Efficacy, safety and acceptability of the new pen needle 34G × 3.5 mm: a crossover randomized non-inferiority trial; AGO 02 study.
OBJECTIVE
Insulin injection aspects, such as fear of injection and pain, directly affect glycemic control, patient adherence and quality of life. Use of thinner and shorter needles could increase acceptance of injections. The aim of the study is to evaluate the non-inferiority of the new 34G × 3.5 mm needle compared to a 32G × 4 mm in patients with diabetes treated with insulin.


METHODS
This is an open, randomized, two-period crossover, non-inferiority trial. Every treatment period lasted 3 weeks. Patients with type 1 or type 2 diabetes, treated with multiple daily insulin injections, were randomly assigned to receive a 34G × 3.5 mm or a 32G × 4 mm pen needle. The primary endpoint was the non-inferiority of the 34G × 3.5 mm in comparison with the 32G × 4 mm pen needle in terms of percentage absolute change of blood fructosamine (% |ΔFru|), using a non-inferiority margin of 20%.


RESULTS
Overall 77 patients were randomized and 73 completed the study. Patients characteristics were: 52% male, 80.5% affected by type 1 diabetes, mean age 52 years (±14.6), mean BMI 24.5 kg/m2 (±5.6), HbA1c 8% (±1.1) and baseline fructosamine level 350 µmol/l (±84). Mean fructosamine levels increased by 0.56 µmol/l with the 34G needle, while a reduction of 7.29 μmol/l was documented with the 32G needle. The difference between the two groups (7.84 μmol/l) was not statistically significant (p = .27). The % |ΔFru| between the two groups was 7.55% (95% CI 5.67-9.44), meeting the non-inferiority criterion. Glycemic variability, expressed as standard deviation of fasting blood glucose and post-prandial glucose, was not different between the two treatment groups (p = .63 and p = .77, respectively).


CONCLUSIONS
The 34G × 3.5 mm needle was non-inferior to the 32G × 4 mm needle regarding fructosamine levels and glycemic variability supporting the suitability of the 34G × 3.5 mm needle for insulin injection in patients with diabetes.


CLINICAL TRIAL REGISTRATION
NCT02690467.
['De Berardis|Giorgia|G|', 'Scardapane|Marco|M|', 'Lucisano|Giuseppe|G|', 'Abbruzzese|Santina|S|', 'Bossi|Antonio Carlo|AC|', 'Cipponeri|Elisa|E|', "D'Angelo|Paola|P|", 'Fontana|Lucia|L|', 'Lancione|Roberta|R|', 'Marelli|Giuseppe|G|', 'Sciangula|Luigi|L|', 'Nicolucci|Antonio|A|']
D000328:Adult D000368:Aged D001786:Blood Glucose D003922:Diabetes Mellitus, Type 1 D003924:Diabetes Mellitus, Type 2 D005260:Female D006801:Humans D007004:Hypoglycemic Agents D007267:Injections D007328:Insulin D008297:Male D008875:Middle Aged D009339:Needles D010349:Patient Compliance D057240:Patient Preference D011788:Quality of Life D013594:Syringes D016896:Treatment Outcome
needle Insulin Diabetes fructosamine crossover trial