Recent in-hospital studies of artificial pancreas (AP) systems have shown promising results in improving glycemic control in patients with type 1 diabetes mellitus. The next logical step in AP development is to conduct transitional outpatient clinical trials with a mobile system that is controlled by the patient. In this article, we present the user interface (UI) of the Diabetes Assistant (DiAs), an experimental smartphone-based mobile AP system, and describe the reactions of a round of focus groups to the UI. This work is an initial inquiry involving a relatively small number of potential users, many of whom had never seen an AP system before, and the results should be understood in that light.
Methods:
We began by considering how the UI of an AP system could be designed to make use of the familiar touch-based graphical UI of a consumer smartphone. After developing a working prototype UI, we enlisted a human factors specialist to perform a heuristic expert analysis. Next we conducted a formative evaluation of the UI through a series of three focus groups with N = 13 potential end users as participants. The UI was modified based upon the results of these studies, and the resulting DiAs system was used in transitional outpatient AP studies of adults in the United States and Europe.
Results:
The DiAs UI was modified based on focus group feedback from potential users. The DiAs was subsequently used in JDRF- and AP@Home-sponsored transitional outpatient AP studies in the United States and Europe by 40 subjects for 2400 h with no adverse events.
Conclusions:
Adult patients with type 1 diabetes mellitus are able to control an AP system successfully using a patient-centric UI on a commercial smartphone in a transitional outpatient environment.
AlbisserAMLeibelBSEwartTGDavidovacZBotzCKZinggW. An artificial endocrine pancreas. Diabetes. 1974; 23 (5): 389–96.
2.
PfeifferEFThumCClemensAH. The artificial beta cell—a continuous control of blood sugar by external regulation of insulin infusion (glucose controlled insulin infusion system). Horm Metab Res. 1974; 6 (5): 339–42.
3.
MirouzeJSelamJLPhamTCCavadoreD. Evaluation of exogenous insulin homoeostasis by the artificial pancreas in insulin-dependent diabetes. Diabetologia. 1977; 13 (3): 273–8.
4.
ClemensAHChangPHMyersRW. The development of Biostator, a glucose controlled insulin infusion system (GCIIS). Horm Metab Res. 1977; Suppl 7: 23–33.
5.
SantiagoJVClemensAHClarkeWLKipnisDM. Closed-loop and open-loop devices for blood glucose control in normal and diabetic subjects. Diabetes. 1979; 28 (1): 71–84.
6.
HovorkaRChassinLJWilinskaMECanonicoVAkwiJAFedericiMOMassi-BenedettiMHutzliIZauggCKaufmannHBothMVeringTSchallerHCSchauppLBodenlenzMPieberTR. Closing the loop: The ADICOL experience. Diabetes Technol Ther. 2004; 6 (3): 307–18.
7.
SteilGMRebrinKDarwinCHaririFSaadMF. Feasibility of automating insulin delivery for the treatment of type 1 diabetes. Diabetes. 2006; 55 (12): 3344–50.
8.
KowalskiAJ. Can we really close the loop and how soon? Accelerating the availability of an artificial pancreas: A roadmap to better diabetes outcomes. Diabetes Technol Ther. 2009; 11Suppl 1: S113–9.
PickupJCKeenHParsonsJAAlbertiKG. Continuous subcutaneous insulin infusion: An approach to achieving normoglycaemia. Br Med J. 1978; 1 (6107): 204–7.
11.
TamborlaneWVSherwinRSGenelMFeligP. Reduction to normal of plasma glucose in juvenile diabetes by subcutaneous administration of insulin with a portable infusion pump. N Engl J Med. 1979; 300 (11): 573–8.
12.
PickupJKeenH. Continuous subcutaneous insulin infusion at 25 years: Evidence base for the expanding use of insulin pump therapy in type 1 diabetes. Diabetes Care. 2002; 25 (3): 593–8.
13.
RenardEGuerciBLeguerrierAMBoizelR; Accu-Chek FlexLink Study Group. Lower rate of initial failures and reduced occurrence of adverse events with a new catheter model for continuous subcutaneous insulin infusion: Prospective, two-period, observational, multicenter study. Diabetes Technol Ther. 2010; 12 (10): 769–73.
FeldmanBBrazgRSchwartzSWeinsteinR. A continuous glucose sensor based on wired enzyme technology — Results from a 3-day trial in patients with type 1 diabetes. Diabetes Technol Ther. 2003; 5 (5): 769–79.
16.
KlonoffDC. Continuous glucose monitoring: Roadmap for 21st century diabetes therapy. Diabetes Care. 2005; 28 (5): 1231–9.
17.
HirschIBArmstrongDBergenstalRMBuckinghamBChildsBPClarkeWLPetersAWolpertH. Clinical application of emerging sensor technologies in diabetes management: Consensus guidelines for continuous glucose monitoring (CGM). Diabetes Technol Ther. 2008; 10 (4): 232–44; quiz 245–6.
18.
Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, TamborlaneWVBeckRWBodeBWBuckinghamBChaseHPClemonsRFiallo-ScharerRFoxLAGilliamLKHirschIBHuangESKollmanCKowalskiAJLaffelLLawrenceJMLeeJMaurasNO'GradyMRuedyKJTanseyMTsalikianEWeinzimerSWilsonDMWolpertHWysockiTXingD. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008; 359 (14): 1464–76.
19.
WeinzimerSASteilGMSwanKLDziuraJKurtzNTamborlaneWV. Fully automated closed-loop insulin delivery versus semiautomated hybrid control in pediatric patients with type 1 diabetes using an artificial pancreas. Diabetes Care. 2008; 31 (5): 934–9.
20.
ClarkeWLAndersonSBretonMPatekSKashmerLKovatchevB. Closed-loop artificial pancreas using subcutaneous glucose sensing and insulin delivery and a model predictive control algorithm: The Virginia experience. J Diabetes Sci Technol. 2009; 3 (5): 1031–8.
21.
BruttomessoDFarretACostaSMarescottiMCVettoreMAvogaroATiengoADallaMan CPlaceJFacchinettiAGuerraSMagniLDe NicolaoGCobelliCRenardEMaranA. Closed-loop artificial pancreas using subcutaneous glucose sensing and insulin delivery and a model predictive control algorithm: Preliminary studies in Padova and Montpellier. J Diabetes Sci Technol. 2009; 3 (5): 1014–21.
22.
MagniLRaimondoDMBossiLManCDDe NicolaoGKovatchevBCobelliC. Model predictive control of type 1 diabetes: An in silico trial. J Diabetes Sci Technol. 2007; 1 (6): 804–12.
23.
HovorkaRAllenJMElleriDChassinLJHarrisJXingDKollmanCHovorkaTLarsenAMNodaleMDe PalmaAWilinskaMEAceriniCLDungerDB. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: A phase 2 randomised crossover trial. Lancet. 2010; 375 (9716): 743–51.
24.
El-KhatibFHRussellSJNathanDMSutherlinRGDamianoER. A bihormonal closed-loop artificial pancreas for type 1 diabetes. Sci Transl Med. 2010; 2 (27): 27ra27.
25.
DassauEZisserHPercivalMWGrosmanBJovanovicLDoyleFJIII. Clinical results of automated artificial pancreatic β-cell system with unannounced meal using multi-parametric MPC and insulin-on-board. Diabetes. 2010; 59 (suppl 1): A94.
26.
AtlasENimriRMillerSGrunbergEAPhillipM. MD-logic artificial pancreas system: A pilot study in adults with type 1 diabetes. Diabetes Care. 2010; 33 (5): 1072–6.
27.
KlonoffDC. The artificial pancreas: How sweet engineering will solve bitter problems. J Diabetes Sci Technol. 2007; 1 (1): 72–81.
28.
ClarkeWLKovatchevB. The artificial pancreas: How close are we to closing the loop?Pediatr Endocrinol Rev. 2007; 4 (4): 314–6.
KovatchevBP. Diabetes technology: Markers, monitoring, assessment, and control of blood glucose fluctuations in diabetes. Scientifica. 2012; 2012: 1–14.
31.
KovatchevBCobelliCRenardEAndersonSBretonMPatekSClarkeWBruttomessoDMaranACostaSAvogaroADallaMan CFacchinettiAMagniLDe NicolaoGPlaceJFarretA. Multinational study of subcutaneous model-predictive closed-loop control in type 1 diabetes mellitus: Summary of the results. J Diabetes Sci Technol. 2010; 4 (6): 1374–81.
32.
HovorkaRKumareswaranKHarrisJAllenJMElleriDXingDKollmanCNodaleMMurphyHRDungerDBAmielSAHellerSRWilinskaMEEvansML. Overnight closed loop insulin delivery (artificial pancreas) in adults with type 1 diabetes: Crossover randomised controlled studies. BMJ. 2011; 342: d1855.
33.
ZisserHDassauEBevierWHarveyRPercivalMWGrosmanBSeborgDJovanovicLDoyleFJ3rd. Initial evaluation of a fully automated artificial pancreas. Diabetes2011; 60 (suppl 1): A255.
34.
KovatchevB. Closed loop control for type 1 diabetes. BMJ. 2011; 342: d1911.
35.
DassauEZisserHCPalermCABuckinghamBJovanovicLJDoyleF3rd. Modular artificial beta-cell system: A prototype for clinical research. J Diabetes Sci Technol. 2008; 2 (5): 863–72.
36.
BretonMFarretABruttomessoDAndersonSMagniLPatekSDallaMan CPlaceJDemartiniSDel FaveroSToffaninCHughes-KarvetskiCDassauEZisserHDoyleFJ3rdDe NicolaoGAvogaroACobelliCRenardEKovatchevB; International Artificial Pancreas Study Group. Fully integrated artificial pancreas in type 1 diabetes: Modular closed-loop glucose control maintains near normoglycemia. Diabetes. 2012; 61 (9): 2230–7.
37.
PhillipMBattelinoTAtlasEKordonouriOBratinaNMillerSBiesterTStefanijaMAMullerINimriRDanneT. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013; 368 (9): 824–33.
38.
KovatchevBPKeith-HynesPTBretonMDPatekSD. Unified platform for monitoring and control of blood glucose levels in diabetic patients. U.S. Patent Application Number PCT/US2012/043910, June 23, 2012.
39.
CobelliCRenardEKovatchevBPKeith-HynesPBrahimBen NPlaceJDel FaveroSBretonMFarretABruttomessoDDassauEZisserHDoyleFJ3rdPatekSDAvogaroA. Pilot studies of wearable outpatient artificial pancreas in type 1 diabetes. Diabetes Care. 2012; 35 (9): e65–7.
40.
KovatchevBPRenardECobelliCZisserHCKeith-HynesPAndersonSMBrownSAChernavvskyDRBretonMDFarretAPelletierMJPlaceJBruttomessoDDel FaveroSVisentinRFilippiAScottonRAvogaroADoyleFJ3rd. Feasibility of outpatient fully integrated closed-loop control: First studies of wearable artificial pancreas. Diabetes Care. 2013; 36 (7): 1851–8.
41.
KovatchevBPCobelliCRenardEZisserHC. Efficacy of outpatient closed-loop control (CLC). Presented at the 73rd American Diabetes Association Scientific Sessions, Chicago, IL, June 21–25, 2013.
42.
Hughes-KarvetskiCGuerlainSKeith-HynesPMcElweeMKovatchevBP. Formative evaluation of the artificial pancreas system user interface. Presented at the 12th Diabetes Technology Meeting, Bethesda, MD, 2012.
