Comparable glucose control with fast-acting insulin aspart versus insulin aspart using a second-generation hybrid closed-loop system during exercise.

Was ist neu? Monitoring Mit der zunehmenden Prävalenz von Continuous-Glucose-Monitoring (CGM) -Systemen gewinnt die Time in Range (TIR) als Parameter zur Optimierung der Blutzuckereinstellung bei Patienten mit Diabetes mellitus Typ 1 an Bedeutung. Zuletzt erfolgte der Nachweis einer verbesserten Prävention von kardiovaskulären Ereignissen und Schwangerschaftskomplikationen bei Patienten mit optimierter TIR. Zusätzlich zur TIR wird empfohlen, die Time below Range (TBR) zu erheben, um Hypoglykämien als klinisch relevante Ereignisse ebenfalls zu erfassen. Hypoglykämien Hypoglykämien bleiben eine klinisch relevante Komplikation der Therapie des Diabetes mellitus Typ 1. Mit der Zulassung von nasalem Glukagon besteht nun gegenüber der klassischen Injektion eine Option als einfach anzuwendende Notfalltherapie. Mit der Entwicklung des im flüssigen Zustand stabilen Glukagon-Analogons Dasiglukagon steht potenziell in naher Zukunft darüber hinaus ein klassischer Notfall-Pen mit Fertiglösung zur Verfügung. Insulintherapie Das neue schnellwirksame Insulin aspart (fast-acting Insulin aspart, FIASP) bietet neue Chancen für die Blutzuckeroptimierung von Typ-1-Diabetespatienten. 2019 wurde darüber hinaus das erste Hybrid-Closed-Loop-System zur Behandlung des Diabetes mellitus Typ 1 in Deutschland zugelassen. Bei diesem System erfolgt eine automatische Anpassung der Basalrate anhand des per CGM gemessenen Blutzuckers. Aufgrund der weiterhin notwendigen Bolusgaben und der Komplexität der Technologie bleibt eine sorgfältige Auswahl und adäquate Schulung der mit einem solchen System therapierten Patienten essenziell. Bei adäquater Anwendung ermöglicht ein Hybrid-Closed-Loop-System eine verbesserte Einstellung insbesondere des nächtlichen Blutzuckers. Ergänzende Therapien Seit 2019 sind der SGLT-2-Inhibitor Dapagliflozin und der kombinierte SGLT-1/2-Inhibitor Sotagliflozin für die Therapie von unzureichend eingestellten Typ-1-Diabetikern mit einem BMI über 27 kg/m² und ohne Risikokonstellation für diabetische Ketoazidosen zugelassen. Die relevanteste Nebenwirkung ist die atypische normoglykäme Ketoazidose, weshalb eine initiale Risikoeinschätzung sowie eine angemessene Schulung des Patienten zur Durchführung und Interpretation von Ketonkörper- und pH-Messungen unter der Therapie von zentraler Bedeutung sind.

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Fast-Acting Insulin Aspart Versus Insulin Aspart Using a Second-Generation Hybrid Closed-Loop System in Adults With Type 1 Diabetes: A Randomized, Open-Label, Crossover Trial

10.2337/figshare.14900547 ◽

2021 ◽

Author(s):

Melissa H. Lee ◽

Barbora Paldus ◽

Sara Vogrin ◽

Dale Morrison ◽

Dessi P. Zaharieva ◽

...

Keyword(s):

Type 1 Diabetes ◽

Insulin Aspart ◽

Glucose Control ◽

Primary Outcome ◽

Closed Loop ◽

Open Label ◽

Modest Improvement ◽

Acting Insulin ◽

Fast Acting

Objective To evaluate glucose control using fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) delivered by the MiniMedä Advanced Hybrid Closed-Loop (AHCL) system in adults with type 1 diabetes. Research Design and Methods In this randomized, open-label, crossover study, participants were assigned to receive faster aspart or IAsp in random-order. Stages 1 and 2 comprised six-weeks in closed-loop; preceded by two-weeks in open-loop. This was followed by Stage 3, whereby participants changed directly back to the insulin formulation used in Stage 1 for one-week in CL. Participants chose their own meals except for two standardized meal tests; a missed and late meal bolus. Primary outcome was % sensor glucose time-in-range (TIR; 70-180mg/dL). Results Twenty-five adults (52% male) were recruited; median (IQR) age was 48 (37, 57) years, and HbA1c 7.0% (6.6, 7.2) (53 [49, 55] mmol/mol). Faster aspart demonstrated greater overall TIR compared with IAsp (82.3% [78.5, 83.7] vs. 79.6% [77.0, 83.4], respectively; mean difference 1.9% [0.5, 3.3]; p=0.007). Four-hour PPG TIR was higher using faster aspart compared with IAsp for all-meals combined (73.6% [69.4, 80.2] vs. 72.1% [64.5, 78.5], respectively; median difference 3.5% [1.0, 7.3]; p=0.003). There was no ketoacidosis or severe hypoglycemia. Conclusions Faster aspart safely improved glucose control compared with IAsp in a well-controlled group of adults with type 1 diabetes using AHCL. The modest improvement mainly related to mealtime glycemia. Whilst the primary outcome demonstrated statistical significance, the clinical impact may be small given an overall difference in TIR of 1.9%.

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Fast-Acting Insulin Aspart Versus Insulin Aspart Using a Second-Generation Hybrid Closed-Loop System in Adults With Type 1 Diabetes: A Randomized, Open-Label, Crossover Trial

10.2337/figshare.14900547.v1 ◽

2021 ◽

Author(s):

Melissa H. Lee ◽

Barbora Paldus ◽

Sara Vogrin ◽

Dale Morrison ◽

Dessi P. Zaharieva ◽

...

Keyword(s):

Type 1 Diabetes ◽

Insulin Aspart ◽

Glucose Control ◽

Primary Outcome ◽

Closed Loop ◽

Open Label ◽

Modest Improvement ◽

Acting Insulin ◽

Fast Acting

Objective To evaluate glucose control using fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) delivered by the MiniMedä Advanced Hybrid Closed-Loop (AHCL) system in adults with type 1 diabetes. Research Design and Methods In this randomized, open-label, crossover study, participants were assigned to receive faster aspart or IAsp in random-order. Stages 1 and 2 comprised six-weeks in closed-loop; preceded by two-weeks in open-loop. This was followed by Stage 3, whereby participants changed directly back to the insulin formulation used in Stage 1 for one-week in CL. Participants chose their own meals except for two standardized meal tests; a missed and late meal bolus. Primary outcome was % sensor glucose time-in-range (TIR; 70-180mg/dL). Results Twenty-five adults (52% male) were recruited; median (IQR) age was 48 (37, 57) years, and HbA1c 7.0% (6.6, 7.2) (53 [49, 55] mmol/mol). Faster aspart demonstrated greater overall TIR compared with IAsp (82.3% [78.5, 83.7] vs. 79.6% [77.0, 83.4], respectively; mean difference 1.9% [0.5, 3.3]; p=0.007). Four-hour PPG TIR was higher using faster aspart compared with IAsp for all-meals combined (73.6% [69.4, 80.2] vs. 72.1% [64.5, 78.5], respectively; median difference 3.5% [1.0, 7.3]; p=0.003). There was no ketoacidosis or severe hypoglycemia. Conclusions Faster aspart safely improved glucose control compared with IAsp in a well-controlled group of adults with type 1 diabetes using AHCL. The modest improvement mainly related to mealtime glycemia. Whilst the primary outcome demonstrated statistical significance, the clinical impact may be small given an overall difference in TIR of 1.9%.

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