Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial

O’Malley, Grenye; Messer, Laurel H.; Levy, Carol J.; Pinsker, Jordan E.; Isganaitis, Elvira; Kudva, Yogish C.; Ekhlaspour, Laya; Raghinaru, Dan; Lum, John; Brown, Sue A.; Emory, Emma; Voelmle, Mary; Conshafter, Katie; Morris, Kim; Oliveri, Mary C.; Gondor-Fredrick, Linda; Mitchell, Harry; Calvo, Kayla; Wakeman, Christian; Ambler‐Osborn, Louise; Flint, Emily; Kim, Kenny; Roethke, Lindsay; Church, Mei Mei; André, Camille; Piper, Molly; Lam, David W.; Levister, Camilla; Ogyaadu, Selassie; Lovett, Jessica; Simha, Vinaya; Dadlani, Vikash; McCrady-Spitzer, Shelly K.; Reid, Corey; Kumari, Kanchan; Forlenza, Gregory P.; Alonso, G. Todd; Slover, Robert H.; Jost, Emily; Berget, Cari; Towers, Lindsey; Rossick-Solis, Alex; Jacobson, Tali; Town, Marissa; Tabatabai, Ideen; Keller, Jordan; Salas, Evalina; Paulson, John A.; Passman, Samantha; Campos, Tiffany; Kollman, D.R. Craig; Murphy, Carlos; Patibandla, Nandan; Borgman, Sarah; Eggerman, Thomas L.; Green, Neal; Kovatchev, Boris; Anderson, Stacey M.; Breton, Marc D.; Laffel, Lori; Wadwa, R. Paul; Buckingham, Bruce A.; Renard, Éric; Cobelli, Claudio; Reznik, Yves; Arreza-Rubin, Guillermo; Beck, Jan-Philipp

doi:10.1089/dia.2020.0472

Cited by 16 publications

(8 citation statements)

References 13 publications

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“…In addition, there is still ongoing discussion about how effective clinician-led optimization of open-loop parameters are for closed-loop use. 26 Adolescents and young adults, who have shown improvements in their glycemic control with Control-IQ technology use, 27 may have additional educational needs around device use that become apparent over time. Further studies will be needed to determine optimal patient teaching methods and the clinician's role in managing this specific AID system.…”

Section: Discussionmentioning

confidence: 99%

Real-World Patient-Reported Outcomes and Glycemic Results with Initiation of Control-IQ Technology

Pinsker

Müller

Constantin

et al. 2021

Diabetes Technology & Therapeutics

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108

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Background: The t:slim X2Ô insulin pump with Control-IQÔ technology, an advanced hybrid closed-loop system, became available in the United States in early 2020. Real-world outcomes with use of this system have not yet been comprehensively reported. Methods: Individuals with type 1 diabetes (T1D) (‡14 years of age) who had ‡21 days of pump usage data were invited via email to participate. Participants completed psychosocial questionnaires (Technology Acceptance Scale [TAS], well-being index [WHO-5], and Diabetes Impact and Devices Satisfaction [DIDS] scale) at timepoint 1 (T1) (at least 3 weeks after starting Control-IQ technology) and the DIDS and WHO-5 at timepoint 2 (T2) (4 weeks from T1). Patient-reported outcomes (PROs) and glycemic outcomes were reviewed at each timepoint. Results: Overall, 9,085 potentially eligible individuals received the study invite. Of these, 3,116 consented and subsequently 1,435 participants completed questionnaires at both T1 and T2 and had corresponding glycemic data available on the t:connect Ò web application. Time in range was 78.2% (70.2%-85.1%) at T1 and 79.2% (70.3%-86.2%) at T2. PROs reflected high device-related satisfaction and reduced diabetes impact at T2. Factors contributing to high trust in the system included sensor accuracy, improved diabetes control, reduction in extreme blood glucose levels, and improved sleep quality. In addition, participants reported improved quality of life, ease of use, and efficient connectivity to the continuous glucose monitoring system as being valuable features of the system. Conclusions: Continued real-world use of the t:slim X2 pump with Control-IQ technology showed improvements in psychosocial outcomes and persistent achievement of recommended TIR glycemic outcomes in people with T1D.

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Section: Discussionmentioning

confidence: 99%

Real-World Patient-Reported Outcomes and Glycemic Results with Initiation of Control-IQ Technology

Pinsker

Müller

Constantin

et al. 2021

Diabetes Technology & Therapeutics

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108

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“…Some systems benefit from more aggressive ICR (eg, numerically lower ICR) by 10 to 20% ( 116 , 117 ) as compared to open loop settings to help minimize post-meal glucose excursions.…”

Section: Clinical Recommendations For Aid Usementioning

confidence: 99%

Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice

et al. 2022

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The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past six years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.

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“…Das Insulin-zu-Kohlenhydrat-Verhältnis (ICR) sollte regelmäßig überprüft werden, indem die Glukoseexkursionen nach der Mahlzeit beurteilt werden und ein maximaler prandialer Anstieg von < 60 mg/dl (< 3,3 mmol/l) im Vergleich zum präprandialen Ausgangswert angestrebt wird, ähnlich wie bei den Empfehlungen für nicht rückgekoppelte Systeme. Bei einigen Systemen kann ein um 10–20 % stärkerer (d. h. niedrigerer) Mahlzeitenfaktor im Vergleich zu den Einstellungen des offenen Regelkreises erforderlich sein 49 , 50 (z. B. MiniMed 670G, t:slim X2 Control IQ), um die Glukoseexkursionen nach der Mahlzeit zu minimieren 51 , 52 , 53 , bei anderen nicht 54 , 55 (z.…”

Section: Interoperabilität – Die Neue Zukunft In Der Diabetestechnolo...unclassified

Empfehlungen zur Diabetes-Behandlung mit automatischen Insulin-Dosierungssystemen

Berge

Biester

et al. 2022

Diabetes aktuell

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ZUSAMMENFASSUNGDas Prinzip der automatischen Insulindosierung, kurz „AID“ genannt, zeigt in Zulassungsstudien und Real-World-Erfahrungen ausgezeichnete Behandlungsergebnisse. Beim AID wird eine Insulinpumpe mit einem System zur kontinuierlichen Glukosemessung zusammengeschaltet, während ein Rechenprogramm, der sogenannte Algorithmus, die Steuerung der Insulingabe nach Bedarf übernimmt. Idealerweise wäre das System ein geschlossener Kreis, bei dem die Menschen mit Diabetes keine Eingabe mehr machen müssten. Jedoch sind bei den heute verfügbaren Systemen verschiedene Grundeinstellungen und Eingaben erforderlich (insbesondere von Kohlenhydratmengen der Mahlzeiten oder körperlicher Aktivität), die sich von den bisherigen Empfehlungen der sensorunterstützten Pumpentherapie in einzelnen Aspekten unterscheiden. So werden die traditionellen Konzepte von „Basal“ und „Bolus“ mit AID weniger nützlich, da der Algorithmus beide Arten der Insulinabgabe verwendet, um die Glukosewerte dem eingestellten Zielwert zu nähern. Daher sollte bei diesen Systemen statt der Erfassung von „Basal“ und „Bolus“, zwischen einer „nutzerinitiierten“ und einer „automatischen“ Insulindosis unterschieden werden. Gemeinsame Therapieprinzipien der verschiedenen AID-Systeme umfassen die passgenaue Einstellung des Kohlenhydratverhältnisses, die Bedeutung des Timings der vom Anwender initiierten Insulinbolusgaben vor der Mahlzeit, den korrekten Umgang mit einem verzögerten oder versäumten Mahlzeitenbolus, neue Prinzipien im Umgang mit Sport oder Alkoholgenuss sowie den rechtzeitigen Umstieg von AID zu manuellem Modus bei Auftreten erhöhter Ketonwerte. Das Team vom Diabetes-Zentrum AUF DER BULT in Hannover hat aus eigenen Studienerfahrungen und der zugrunde liegenden internationalen Literatur praktische Empfehlungen zur Anwendung und Schulung der gegenwärtig und demnächst in Deutschland kommerziell erhältlichen Systeme zusammengestellt. Für den Erfolg der AID-Behandlung scheint das richtige Erwartungsmanagement sowohl beim Behandlungsteam und als auch beim Anwender von großer Bedeutung zu sein.

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Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial

Cited by 16 publications

References 13 publications

Real-World Patient-Reported Outcomes and Glycemic Results with Initiation of Control-IQ Technology

Real-World Patient-Reported Outcomes and Glycemic Results with Initiation of Control-IQ Technology

Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice

Empfehlungen zur Diabetes-Behandlung mit automatischen Insulin-Dosierungssystemen

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