In the United States, 18% of people with diagnosed diabetes have visual impairment. Insulin pens are widely used by both blind and sighted people. However, major manufacturers include a disclaimer in the instructions warning against use by visually impaired people, without giving a rationale. Published studies neither support nor refute the disclaimer.
Method:
The purpose of this study was to compare accuracy of dosing with insulin pens between visually impaired and sighted people. Inclusion criteria were self-reported diabetes and inability (visually impaired group) or ability (sighted group) to read regular print. The sole exclusion criterion was inability to pass a brief test of decisional capacity. Each participant received standardized instructions for insulin pen use, either in recorded (visually impaired group) or in printed (sighted group) format, and delivered 10 systematically varied doses into an injection ball, which was weighed on a precision laboratory balance.
Results:
No significant correlation with accuracy of insulin dosing was found for any of the analyzed variables: Visual status, age, gender, years of having diabetes mellitus (DM), or treatment of DM with or without insulin.
Conclusions:
This study provided preliminary evidence of the safety of use of insulin pens by visually impaired people and raised questions about the validity of the disclaimer. Further study of the safety of use of insulin pens by blind people is needed. Inclusion of people with disabilities in research on technology intended for patient use would ensure that people with disabilities can benefit from new technology.
WilliamsA. Diabetes and visual impairment–identifying needs, ensuring full accessibility. Diabetes Voice.2008: 9–12.
4.
BernbaumMAlbertSGBruscaSMcGinnisJMillerDHoffmannJWMooradianAD. Effectiveness of glucose monitoring systems modified for the visually impaired. Diabetes Care.1993;16 (10): 1363–6.
5.
BernbaumMAlbertSGBruscaSRDrimmerADuckroPNCohenJDTrindadeMCSilverbergAB. A model clinical program for patients with diabetes and vision impairment. Diabetes Educ.1989;15 (4): 325–30.
6.
BernbaumMAlbertSGCohenJDDrimmerA. Cardiovascular conditioning in individuals with diabetic retinopathy. Diabetes Care.1989;12 (10): 740–2.
7.
WilliamsAS. A focus group study of accessibility and related psychosocial issues in diabetes education for people with visual impairment. Diabetes Educ.2002;28 (6): 999–1008.
8.
WilliamsAS. Making diabetes education accessible for people with visual impairment. Diabetes Educ.2009;35 (4): 612–21.
9.
Sokol-McKayDBuskirkKWhittakerP. Adaptive low-vision and blindness techniques for blood glucose monitoring. Diabetes Educ.2003;29 (4): 614–8, 620, 622 passim.
10.
BartosBJClearyMEKleinbeckCPetzingerRASokol-McKayDAWhittingtonAWilliamsAS. Diabetes and disabilities: Assistive tools, services, and information. Diabetes Educ.2008;34 (4): 597–8, 600, 603–5 passim.
11.
KleinbeckC. Tools and techniques for visual impairment. Diabetes Self Manag.2006;23 (1): 42, 44, 46, 48–51.
12.
CateYBakerSSGilbertMP. Occupational therapy and the person with diabetes and vision impairment. Am J Occup Ther.1995;49 (9): 905–11.
13.
HergetMJWilliamsAS. New aids for low-vision diabetics. Am J Nurs.1989;89 (10): 1319–22.
NicolucciACucinottaDSquatritoSLapollaAMusacchioNLeottaSVitaliLBulottaANicozianiPCoronelG; QuoLITy Study Group. Clinical and socio-economic correlates of quality of life and treatment satisfaction in patients with type 2 diabetes. Nutr Metab Cardiovasc Dis.2009;19 (1): 45–53.
19.
RubinRRPeyrotM. Quality of life, treatment satisfaction, and treatment preference associated with use of a pen device delivering a premixed 70/30 insulin aspart suspension (aspart protamine suspension/soluble aspart) versus alternative treatment strategies. Diabetes Care.2004;27 (10): 2495–7.
20.
SommavillaBJorgensenCJensenK. Safety, simplicity and convenience of a modified prefilled insulin pen. Expert Opin Pharmacother.2008;9 (13): 2223–32.
21.
RubinRRPeyrotM. Factors affecting use of insulin pens by patients with type 2 diabetes. Diabetes Care.2008;31 (3): 430–2.
22.
KlonoffDC. The pen is mightier than the needle (and syringe). Diabetes Technol Ther.2001;3 (4): 631–3.
23.
SpollettG. Addressing barriers to insulin therapy with the ideal pen. Diabetes Educ.2008;34 (6): 957–67, 963, 967.
ClarkeADainMP. Dose accuracy of a reusable insulin pen using a cartridge system with an integrated plunger mechanism. Expert Opin Drug Deliv.2006;3 (5): 677–83.
27.
HermannsNKulzerBHaakT. Dosing accuracy with a novel pen device (SoloSTAR) as performed by patients with diabetes in a clinical setting. Diabetes Technol Ther.2008;10 (4): 322–7.
28.
SchwartzSVlajnicA. Validation of the SoloSTAR insulin pen. Diabetes Technol Ther.2008;10 (5): 351–7.
29.
PfutznerAAsakuraTSommavillaBLeeW. Insulin delivery with FlexPen: Dose accuracy, patient preference and adherence. Expert Opin Drug Deliv.2008;5 (8): 915–25.
30.
AsakuraTSeinoHKageyamaMYohkohN. Dosing accuracy of two insulin pre-filled pens. Curr Med Res Opin.2008;24 (5): 1429–34.
31.
GnanalinghamMGNewlandPSmithCP. Accuracy and reproducibility of low dose insulin administration using pen-injectors and syringes. Arch Dis Child.1998;79 (1): 59–62.
32.
KeithKNicholsonDRogersD. Accuracy and precision of low-dose insulin administration using syringes, pen injectors, and a pump. Clin Pediatr (Phila).2004;43 (1): 69–74.
33.
LteifANSchwenkWF. Accuracy of pen injectors versus insulin syringes in children with type 1 diabetes. Diabetes Care.1999;22 (1): 137–40.
34.
FoxCMcKinnonCWallALawtonS. Ability to handle, and patient preference for, insulin delivery devices in visually impaired patients with type 2 diabetes. Practical Diabetes Int.2002;19 (4): 104–7.
35.
HaakTEdelmanSWalterCLecointreBSpollettG. Comparison of usability and patient preference for the new disposable insulin device Solostar versus Flexpen, lilly disposable pen, and a prototype pen: An open-label study. Clin Ther.2007;29 (4): 650–60.
36.
AsakuraTSeinoH. Assessment of dose selection attributes with audible notification in insulin pen devices. Diabetes Technol Ther.2005;7 (4): 620–6.
37.
UslanMM. Analysis: Beyond the “clicks” of dose setting in insulin pens. Diabetes Technol Ther.2005;7 (4): 627–8.
38.
BurtonDUslanM. Diabetes and visual impairment: Are insulin pens accessible? Access World [serial on the Internet][cited 2008 Nov 3]. Available from: http://www.afb.org/AFBPress/pub.asp?DocID=aw070403.
PalmerBWDunnLBAppelbaumPSMudaliarSThalLHenryRGolshanSJesteDV. Assessment of capacity to consent to research among older persons with schizophrenia, Alzheimer disease, or diabetes mellitus: Comparison of a 3-item questionnaire with a comprehensive standardized capacity instrument. Arch Gen Psychiatry.2005;62 (7): 726–33.
41.
WilliamsASchnarrenbergerP. Ensuring valid measurements for a disabled population: An insulin pen pilot study. J Diabetes Sci Technol.2010;4 (1): 230.
42.
GrissingerMLeaseM. Misadventures in insulin therapy: Are you at risk?J Natl Med Assoc.2003;95 (2Suppl 1): 1S–16S.
43.
ScottR. The making of blind men: A study of adult socialization. New York: Russell Sage Foundation; 1969.
44.
OmvigJ. Freedom for the blind: The secret is empowerment. Baltimore, MD: National Federation for the Blind; 2005.
45.
TaylorD. A review of rehabilitation in America: Reflections of the past, observations of the present, and speculations about the future. Braille Monitor; 2005.
46.
TuttleDTuttleN. Self-esteem and adjusting with blindness: The process of responding to life's demands. 3rd ed.Springfield, IL: Charles C. Thomas Publishers; 2004.
47.
FiskeSCuddyACGlickPXuJ. A model of (often mixed) stereotype content: Competence and warmth respectively follow from perceived status and competition. J Pers Soc Psychol.2002;82 (6): 878–902.
48.
ShapiroJ. No pity: People with disabilities forging a new civil rights movement. New York: Times Books; 1993.
49.
Americans with Disabilities Act of 1990: Public Law 101–336; 1990.
50.
ConnellBJonesMMaceRMuellerJMullickAOstroffESanfordJSteinfeldEStoryMVanderheidenG. About UD: Universal design principles. Center for Universal Design, North Carolina State University; 1997 [cited 2009 Apr 13]. Available from: http://www.design.ncsu.edu/cud/about_ud/udprincipleshtmlformat.html#top.
