A multicenter, open-label, randomized, two-period crossover trial comparing glycemic control, satisfaction, and preference achieved with a 31 gauge x 6 mm needle versus a 29 gauge x 12.7 mm needle in obese patients with diabetes mellitus

Clinical Therapeutics

Volumn 26, Issue 10, 2004, Pages 1663-1678

  Schwartz, Sherwyn ^a   Hassman, David ^b   Shelmet, John ^c   Sievers, Richard ^d   Weinstein, Richard ^e   Liang, John ^f   Lyness, William ^f  

^a Diabet/Glandular Dis Res Assoc   (United States)

^b New Jersey USA ^*  (United States)

^c New Jersey USA   (United States)

^d Wells Institute   (United States)

^e Diablo Clinical Research   (United States)

^f NOVO NORDISK INC   (United States)

Author keywords

dermal thickness; glycosylated hemoglobin; needle length; quality of life

Indexed keywords

GLYCOSYLATED HEMOGLOBIN; INSULIN;

ABDOMEN; ADULT; AGED; ARTICLE; BODY MASS; CAPILLARY RESISTANCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; CROSSOVER PROCEDURE; DEVICE; DIABETES CONTROL; DIABETES MELLITUS; DRUG DELIVERY SYSTEM; FEMALE; GLUCOSE BLOOD LEVEL; GLYCOSYLATION; HEMOGLOBIN DETERMINATION; HUMAN; INJECTION SITE; INTERMETHOD COMPARISON; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NEEDLE; OBESITY; PAIN ASSESSMENT; PATIENT SATISFACTION; PATIENT SELECTION; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; STATISTICAL SIGNIFICANCE; THIGH; WORLD HEALTH ORGANIZATION;

ADULT; AGED; CROSS-OVER STUDIES; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; EQUIPMENT DESIGN; FEMALE; HEMOGLOBIN A, GLYCOSYLATED; HUMANS; HYPOGLYCEMIC AGENTS; INJECTIONS, SUBCUTANEOUS; INSULIN; MALE; MIDDLE AGED; NEEDLES; OBESITY; OUTCOME ASSESSMENT (HEALTH CARE); PAIN MEASUREMENT; PATIENT SATISFACTION; QUALITY OF LIFE; QUESTIONNAIRES; SKINFOLD THICKNESS; UNITED STATES;

EID: 10444287638     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2004.10.007     Document Type: Article

References (17)

1. Kuczmarski R.J., Carroll M.D., Flegal K.M., and Troiano R.P. Varying body mass index cutoff points to describe overweight prevalence among US adults: NHANES III (1988-1994) Obes Res 5 1997 542 548
2. Flegal K.M., Carroll M.D., Kuczmarski R.J., and Johnson C.L. Overweight and obesity in the United States: Prevalence and trends, 1960-1994 Int J Obes Relat Metab Disord 22 1998 39 47
3. Abstract Pemberton E., and Holman R.R. Optimal needle length for subcutaneous injection Diabet Med 6 Suppl 2 1989 91
4. Abstract Solvig J., Sandahi J., Christiansen B.H., and Lytzen L. Needle length affects insulin deposition in normal and obese diabetes patients Diabetes 50 2001 A132
5. Igls, Austria Sorensen J.P., and Hansen B. Determination of pain on needle penetration using 27, 28 and 30 gauge Insuject needles Poster presented at: Annual meeting of the Artificial Insulin Delivery Systems, Pancreatic and Islet Transportation Study Group of the EuropeanAssociation for the Study of Diabetes January 1990
6. Igls, Austria Lytzen L., Hansen B., and Sorensen T.K. Pain perception and frequency of bleeding Poster presented at: Artificial Insulin Delivery Systems and Pancreatic and Islet Transportation meeting January 1993
7. Abstract P123 van Doorn L.G., Alberda A., and Lytzen L. Insulin leakage and pain perception with NovoFine® 6 mm and NovoFine® 2 mm needle lengths in patients with Type 1 or 2 diabetes Diabet Med 15 1998 S50
8. Molin A., Larsen C., and Lawton S.A. Reduced flow resistance in insulin pen needles designed with thin wall technology Diabetes 51 Suppl 2 2002 A475
9. Thow J.C., Johnson A.B., Fulcher G., and Home P.D. Different absorption of isophane (NPH) insulin from subcutaneous and intramuscular sites suggest a need to reassess recommended insulin injectiontechnique Diabet Med 7 1990 600 602
10. Birkebaek N.H., Johansen A., and Solvig J. Cutis/subcutis thickness at insulin injection sites and localization of simulated insulin boluses in children with type 1 diabetes mellitus: Needfor individualization of injection technique? Diabet Med 15 1998 965 971
11. Tubiana-Ruff N., Belarbi N., and Du Pasquier-Fediaevsky L. Short needles (8 mm) reduce the risk of intramuscular injections in children with type 1 diabetes Diabetes Care 22 1999 1621 1625
12. Ross S.A., Jamal R., and Leiter L.A. Evaluation of 8 mm insulin pen needles in people with type 1 and type 2 diabetes Pract Diabet Int 16 1999 145 148
13. World Medical Association Declaration of Helsinki Recommendations guiding physicians in biomedical research involving human subjects JAMA 277 1997 925 926
14. Anderson R.T., Skovlund S.E., and Marrero D. Development and validation of the Insulin Treatment Satisfaction Questionnaire Clin Ther 26 2004 565 578
15. Bradley C., and Lewis K.S. Measures of psychological wellbeing and treatment satisfaction developed from the responses of people with tablet-treated diabetes Diabet Med 7 1990 445 451
16. Byron J., and Kenward M.G. Design and Analysis of Cross-over Trials 2nd ed 2003 Chapman & Hall/CRC Boca Raton, Fla
17. Frid A., and Linden B. Where do lean diabetics inject their insulin? A study using computed tomography BMJ (Clin Res Ed) 292 1986 1638