weshalb ein automatisierter Modus verlassen wird, und sie im manuellen Modus sicher und korrekt handeln können. In diesem Beitrag werden relevante Aspekte und zentrale Herausforderungen bei der Schulung zum Hybrid-AID System MiniMed 670G dargestellt.

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Efficacy and safety of suspend-before-low insulin pump technology in hypoglycaemia-prone adults with type 1 diabetes (SMILE): an open-label randomised controlled trial

Cited by 98 publications

References 36 publications

10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes

10-Day structured initiation protocol from multiple daily injection to hybrid closed-loop system in children and adolescents with type 1 diabetes

Management of glucose profile throughout strict COVID-19 lockdown by patients with type 1 diabetes prone to hypoglycaemia using sensor-augmented pump

Diabetesberatung zum Hybrid-AID-System bei Typ-1-Diabetes: neue Perspektiven und Therapieempfehlungen

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