Objectives: Degludec (IDeg) seems to improve glycemic control and to prevent hypoglycemia, respect to glargine (IGlar), in patients with type 1 diabetes (T1D). Few data have been published on IDeg effects in childhood. The aim of our study was to assess 1-year efficacy and safety of IDeg as a part of a basal-bolus (BB) therapy in children and adolescents with T1D. Methods: Forty patients (12.34.55 yrs; 24 males; 19 prepubertal; T1D duration 5.353.78 yrs; IGlar treatment by at least 1 year) were switched to once-daily IDeg because of HbA1c >7.5% or pain at IGlar injection. Insulin dose [IGlar or IDeg plus short-acting/regular at mealtime (MT)], HbA1c, FPG, BMI z-score, and severe hypoglycaemia rates were collected at baseline (T0), 3-months (T1), 6-months (T2), and 12-months (T3) after IDeg was started. Results: The switch from IGlar to IDeg allowed a longitudinal decreased of BB dose (median Δ% -3.28 at T0, -5.02 at T1, -5.36 at T2, and -4.26 at T3; ANOVA Chi Sqr.=10.4, p=0.033) mainly due to the reduction of MT dose (median Δ% -0.00 at T0, -6.06 at T1, -5.90 at T2, and -10.7 at T3; ANOVA Chi Sqr.=18.7, p< 0.001). IDeg did not significantly reduced HbA1c levels. However, in patients with HbA1c >7.5% at T0 (21 subjects) we found a longitudinal decrease in HbA1c values from 8.4% to 7.8 at T1 (p=0.005), 7.9 at T2 (p=0.031), and 8.0 at T3 (p=0.086). Moreover, 8 out 21 had HbA1c < 7.5% at T3. FPG improved by 9.5% at T2 and 3.3% at T3. BMI z-score did not change and no episode of severe hypoglycaemia was reported. Conclusions: IDeg seems to improve the glycemic control than therapy with IGlar, mainly in patients with poor glycemic control. Our results in children and adolescents suggest that the dose of IDeg should not be reduced and the MT bolus insulin appropriate replacement doses should be lowered by 11% for patients who previously received IGlar. IDeg might be considered a useful and well tolerated basal insulin also in childhood.
A 1-year long-term study on efficacy and safety of degludec in children and adolescents with type 1 diabetes / Iughetti, L.; Suprani, T.; Bruzzi, P.; Graziani, V.; Maltoni, G.; Zucchini, S.; Predieri, B.. - In: PEDIATRIC DIABETES. - ISSN 1399-5448. - 18:Supplement S25(2017), pp. 106-107. (Intervento presentato al convegno The 43rd Annual Meeting of the International Society for Pediatric and Adolescent Diabetes (ISPAD) tenutosi a Innsbruck nel 18–21 October 2017).
A 1-year long-term study on efficacy and safety of degludec in children and adolescents with type 1 diabetes
L. Iughetti;P. Bruzzi;B. Predieri
2017
Abstract
Objectives: Degludec (IDeg) seems to improve glycemic control and to prevent hypoglycemia, respect to glargine (IGlar), in patients with type 1 diabetes (T1D). Few data have been published on IDeg effects in childhood. The aim of our study was to assess 1-year efficacy and safety of IDeg as a part of a basal-bolus (BB) therapy in children and adolescents with T1D. Methods: Forty patients (12.34.55 yrs; 24 males; 19 prepubertal; T1D duration 5.353.78 yrs; IGlar treatment by at least 1 year) were switched to once-daily IDeg because of HbA1c >7.5% or pain at IGlar injection. Insulin dose [IGlar or IDeg plus short-acting/regular at mealtime (MT)], HbA1c, FPG, BMI z-score, and severe hypoglycaemia rates were collected at baseline (T0), 3-months (T1), 6-months (T2), and 12-months (T3) after IDeg was started. Results: The switch from IGlar to IDeg allowed a longitudinal decreased of BB dose (median Δ% -3.28 at T0, -5.02 at T1, -5.36 at T2, and -4.26 at T3; ANOVA Chi Sqr.=10.4, p=0.033) mainly due to the reduction of MT dose (median Δ% -0.00 at T0, -6.06 at T1, -5.90 at T2, and -10.7 at T3; ANOVA Chi Sqr.=18.7, p< 0.001). IDeg did not significantly reduced HbA1c levels. However, in patients with HbA1c >7.5% at T0 (21 subjects) we found a longitudinal decrease in HbA1c values from 8.4% to 7.8 at T1 (p=0.005), 7.9 at T2 (p=0.031), and 8.0 at T3 (p=0.086). Moreover, 8 out 21 had HbA1c < 7.5% at T3. FPG improved by 9.5% at T2 and 3.3% at T3. BMI z-score did not change and no episode of severe hypoglycaemia was reported. Conclusions: IDeg seems to improve the glycemic control than therapy with IGlar, mainly in patients with poor glycemic control. Our results in children and adolescents suggest that the dose of IDeg should not be reduced and the MT bolus insulin appropriate replacement doses should be lowered by 11% for patients who previously received IGlar. IDeg might be considered a useful and well tolerated basal insulin also in childhood.
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