Comparative glycemic control, safety and patient ratings for a new 4 mm x 32G insulin pen needle in adults with diabetes.
Curr Med Res Opin
; 26(6): 1531-41, 2010 Jun.
Article
em En
| MEDLINE
| ID: mdl-20429832
ABSTRACT
OBJECTIVE:
Pen needles (PN) for subcutaneous insulin therapy have become smaller; 5 mm PNs are now the shortest in use. We evaluated the safety, efficacy and patient ratings of a new 4 mm x 32 gauge (G) PN. RESEARCH DESIGN ANDMETHODS:
Subjects with type 1 and type 2 diabetes and HbA1c 5.5% to 9.5% participated in a randomized non-inferiority cross-over trial, at four U.S. centers. Subjects used 4 mm x 32G PNs and either 5 mm x 31G PNs (4/5 mm) or 8 mm x 31G PNs (4/8 mm) in two, 3-week treatment periods; order of needle use was controlled. Subjects were either 'low dose' or 'regular dose' users (highest single insulin doseRESULTS:
Of 173 subjects randomized, 168 completed the study, and 163 were included in the fructosamine analyses--83 and 80 in the 4/5 mm and 4/8 mm groups, respectively. Subjects were 56% male, mean 52.6 yrs, 63% type 2. Baseline HbA1c = 7.5 +/- 1.0% and fructosamine 301 +/- 55.1 micromol/L. Mean % |Delta Fru| was 4.9% (95% CI 3.8, 6.0) and 5.5% (4.5, 6.4), respectively, for the 4/5 mm and 4/8 mm groups, meeting glycemic equivalence criteria; results were similar in both dose groups. The median |Delta Fru| was 11.0 micromol/L (8.0, 13.0) and 13.5 micromol/L (9.8, 18.0) for the 4/5 mm and 4/8 mm groups, respectively. Unexplained, severe hypo- and hyperglycemic episodes were infrequent and not different between PNs. The 4 mm PN was rated significantly less painful and preferred by approximately 2/3 of subjects (p < 0.01). All three PNs had similar reported injection site leakage.LIMITATIONS:
The study was of relatively short duration, in adults in the U.S. Further trials in other patients (e.g., GLP-1 users, pediatrics, obese) should be performed.CONCLUSIONS:
The 4 mm x 32G PN provided equivalent glycemic control compared to 31G, 5 mm and 8 mm PNs with reduced pain, no difference in insulin leakage and was preferred by patients.
Texto completo:
1
Coleções:
01-internacional
Contexto em Saúde:
1_ASSA2030
/
2_ODS3
Base de dados:
MEDLINE
Assunto principal:
Injeções Intradérmicas
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Índice Glicêmico
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Diabetes Mellitus Tipo 1
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Hipoglicemiantes
/
Insulina
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
Limite:
Adolescent
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Adult
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Aged
/
Female
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Humans
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Male
/
Middle aged
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Curr Med Res Opin
Ano de publicação:
2010
Tipo de documento:
Article