Diabetic medicine : a journal of the British Diabetic Association · 2025
Marked improvement in HbA1c following introduction of biosimilar insulin to treatment regimen of children and youth with type 1 diabetes in Mali: A randomised controlled trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Besançon Stéphane, Haynes Aveni, Togo Amagara Domon, Sandy Jessica Lynn, Maniam Jayanthi, Sidibe Asa Traoré, Djéneba Sylla, de Beaufort Carine, Perolini Montserrat Castellsague, Gastaldi Giacomo, Beran David, Eigenmann Cecile, Ogle Graham David
Аннотация
AIMS: Evidence on outcomes of treating type 1 diabetes (T1D) with long-acting basal insulins in low-resourced settings is lacking. This study aimed to evaluate the impact of switching children and youth with T1D in the low-income country of Mali from human insulin via syringe to long-acting biosimilar insulin glargine delivered by reusable pens combined with short-acting insulin via syringe.
METHODS: A two-group parallel design randomised trial was conducted enrolling 260 youth aged <25 years, diagnosed with T1D for ≥12 months without prior use of analogue insulin. Youth were randomised 1:1 to either continue receiving current therapy or switch to analogue insulin. The primary outcome was HbA1c, collected at baseline and 3-monthly for 12 months.
RESULTS: Primary outcome data were available for 130 (100%) youth in the intervention group and 128 (98.5%) in the control group. Over the 12-month study period, mean HbA1c decreased from 103 to 65 mmol/mol (11.6%-8.1%) (p < 0.001) in the intervention group and from 101 to 93 mmol/mol (11.4% to 10.7%) in the control group (p < 0.01), an absolute difference of 30 mmol/mol (95% CI: -37, -24) (p < 0.001). The proportion of participants with HbA1c ≥130 mmol/mol (≥14%) decreased from 38.5% to 0% in the intervention group, versus 40.6% to 21.9% in the control group.
CONCLUSIONS: Switching to a basal-bolus insulin regimen including biosimilar glargine resulted in marked improvements in HbA1c and diabetic ketoacidosis episodes. With relevant training, resources, and support, use of long-acting analogue insulin for treating T1D in Mali was feasible and acceptable to participants and healthcare professionals.
METHODS: A two-group parallel design randomised trial was conducted enrolling 260 youth aged <25 years, diagnosed with T1D for ≥12 months without prior use of analogue insulin. Youth were randomised 1:1 to either continue receiving current therapy or switch to analogue insulin. The primary outcome was HbA1c, collected at baseline and 3-monthly for 12 months.
RESULTS: Primary outcome data were available for 130 (100%) youth in the intervention group and 128 (98.5%) in the control group. Over the 12-month study period, mean HbA1c decreased from 103 to 65 mmol/mol (11.6%-8.1%) (p < 0.001) in the intervention group and from 101 to 93 mmol/mol (11.4% to 10.7%) in the control group (p < 0.01), an absolute difference of 30 mmol/mol (95% CI: -37, -24) (p < 0.001). The proportion of participants with HbA1c ≥130 mmol/mol (≥14%) decreased from 38.5% to 0% in the intervention group, versus 40.6% to 21.9% in the control group.
CONCLUSIONS: Switching to a basal-bolus insulin regimen including biosimilar glargine resulted in marked improvements in HbA1c and diabetic ketoacidosis episodes. With relevant training, resources, and support, use of long-acting analogue insulin for treating T1D in Mali was feasible and acceptable to participants and healthcare professionals.