Controlled Insulin Delivery: Combining Technology With Treatment
18. marts 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
19
Fase
- Tidlig fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Santa Barbara, California, Forenede Stater, 93105
- Sansum Diabetes Research Institute
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Petah Tikva, Israel
- Schneider Children's Medical Center of Israel
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Restoration of Euglycemia
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Average percent-of-time-in-range (80 - 180 mg/dL)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lois Jovanovic, M.D., Sansum Diabetes Research Institute
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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- Steil GM, Panteleon AE, Rebrin K. Closed-loop insulin delivery-the path to physiological glucose control. Adv Drug Deliv Rev. 2004 Feb 10;56(2):125-44. doi: 10.1016/j.addr.2003.08.011.
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- Bequette BW. A critical assessment of algorithms and challenges in the development of a closed-loop artificial pancreas. Diabetes Technol Ther. 2005 Feb;7(1):28-47. doi: 10.1089/dia.2005.7.28.
- Bevier WC, Zisser H, Palerm CC, Finan DA, Seborg DE, Doyle FJ, Wollitzer AO, Jovanovic L. Calculating the insulin to carbohydrate ratio using the hyperinsulinaemic-euglycaemic clamp-a novel use for a proven technique. Diabetes Metab Res Rev. 2007 Sep;23(6):472-8. doi: 10.1002/dmrr.727.
- Bode BW. Clinical utility of the continuous glucose monitoring system. Diabetes Technol Ther. 2000;2 Suppl 1:S35-41. doi: 10.1089/15209150050214104. No abstract available.
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- Broekhuyse HM, Nelson JD, Zinman B, Albisser AM. Comparison of algorithms for the closed-loop control of blood glucose using the artificial beta cell. IEEE Trans Biomed Eng. 1981 Oct;28(10):678-87. doi: 10.1109/tbme.1981.324661. No abstract available.
- Chanoch LH, Jovanovic L, Peterson CM. The evaluation of a pocket computer as an aid to insulin dose determination by patients. Diabetes Care. 1985 Mar-Apr;8(2):172-6. doi: 10.2337/diacare.8.2.172.
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- Dassau E, Palerm CC, Zisser H, Buckingham BA, Jovanovic L, Doyle FJ. In silico evaluation platform for artificial pancreatic beta-cell development--a dynamic simulator for closed-loop control with hardware-in-the-loop. Diabetes Technol Ther. 2009 Mar;11(3):187-94. doi: 10.1089/dia.2008.0055.
- Dassau E, Zisser H, C Palerm C, A Buckingham B, Jovanovic L, J Doyle F 3rd. Modular artificial beta-cell system: a prototype for clinical research. J Diabetes Sci Technol. 2008 Sep;2(5):863-72. doi: 10.1177/193229680800200518.
- 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.
- Dua P, Doyle FJ 3rd, Pistikopoulos EN. Model-based blood glucose control for Type 1 diabetes via parametric programming. IEEE Trans Biomed Eng. 2006 Aug;53(8):1478-91. doi: 10.1109/TBME.2006.878075.
- Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2006 Jan;29(1):44-50. doi: 10.2337/diacare.29.01.06.dc05-1686.
- 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.
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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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2008
Primær færdiggørelse (Faktiske)
1. januar 2010
Studieafslutning (Faktiske)
1. januar 2010
Datoer for studieregistrering
Først indsendt
15. november 2011
Først indsendt, der opfyldte QC-kriterier
30. november 2011
Først opslået (Skøn)
2. december 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. marts 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. marts 2021
Sidst verificeret
1. marts 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- JDRF 22-2009-796
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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