Validation of the SoloSTAR insulin pen

Diabetes Technology and Therapeutics

Volumn 10, Issue 5, 2008, Pages 351-357

  Schwartz, Sherwyn ^a   Vlajnic, Aleksandra ^b  

^a Diabetes and Glandular Disease Clinic   (United States)

^b SANOFI   (France)

Author keywords

[No Author keywords available]

Indexed keywords

INSULIN GLARGINE; ORAL ANTIDIABETIC AGENT;

ACCURACY; ADULT; AGED; ARTICLE; CLINICAL TRIAL; DEVICE; DIABETES MELLITUS; DIABETIC NEUROPATHY; DIABETIC RETINOPATHY; DISPOSABLE EQUIPMENT; FEMALE; GLYCEMIC CONTROL; HUMAN; INSULIN DEPENDENT DIABETES MELLITUS; INSULIN PUMP; INSULIN TREATMENT; MAJOR CLINICAL STUDY; MALE; NON INSULIN DEPENDENT DIABETES MELLITUS; OPEN STUDY; PATIENT SAFETY; PRIORITY JOURNAL; STATISTICAL ANALYSIS; TRAINING;

ADULT; AGED; BLOOD GLUCOSE; DIABETES MELLITUS, TYPE 1; DIABETES MELLITUS, TYPE 2; DISPOSABLE EQUIPMENT; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; HYPOGLYCEMIC AGENTS; INJECTIONS, SUBCUTANEOUS; INSULIN; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE); SYRINGES;

EID: 50049106813     PISSN: 15209156     EISSN: None     Source Type: Journal    
DOI: 10.1089/dia.2008.0079     Document Type: Article

References (14)

1. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993;329:977-986.
2. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet 1998;352:837-853.
3. Santiago OM, Khutoryansky NM, Bilbo CM, Lawton SA, Kristensen CM: Accuracy and precision of the NovoPen 3 insulin delivery device after mechanical and temperature stresses. Endocr Pract 2002;8:351-355.
4. Martin JM, Llewelyn JA, Ristic S, Bates PC: Acceptability and safety of a new 3.0 ml re-usable insulin pen (HumaPen) in clinical use. Diabetes Nutr Metab 1999;12:306-309.
5. Coscelli C, Lostia S, Lunetta M, Nosari I, Coronel GA: Safety, efficacy, acceptability of a pre-filled insulin pen in diabetic patients over 60 years old. Diabetes Res Clin Pract 1995;28:173-177.
6. Roe MJ, Ignaut D, Miyakawa T, Hultman C: Dose accuracy testing of the Humalog/Humulin insulin pen device. Diabetes Technol Ther 2001;3:623-629.
7. Korytkowski M, Bell D, Jacobsen C, Suwannasari R: A multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus. Clin Ther 2003;25:2836-2848.
8. Kadiri A, Chraibi A, Marouan F, Ababou MR, el Guermai N, Wadjinny A, Kerfati A, Douiri M, Bensouda JD, Belkhadir J, Arvanitis Y: Comparison of NovoPen 3 and syringes/vials in the acceptance of insulin therapy in NIDDM patients with secondary failure to oral hypoglycaemic agents. Diabetes Res Clin Pract 1998;41:15-23.
9. Lteif AN, Schwenk WF: Accuracy of pen injectors versus insulin syringes in children with type 1 diabetes. Diabetes Care 1999;22:137-140.
10. Keith K, Nicholson D, Rogers D: Accuracy and precision of low-dose insulin administration using syringes, pen injectors, and a pump. Clin Pediatr (Phila) 2004;43:69-74.
11. Clarke A, Spollett G: Dose accuracy and injection force dynamics of a novel disposable insulin pen. Expert Opin Drug Deliv 2007;4:165-174.
12. Hermanns N, Kulzer B, Krichbaum M, Haak T: High dose-accuracy of LANTUS® SoloStar® and APIDRA® SoloStar® disposable insulin pens [abstract]. Poster presentation at the 43rd Annual Meeting of the German Diabetes Society (Deutsche Diabetes-Gesellschaft), Munich, April 30- May 3 2008.
13. Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators: The Treat-to-Target Trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care 2003;26:3080-3086.
14. International Organization for Standardization: Pen Injectors for Medical Use - Part 1: Pen Injectors - Requirements and Test Methods. ISO 11608-1. Geneva: International Organization for Standardization, 2000. Available at: http://www.iso.org (last accessed March 25, 2008).