Empfehlungen zur Diabetes-Behandlung mit automatischen Insulin-Dosierungssystemen

ZUSAMMENFASSUNG

Das 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.

Publication History

Article published online:
21 June 2022

• Literatur

• 1 Haak T, Gölz S, Fritsche A. et al Therapie des Typ-1-Diabetes. Kurzfassung der S3-Leitlinie (AWMF-Registernummer: 057–013 2. Auflage). Diabetologie 2020; 15 (Suppl. 01) S40-S50
• 2 Neu A, Bürger-Büsing J, Danne T. et al Diagnostik, Therapie und Verlaufskontrolle des Diabetes mellitus im Kindes- und Jugendalter. Diabetologie 2020; 15 (Suppl. 01) S51-S64
• 3 Heinemann L, Deiss D, Siegmund T. et al Glukosemessung und -kontrolle bei Patienten mit Typ-1- oder Typ-2-Diabetes. Diabetologie 2020; 15 (01) S18-S39
• 4 Biester T, Danne T, Kordonouri O. Auf dem Weg zum Closed Loop – Ziel und Realität. Dtsch MedWochenschr 2017; 142: 731-736
• 5 Tönnies T, Rathmann W.. Epidemiologie des Diabetes in Deutschland. Deutscher Gesundheitsbericht Diabetes 2021: 9-15
• 6 D.u.T Digitalisierungs- und Technologiereport Diabetes 2021. Verlag Kirchheim. 3. Auflage. 2021
• 7 Holl RW, Prinz N.. Für das DPV-Register der pädiatrischen Diabetologie. Versorgung von Kindern und Jugendlichen mit Diabetes – aktuelle Situation und Veränderungen der letzten 25 Jahre Gesundheitsbericht Diabetes. 2021 https://www.deutsche-diabetes-gesellschaft.de/fileadmin/Redakteur/Stellungnahmen/Gesundheitspolitik/Gesundheitsbericht_2021.pdf
• 8 Danne T, Liebl A, Reichel A. et al First User Experience with an Integrated Insulin Pump and Real-Time Continuous Glucose Monitoring System in German Patients with Type 1 Diabetes. Diabetes 2006; 55 (Suppl. 01) A194-A195
• 9 Battelino T, Conget I, Olsen B. et al The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomized controlled trial. Diabetologia 2012; 55 (12) 3155-3162
• 10 Danne T, Kordonouri O, Holder M. et al Prevention of hypoglycemia by using low glucose suspend function in sensor-augmented pump therapy. Diabetes Technol Ther 2011; 13 (11) 1129-1134
• 11 Battelino T, Nimri R, Dovc K. et al Prevention of Hypoglycemia With Predictive Low Glucose Insulin Suspension in ChildrenWith Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Care 2017; 40 (06) 764-770
• 12 Berget C, Lange S, Messer L. et al A clinical review of the t:slim X2 insulin pump. Expert Opin Drug Deliv 2020; 17 (12) 1675-1687
• 13 Biester T, Kordonouri O, Holder M. et al „Let the Algorithm Do theWork“: Reduction of Hypoglycemia Using Sensor-Augmented Pump Therapy with Predictive Insulin Suspension (SmartGuard) in Pediatric Type 1 Diabetes Patients. Diabetes Technol Ther 2017; 19 (03) 173-782
• 14 Lal RA, Basina M, Maahs DM. et al One Year Clinical Experience of the First Commercial Hybrid Closed-Loop System. Diabetes Care 2019; 42 (12) 2190-2196
• 15 Messer LH, Berget C, Vigers T. et al Real world hybrid closed-loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months. Pediatr Diabetes 2020; 21 (02) 319-327
• 16 Wilmot EG, Danne T. DIY artificial pancreas systems: the clinician perspective. Lancet Diabetes Endocrinol 2020; 08 (03) 183-185
• 17 Herzog AL, Busch J, Wanner C. et al Survey about do-it-yourself closed loop systems in the treatment of diabetes in Germany. PLoS ONE 2020; 15: e0243465
• 18 Deutsche Diabetes Gesellschaft Looper Gutachten www.deutsche-diabetes-gesellschaft.de/politik/veroeffentlichungen/looper-gutachten
• 19 https://ec.europa.eu/health/sites/default/files/md_newregulations/docs/md_generic_fs_en.pdf
• 20 Bergenstal RM, Garg S, Weinzimer SA. et al Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA 2016; 316: 1407-1408
• 21 Forlenza GP, Pinhas-Hamiel O, Liljenquist DR. et al Safety Evaluation of the MiniMed 670G System in Children 7–13 Years of Age with Type 1 Diabetes. Diabetes Technol Ther 2019; 21: 11-19
• 22 McAuley SA, Lee MH, Paldus B. et al Six Months of Hybrid Closed-Loop Versus Manual Insulin Delivery With Fingerprick Blood Glucose Monitoring in Adults With Type 1 Diabetes: A Randomized, Controlled Trial. Diabetes Care 2020; 43: 3024-3033
• 23 Breton MD, Kanapka LG, Beck RW. et al A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. N Engl J Med 2020; 383: 836-845
• 24 Brown SA, Kovatchev BP, Raghinaru D. et al Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med 2019; 381 (18) 1707-1717
• 25 Brown SA, Beck RW, Raghinaru D. et al Glycemic Outcomes of Use of CLC Versus PLGS in Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Care 2020: dc200124
• 26 Bergenstal RM, Nimri R, Beck RW. et al A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet 2021; 397: 208-219
• 27 Carlson AL, Bode BW, Brazg RL. et al 97-LB: Safety and Glycemic Outcomes of theMiniMed Advanced Hybrid Closed-Loop (AHCL) Systemin Subjects with T1D American Diabetes Association 80th Scientific Sessions. June 12–16,. 2020 Virtual
• 28 Collyns OJ, Meier RA, Betts ZL. et al Improved Glycemic Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop Delivery: Results From a Randomized Crossover Trial Comparing Automated Insulin Delivery With Predictive Low Glucose Suspend in People With Type 1 Diabetes. Diabetes Care 2021; 44 (04) 969-975
• 29 Tauschmann M, Thabit H, Bally L. et al Closed-loop insulin delivery in suboptimally controlled type 1 diabetes: a multicentre, 12-week randomised trial. Lancet 2018; 392: 1321-1329
• 30 Benhamou PY, Franc S, Reznik Y. et al Closed-loop insulin delivery in adults with type 1 diabetes in real-life conditions: a 12-week multicentre, open-label randomised controlled crossover trial. The Lancet Digital Health 2019; 01: e17-e25
• 31 Tauschmann M, Allen JM, Nagl K. et al Home Use of Day-and-Night Hybrid Closed-Loop Insulin Delivery in Very Young Children: A Multicenter, 3-Week, Randomized Trial. Diabetes Care 2019; 42 (04) 594-600
• 32 Ware J, Allen JM, Boughton CK. et al KidsAP Consortium. Randomized Trial of Closed-Loop Control in Very Young Children with Type 1 Diabetes. N Engl J Med 2022; 386: 209-219
• 33 Musolino G, Dovc K, Boughton CK. et al Consortium. Reduced burden of diabetes and improved quality of life: Experiences from unrestricted day-and-night hybrid closed-loop use in very young children with type 1 diabetes. Pediatr Diabetes 2019; 20: 794-799
• 34 von dem Berge T, Remus K, Biester S. et al In-home use of a hybrid closed loop achieves time-in-range targets in preschoolers and school children: Results from a randomized, controlled, crossover trial. Diabetes Obes Metab 2022 Apr 4
• 35 Ekhlaspour L, Schoelwer MJ, Forlenza GP. et al Safety and Performance of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery System in Toddlers and Preschoolers. Diabetes Technol Ther 2021; 23 (05) 384-391
• 36 Stewart ZA, Wilinska ME, Hartnell S. et al Closedloop insulin delivery during pregnancy in women with type 1 diabetes. N Engl J Med 2016; 375: 644-654
• 37 Stewart ZA, Wilinska ME, Hartnell S. et al Day-andnight closed-loop insulin delivery in a broad population of pregnant women with type 1 diabetes: a randomized controlled crossover trial. Diabetes Care 2018; 41: 1391-1399
• 38 Taleb N, André C, Carpentier AC. et al efficacy of artificial pancreas use in patients with type 2 diabetes using intensive insulin therapy: a randomized crossover pilot trial. Diabetes Care 2019; 42: e107-e109
• 39 Bally L, Thabit H, Hartnell S. et al Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care. N Engl J Med 2018; 379: 547-556
• 40 Lum J, Bailey R, Barnes-Lomen V. et al A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System. Diabetes Technol Ther 23.11.2020
• 41 Petruzelkova L, Jiranova P, Soupal J. et al Pre-school and school-aged children benefit from the switch from a sensor-augmented pump to an AndroidAPS hybrid closed loop: A retrospective analysis. Pediatr Diabetes 2021; 22: 594-604
• 42 Gawrecki A, Zozulinska-Ziolkiewicz D, Michalak MA. et al Safety and glycemic outcomes of do-ityourself AndroidAPS hybrid closed-loop system in adults with type 1 diabetes. PLoS ONE 2021; 16: e0248965
• 43 Schoelwer MJ, Kanapka LG, Wadwa RP. et al Predictors of Time-in-Range (70–180 mg/dL) Achieved Using a Closed-Loop Control System. Diabetes Technol Ther 09.03.2021
• 44 Ehrmann D, Priesterroth L, Schmitt A. et al Associations of Time in Range and Other Continuous Glucose Monitoring–Derived Metrics With Well-Being and Patient-Reported Outcomes: Overview and Trends. Diabetes Spectrum 2021; 34: 149-155
• 45 Berget C, Thomas SE, Messer LH. et al A Clinical Training Program for Hybrid Closed Loop Therapy in a Pediatric Diabetes Clinic. J Diabetes Sci Technol 2020; 14: 290-296
• 46 Messer LH, Berget C, Forlenza GP. A Clinical Guide to Advanced Diabetes Devices and Closed-Loop Systems Using the CARES Paradigm. Diabetes Technology & Therapeutics 2019; 21: 462-469
• 47 Biester T, Bratina N, Lange K. et al Diabetesberatung zum Hybrid-AIDSystem bei Typ-1-Diabetes: neue Perspektiven und Therapieempfehlungen. Diabetologie und Stoffwechsel 2020; 15: 147-156
• 48 Tubiana-Rufi N, Schaepelynck P, Franc S.. SFD Paramedical SFE SFEDP AJD FFD FENAREDIAM and CNP-EDN. Practical implementation of automated closed-loop insulin delivery: A French position statement. Diabetes Metab 02.11.2020; 101206
• 49 Messer LH, Forlenza GP, Sherr JL. Optimizing Hybrid Closed-Loop Therapy in Adolescents and Emerging Adults Using the MiniMed 670G System. Diabetes Care 2018; 41: 789-796
• 50 O‘Malley G, Messer LH, Levy C. et al Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-loop Control System: Results from a 6-month Multicenter Randomized Clinical Trial. Diabetes technology & therapeutics. 2020
• 51 Messer LH. Why Expectations Will Determine the Future of Artificial Pancreas. Diabetes Technol Ther 2018; 20: S265-S268
• 52 O‘Malley G, Messer LH, Levy CJ. et al Clinical Management and Pump Parameter Adjustment of the Control-IQ Closed-Loop Control System: Results from a 6-Month, Multicenter, Randomized Clinical Trial. Diabetes Technol Ther 2021; 23: 245-252
• 53 Cobry EC, Berget C, Messer LH. et al Review of the Omnipod 5 Automated Glucose Control System Powered by Horizon for the treatment of Type 1 diabetes. Ther Deliv 2020; 11: 507-519
• 54 Boughton C, Hartnell S, Allen J. et al Training and support for hybrid closed-loop therapy. J Diabetes Sci Technol 2020
• 55 Hanaire H, Franc S, Borot S. et al Efficacy of the Diabeloop closed-loop system to improve glycaemic control in patients with type 1 diabetes exposed to gastronomic dinners or to sustained physical exercise. Diabetes Obes Metab 2020; 22: 324-334
• 56 Boughton CK, Hartnell S, Allen JM. et al The importance of prandial insulin bolus timing with hybrid closed-loop systems. Diabet Med 2019; 36: 1716-1717
• 57 Jayawardene DC, McAuley SA, Horsburgh JC. et al Closed-Loop Insulin Delivery for Adults with Type 1 Diabetes Undertaking High-Intensity Interval Exercise Versus Moderate-Intensity Exercise: A Randomized, Crossover Study. Diabetes Technol Ther 2017; 19: 340-348
• 58 Dovc K, Macedoni M, Bratina N. et al Closed-loop glucose control in young people with type 1 diabetes during and after unannounced physical activity: a randomised controlled crossover trial. Diabetologia 2017; 60: 2157-2167
• 59 Sherr JL, Buckingham BA, Forlenza GP. et al Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions. Diabetes Technol Ther 2020; 22: 174-184
• 60 Zaharieva DP, Messer LH, Paldus B. et al Glucose Control During Physical Activity and Exercise Using Closed Loop Technology in Adults and Adolescents with Type 1 Diabetes. Can J Diabetes 2020; 44: 740-749
• 61 Aronson R, Li A, Brown RE. et al Flexible insulin therapy with a hybrid regimen of insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise in physically active adults with type 1 diabetes (FIT Untethered): a single-centre, open-label, proof-ofconcept, randomised crossover trial. Lancet Diabetes Endocrinol 2020; 08: 511-523
• 62 Aronson R, Brown RE, Li A. et al Optimal Insulin Correction Factor in Post-High-Intensity Exercise Hyperglycemia in Adults With Type 1 Diabetes: The FIT Study. Diabetes Care 2019; 42: 10-16
• 63 Moser O, Riddell MC, Eckstein ML. et al Glucose management for exercise using continuous glucose monitoring (CGM) and intermittently scanned CGM (isCGM) systems in type 1 diabetes: position statement of the European Association for the Study of Diabetes (EASD) and of the International Society for Pediatric and Adolescent Diabetes (ISPAD) endorsed by JDRF and supported by the American Diabetes Association (ADA). Diabetologia 2020; 63: 2501-2520
• 64 Patel NS, Van Name MA, Cengiz E. et al Mitigating Reductions in Glucose During Exercise on Closed-Loop Insulin Delivery: The Ex-Snacks Study. Diabetes Technol Ther 2016; 18: 794-799
• 65 Wilson LM, Jacobs PG, Ramsey KL. et al Dual-Hormone Closed-Loop System Using a Liquid Stable Glucagon Formulation Versus Insulin-Only Closed-Loop System Compared With a Predictive Low Glucose Suspend System: An Open-Label, Outpatient, Single-Center, Crossover, Randomized Controlled Trial. Diabetes Care 2020; 43: 2721-2729
• 66 Taleb N, Emami A, Suppere C. et al Efficacy of single-hormone and dualhormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial. Diabetologia 2016; 59: 2561-2571
• 67 Rickels MR, DuBose SN, Toschi E. et al Mini-Dose Glucagon Exercise Study Group. Mini-Dose Glucagon as a Novel Approach to Prevent Exercise-Induced Hypoglycemia in Type 1 Diabetes. Diabetes Care 2018; 41: 1909-1916
• 68 Steineck IIK, Ranjan A, Schmidt S. et al Preserved glucose response to low-dose glucagon after exercise in insulin-pump-treated individuals with type 1 diabetes: a randomised crossover study. Diabetologia 2019; 62: 582-592
• 69 Boughton CK, Hartnell S, Thabit H. et al Hybrid Closed loop cluose control with faster insulin aspart (Fiasp) compared with standard insulin aspart in adults with type 1 diaebetes: a double-blind, multicentre, multinational, randomized, crossover study. Diabetes Obes Metab 09.02.2021
• 70 Hsu LJ, Buckingham BA, Basina M. et al Fast-Acting Insulin Aspart Use with the MiniMed 670G System. Diabetes technology & therapeutics 2020
• 71 Bode B, Carlson A, Liu R. et al Ultra Rapid Lispro Demonstrates Similar Time in Target Range to Humalog with the Medtronic MiniMed 670G Hybrid Closed Loop System. Oral Presentation American Diabetes Association Conference 2020
• 72 Messer LH, Berget C, Vigers T. et al Real world hybrid closed-loop discontinuation: Predictors and perceptions of youth discontinuing the 670G system in the first 6 months. Pediatr Diabetes 2020; 21: 319-327
• 73 Karges B, Schwandt A, Heidtmann B. et al Association of Insulin Pump Therapy vs Insulin Injection Therapy With Severe Hypoglycemia, Ketoacidosis, and Glycemic Control Among Children, Adolescents, and Young Adults With Type 1 Diabetes. JAMA 2017; 318: 1358-1366
• 74 Howsmon DP, Baysal N, Buckingham BA. et al Realtime detection of infusion site failures in a closed-loop artificial pancreas. J Diabetes Sci Technol 2018; 12: 599-607
• 75 Cescon M, DeSalvo DJ, Ly TT. et al Early Detection of Infusion Set Failure During Insulin Pump Therapy in Type 1 Diabetes. J Diabetes Sci Technol 2016; 10: 1268-1276
• 76 Messer LH, Berget C, Forlenza GP. A clinical guide to advanced diabetes device and closed-loop systems using the CARES paradigm. Diabetes Technol Ther 2019; 21: 462-469
• 77 Galindo RJ, Umpierrez GE, Rushakoff RJ. et al Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline. J Diabetes Sci Technol 2020; 14: 1035-1064
• 78 Biester T, Muller I, dem Berge T. et al Add-on Therapy with Dapagliflozin under Full Closed Loop Control improves Time in Range in Adolescents and young Adults with Type 1 Diabetes- The DAPADream Study. Diabetes Obes Metab 20.11.2020
• 79 Haidar A, Yale JF, Lovblom LE. et al Reducing the need for carbohydrate counting in type 1 diabetes using closed-loop automated insulin delivery (artificial pancreas) and empagliflozin: A randomized, controlled, noninferiority, crossover pilot trial. Diabetes Obes Metab 2021
• 80 Singh S, Rushakoff RJ, Neinstein AB. A Case Report of Diabetic Ketoacidosis With Combined Use of a Sodium Glucose Transporter 2 Inhibitor and Hybrid Closed-Loop Insulin Delivery. J Diabetes Sci Technol 2019; 13: 605-606
• 81 Haidar A, Tsoukas MA, Bernier-Twardy S. et al a novel dual-hormone insulin-and-pramlintide artificial pancreas for type 1 diabetes: a randomized controlled crossover trial. Diabetes Care 2020; 43: 597-606
• 82 Sherr JL, Patel NS, Michaud CI. et al Mitigating Meal-Related Glycemic Excursions in an Insulin-Sparing Manner During Closed-Loop Insulin Delivery: The Beneficial Effects of Adjunctive Pramlintide and Liraglutide. Diabetes Care 2016; 39: 1127-1134
• 83 Battelino T, Danne T, Bergenstal RM. et al Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care 2019; 42: 1593-1603
• 84 DiMeglio LA, Acerini CL, Codner E. et al ISPAD Clinical Practice Consensus Guidelines 2018: Glycemic control targets and glucose monitoring for children, adolescents, and young adults with diabetes. Pediatric Diabetes 2018; 19: 105-114
• 85 American Diabetes Association Glycemic Targets: Standards of Medical Care in Diabetes 2021. Diabetes Care 2021; 44 (Suppl. 01) S73-S84
• 86 Datz N, Kordonouri O, Danne T. Wenn Menschen mit Typ-1-Diabetes erwachsen werden. Diabetestechnologie und Transition – brauchen wir neue Modelle?. Dtsch Med Wochenschr 2021; 146: 1200-1205
• 87 Messer LH, Tanenbaum ML, Cook PF. et al Cost, hassle, and on-body experience: barriers to diabetes device use in adolescents and potential intervention targets. Diabetes Technol Ther 27.03.2020
• 88 Beato-Víbora PI, Gallego-Gamero F. et al Rapid Improvement in Time in Range After the Implementation of an Advanced Hybrid Closed-Loop System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther 2021
• 89 Bally L, Thabit H, Kojzar H. et al Day-and-night glycaemic control with closed-loop insulin delivery versus conventional insulin pump therapy in free-living adults with well controlled type 1 diabetes: an open-label, randomised, crossover study. Lancet Diabetes Endocrinol 2017; 05: 261-270
• 90 Brown SA, Forlenza GP, Bode BW. et al Multicenter Trial of a Tubeless, On-Body Automated Insulin Delivery System with Customizable Glycemic Targets in Pediatric and Adult Participants with Type 1 Diabetes. Diabetes Care 2021; 44: 1630-1640
• 91 Holt RIG, De Vries JH, Hess-Fischl A. et al The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2021