Controlled Insulin Delivery: Combining Technology With Treatment
18. března 2021 aktualizováno: Sansum Diabetes Research Institute
Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric model predictive control can be developed and evaluated safely in patients with Type 1 Diabetes Mellitus (T1DM) to control blood glucose concentrations.
This study seeks to combine real-time continuous glucose sensing with automated insulin delivery in a closed-loop system that will achieve euglycemia in patients with T1DM. The end result of this line of research will be an artificial pancreas that will provide around-the-clock glucose regulation through controlled insulin delivery in response to detected patterns of change in glucose levels.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
The goal of the JDRF Artificial Pancreas Project is to produce an autonomous artificial pancreas that can safely and effectively regulate glycemia in people with type 1 diabetes mellitus.
In our work, this fully automated closed-loop system combines a subcutaneous continuous glucose monitor (CGM) and a continuous subcutaneous insulin infusion (CSII) pump with a sophisticated control algorithm.
This is a proof-of-concept study to demonstrate that the controller could bring the patient back to a relatively normal glucose concentration after an unannounced meal and from mild hyperglycemia.
Once the system is initiated, all insulin delivery is calculated automatically.
There was no outside intervention either by the subject or medical personnel.
An artificial pancreas system that aims at replicating normal beta-cell function by using the subcutaneous-subcutaneous (sc-sc) route needs to address inherent delays in both glucose sensing and insulin delivery.
Our strategic approach is that a closed-loop system should operate safely without any knowledge of meals or other disturbances.
We have developed the Artificial Pancreas System (APS©) and used it to clinically evaluate a control strategy that allows efficient glycemic control without any a priori meal information.
The Artificial Pancreas device uses the Artificial Pancreas System (APS©) platform with the OmniPod insulin pump, the DexCom SEVEN PLUS CGM and a multi-parametric model predictive control algorithm (mpMPC) with an insulin-on-board (IOB) safety constraint.
Typ studie
Intervenční
Zápis (Aktuální)
19
Fáze
- Raná fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Petah Tikva, Izrael
- Schneider Children's Medical Center of Israel
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California
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Santa Barbara, California, Spojené státy, 93105
- Sansum Diabetes Research Institute
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Willing to sign the consent form
- Type 1 diabetes for at least 1 year prior to the study
- Using continuous subcutaneous insulin infusion pump
- Above 21 years of age
- Willing to follow the study requirements
Exclusion Criteria:
- Allergy to the sensor or to one of its components
- Psychiatric disorders
- Reported diabetic ketoacidosis within last 3 months
- Abnormal liver function (Transaminase > 2 times the upper limit of normal)
- Heart failure
- Any carcinogenic disease
- Any other chronic abnormality
- Unwilling to perform or to follow the research protocol
- Participation in any other study concurrent with the proposed study
- Creatinine concentration above the upper limit of normal for age and sex
- Active coronary artery disease
- Active gastroparesis
- History of uncontrolled seizures
- Pregnancy
- Untreated adrenal insufficiency
- Hypokalemia
- Uncontrolled thyroid disease.
- Condition, which in the opinion of the investigator, would interfere with patient safety
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Closed-loop control system
The objective of this study is to automate glucose control in subjects with type 1 diabetes using a computer control algorithm in a controlled in-clinic research setting. The controller will be evaluated under two conditions:
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Subjects will arrive fasting at 7am unless needed for hypoglycemia (glucose < 70 mg/dL) and no extra bolus insulin after 3am. An IV catheter will be inserted for blood samples and for IV administration of glucose if necessary. Blood samples will be analyzed for glucose by YSI 2300Stat every 30 minutes. Breakfast consisting of 25g of CHO will be eaten at 7:30 am and the subject will bolus for this amount of CHO. The controller is switched "on" on the down slope of the meal response, and the subject is brought to a basal steady-state by the controller. Target blood glucose is 110 ± 30-mg/dL. After approximately 3 hours a small lunch will be eaten consisting of 25g of CHO (unannounced meal challenge). The subject will be monitored until blood glucose returns to euglycemia.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Restoration of Euglycemia
Časové okno: 12 hours
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The primary endpoint of this pilot study is successful restoration of euglycemia from the two perturbed conditions using closed loop control with minimal hypo- and hyperglycemia exposure.
The first condition involves restoration of euglycemia when the subject is in a hyperglycemic state.
The second condition involves restoration of euglycemia following consumption of a meal containing 25g CHO with no insulin bolus.
The patients will be followed for the duration of the 12 hour study.
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12 hours
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Average percent-of-time-in-range (80 - 180 mg/dL)
Časové okno: 12 hours
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All reported blood glucose values per both CGM and YSI ware analyzed for average percent-of-time-in-range (80 - 180 mg/dL).
The participants will be followed for the duration of the 12 hour study.
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12 hours
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Lois Jovanovic, M.D., Sansum Diabetes Research Institute
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
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- Diabetes Research in Children Network (DirecNet) Study Group; Buckingham B, Beck RW, Tamborlane WV, Xing D, Kollman C, Fiallo-Scharer R, Mauras N, Ruedy KJ, Tansey M, Weinzimer SA, Wysocki T. Continuous glucose monitoring in children with type 1 diabetes. J Pediatr. 2007 Oct;151(4):388-93, 393.e1-2. doi: 10.1016/j.jpeds.2007.03.047. Epub 2007 Aug 24.
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- Hovorka R, Chassin LJ, Wilinska ME, Canonico V, Akwi JA, Federici MO, Massi-Benedetti M, Hutzli I, Zaugg C, Kaufmann H, Both M, Vering T, Schaller HC, Schaupp L, Bodenlenz M, Pieber TR. Closing the loop: the adicol experience. Diabetes Technol Ther. 2004 Jun;6(3):307-18. doi: 10.1089/152091504774197990.
- Hovorka R, Shojaee-Moradie F, Carroll PV, Chassin LJ, Gowrie IJ, Jackson NC, Tudor RS, Umpleby AM, Jones RH. Partitioning glucose distribution/transport, disposal, and endogenous production during IVGTT. Am J Physiol Endocrinol Metab. 2002 May;282(5):E992-1007. doi: 10.1152/ajpendo.00304.2001.
- Jeha GS, Karaviti LP, Anderson B, Smith EO, Donaldson S, McGirk TS, Haymond MW. Insulin pump therapy in preschool children with type 1 diabetes mellitus improves glycemic control and decreases glucose excursions and the risk of hypoglycemia. Diabetes Technol Ther. 2005 Dec;7(6):876-84. doi: 10.1089/dia.2005.7.876.
- Jones SM, Quarry JL, Caldwell-McMillan M, Mauger DT, Gabbay RA. Optimal insulin pump dosing and postprandial glycemia following a pizza meal using the continuous glucose monitoring system. Diabetes Technol Ther. 2005 Apr;7(2):233-40. doi: 10.1089/dia.2005.7.233.
- Jovanovic L. Role of diet and insulin treatment of diabetes in pregnancy. Clin Obstet Gynecol. 2000 Mar;43(1):46-55. doi: 10.1097/00003081-200003000-00005. No abstract available.
- Kan S, Onodera H, Furutani E, Aung T, Araki M, Nishimura H, Maetani S, Imamura M. Novel control system for blood glucose using a model predictive method. ASAIO J. 2000 Nov-Dec;46(6):657-62. doi: 10.1097/00002480-200011000-00004.
- Kaufman FR. Searching for glycemic control in pediatric type 1 diabetes: A long way to go. J Pediatr. 2001 Aug;139(2):174-6. doi: 10.1067/mpd.2001.117573. No abstract available.
- Klonoff DC. A review of continuous glucose monitoring technology. Diabetes Technol Ther. 2005 Oct;7(5):770-5. doi: 10.1089/dia.2005.7.770. No abstract available.
- Kovatchev BP, Cox DJ, Gonder-Frederick LA, Young-Hyman D, Schlundt D, Clarke W. Assessment of risk for severe hypoglycemia among adults with IDDM: validation of the low blood glucose index. Diabetes Care. 1998 Nov;21(11):1870-5. doi: 10.2337/diacare.21.11.1870.
- Lehmann ED, Deutsch T. A physiological model of glucose-insulin interaction in type 1 diabetes mellitus. J Biomed Eng. 1992 May;14(3):235-42. doi: 10.1016/0141-5425(92)90058-s.
- Lehmann ED, Deutsch T. Compartmental models for glycaemic prediction and decision-support in clinical diabetes care: promise and reality. Comput Methods Programs Biomed. 1998 May;56(2):193-204. doi: 10.1016/s0169-2607(98)00025-x.
- Livesey G, Wilson PD, Dainty JR, Brown JC, Faulks RM, Roe MA, Newman TA, Eagles J, Mellon FA, Greenwood RH. Simultaneous time-varying systemic appearance of oral and hepatic glucose in adults monitored with stable isotopes. Am J Physiol. 1998 Oct;275(4):E717-28. doi: 10.1152/ajpendo.1998.275.4.E717.
- Magni L, Raimondo DM, Man CD, Breton M, Patek S, Nicolao GD, Cobelli C, Kovatchev BP. Evaluating the efficacy of closed-loop glucose regulation via control-variability grid analysis. J Diabetes Sci Technol. 2008 Jul;2(4):630-5. doi: 10.1177/193229680800200414.
- Matsuo Y, Shimoda S, Sakakida M, Nishida K, Sekigami T, Ichimori S, Ichinose K, Shichiri M, Araki E. Strict glycemic control in diabetic dogs with closed-loop intraperitoneal insulin infusion algorithm designed for an artificial endocrine pancreas. J Artif Organs. 2003;6(1):55-63. doi: 10.1007/s100470300009.
- Mauras N, Beck RW, Ruedy KJ, Kollman C, Tamborlane WV, Chase HP, Buckingham BA, Tsalikian E, Weinzimer S, Booth AD, Xing D; Diabetes Research in Children Network (DirecNet) Accuracy Study. Lack of accuracy of continuous glucose sensors in healthy, nondiabetic children: results of the Diabetes Research in Children Network (DirecNet) accuracy study. J Pediatr. 2004 Jun;144(6):770-5. doi: 10.1016/j.jpeds.2004.03.042.
- Owens C, Zisser H, Jovanovic L, Srinivasan B, Bonvin D, Doyle FJ 3rd. Run-to-run control of blood glucose concentrations for people with Type 1 diabetes mellitus. IEEE Trans Biomed Eng. 2006 Jun;53(6):996-1005. doi: 10.1109/TBME.2006.872818.
- Palerm CC, Zisser H, Bevier WC, Jovanovic L, Doyle FJ 3rd. Prandial insulin dosing using run-to-run control: application of clinical data and medical expertise to define a suitable performance metric. Diabetes Care. 2007 May;30(5):1131-6. doi: 10.2337/dc06-2115. Epub 2007 Feb 15.
- Palerm CC, Zisser H, Jovanovic L, Doyle FJ 3rd. A Run-to-Run Control Strategy to Adjust Basal Insulin Infusion Rates in Type 1 Diabetes. J Process Control. 2008;18(3-4):258-265. doi: 10.1016/j.jprocont.2007.07.010.
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- Peterson CM, Jovanovic L, Chanoch LH. Randomized trial of computer-assisted insulin delivery in patients with type I diabetes beginning pump therapy. Am J Med. 1986 Jul;81(1):69-72. doi: 10.1016/0002-9343(86)90184-1.
- Palerm CC, Rodriguez-Fernandez M, Bevier WC, Zisser H, Banga JR, Jovanovic L, Doyle FJ 3rd. Robust parameter estimation in a model for glucose kinetics in type 1 diabetes subjects. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:319-22. doi: 10.1109/IEMBS.2006.260045.
- Shimoda S, Nishida K, Sakakida M, Konno Y, Ichinose K, Uehara M, Nowak T, Shichiri M. Closed-loop subcutaneous insulin infusion algorithm with a short-acting insulin analog for long-term clinical application of a wearable artificial endocrine pancreas. Front Med Biol Eng. 1997;8(3):197-211.
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- Zisser HC, Bevier WC, Jovanovic L. Restoring euglycemia in the basal state using continuous glucose monitoring in subjects with type 1 diabetes mellitus. Diabetes Technol Ther. 2007 Dec;9(6):509-15. doi: 10.1089/dia.2007.0220.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. července 2008
Primární dokončení (Aktuální)
1. ledna 2010
Dokončení studie (Aktuální)
1. ledna 2010
Termíny zápisu do studia
První předloženo
15. listopadu 2011
První předloženo, které splnilo kritéria kontroly kvality
30. listopadu 2011
První zveřejněno (Odhad)
2. prosince 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
23. března 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. března 2021
Naposledy ověřeno
1. března 2021
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- JDRF 22-2009-796
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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