A multicenter observational safety study in Swedish children and adolescents using insulin detemir for the treatment of type 1 diabetes

Pediatric Diabetes

Volumn 14, Issue 5, 2013, Pages 358-365

  Carlsson, Annelie ^a   Forsander, Gun ^b   Ludvigsson, Johnny ^c   Larsen, Sara ^d   Örtqvist, Eva ^e  

^a LUND UNIVERSITY HOSPITAL   (Sweden)

^b QUEEN SILVIA CHILDREN'S HOSPITAL   (Sweden)

^c LINKÖPING UNIVERSITY   (Sweden)

^d Novo Nordisk Scandinavia   (Sweden)

^e KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

Detemir; Pediatrics; Safety; Type 1 diabetes

Indexed keywords

GLUCOSE; HEMOGLOBIN A1C; INSULIN DETEMIR;

ADOLESCENT; ADULT; ARTICLE; BODY WEIGHT; CHILD; DOSE RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GLUCOSE BLOOD LEVEL; GLYCEMIC CONTROL; HUMAN; HYPOGLYCEMIA; INCIDENCE; INFANT; INJECTION SITE REACTION; INSULIN DEPENDENT DIABETES MELLITUS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NOCTURNAL HYPOGLYCEMIA; OBSERVATIONAL STUDY; OPEN STUDY; OUTCOME ASSESSMENT; PRESCHOOL CHILD; PRIORITY JOURNAL; SCHOOL CHILD; SWEDEN; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT; WEIGHT GAIN;

EID: 84881028892     PISSN: 1399543X     EISSN: 13995448     Source Type: Journal    
DOI: 10.1111/pedi.12019     Document Type: Article

References (31)

1. Nordwall M, Arnqvist HJ, Bojestig M, Ludvigsson J. Good glycemic control remains crucial in prevention of late diabetic complications - the Linkoping Diabetes Complications Study. Pediatr Diabetes 2009: 10: 168-172.
2. DCCT Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993: 329: 977-986.
3. DCCT Research Group. Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. J Pediatr 1994: 125: 177-188.
4. Bojestig M, Arnqvist HJ, Hermansson G, Karlberg BE, Ludvigsson J. Declining incidence of nephropathy in insulin-dependent diabetes mellitus. N Engl J Med 1994: 330: 15-18.
5. Nordwall M, Bojestig M, Arnqvist HJ, Ludvigsson J. Linköping Diabetes Complications Study. Declining incidence of severe retinopathy and persisting decrease of nephopathy in an unselected population of type 1 diabetes - the Linkoping Diabetes Complications Study. Diabetologia 2004: 47: 1266-1272.
6. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2diabetes(UKPDS). Lancet 1998: 352: 854-865.
7. Davis EA, Keating B, Byrne GC, Russell M, Jones TW. Hypoglycemia: incidence and clinical predictors in a large population-based sample of children and adolescents with IDDM. Diabetes Care 1997: 20: 22-25.
8. Bjørgaas MR. Cerebral effects of severe hypoglycaemia in young people with type 1 diabetes. Pediatr Diabetes 2012: 13: 100-107.
9. Ho MS, Weller NJ, Ives FJ et al. Prevalence of structural central nervous system abnormalities in early-onset type 1 diabetes mellitus. J Pediatr 2008: 153: 385-390.
10. Lunetta M, Damanti AR, Fabbri G, Lombardo M, Di Mauro M, Mughini L. Evidence by magnetic resonance imaging of cerebral alterations of atrophy type in young insulin-dependent diabetic patients. J Endocrinol Invest 1994: 17: 241-245.
11. Perros P, Deary IJ, Sellar RJ, Best JJ, Frier BM. Brain abnormalities demonstrated by magnetic resonance imaging in adult IDDM patients with and without a history of recurrent severe hypoglycemia. Diabetes Care 1997: 20: 1013-1018.
12. Ryan C, Gurtunca N, Becker D. Hypoglycemia: a complication of diabetes therapy in children. Pediatr Clin North Am 2005: 52: 1705-1733.
13. Barnard K, Thomas S, Royle P, Noyes K, Waugh N. Fear of hypoglycaemia in parents of young children with type 1 diabetes: a systematic review. BMC Pediatr 2010: 10: 50.
14. Davis NL, Bursell JD, Evans WD, Warner JT, Gregory JW. Body composition in children with type 1 diabetes in the first year after diagnosis: relationship to glycaemic control and cardiovascular risk. Arch Dis Child 2012: 97: 312-315.
15. Hanberger L, Samuelsson U, Berterö C, Ludvigsson J. The influence of structure, process, and policy on HbA1c levels in treatment of children and adolescents with type 1 diabetes. Diabetes Res Clin Pract 2012: 96: 331-338.
16. Bartley PC, Bogoev M, Larsen J, Philotheou A. Long-term efficacy and safety of insulin detemir compared to neutral protamine Hagedorn insulin in patients with type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med 2008: 25: 442-449.
17. Russell-Jones D, Bolinder J, Simpson R. Lower and more predictable fasting blood glucose and reduced risk of nocturnal hypoglycaemia with once daily insulin detemir versus NPH in subjects with type 1 diabetes. Diabetologia 2002: 45 (Suppl. 1): A51.
18. Haak T, Tiengo A, Draeger E, Suntum M, Waldhäusl W. Lower within-subject variability of fasting blood glucose and reduced weight gain with insulin detemir compared to NPH insulin in patients with type 2 diabetes. Diabetes Obes Metab 2005: 7: 56-64.
19. Vague P, Selam JL, Skeie S et al. Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart. Diabetes Care 2003: 26: 590-596.
20. Robertson KJ, Schoenle E, Gucev Z, Mordhorst L, Gall MA, Ludvigsson J. Insulin detemir compared with NPH insulin in children and adolescents with type 1 diabetes. Diabet Med 2007: 24: 27-34.
21. Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Treatment with insulin detemir or NPH insulin in children aged 2-5 yr with type 1 diabetes mellitus. Pediatr Diabetes 2011: 12: 632-641.
22. Lüddeke HJ, Sreenan S, Aczel S et al, PREDICTIVE Study Group. PREDICTIVE™ - a global, prospective observational study to evaluate insulin detemir treatment in types 1 and 2 diabetes: baseline characteristics and predictors of hypoglycaemia from the European cohort. Diabetes Obes Metab 2007: 9: 428-434.
23. Sreenan S, Virkamäki A, Zhang K, Hansen JB. PREDICTIVE study group. Switching from NPH insulin to once-daily insulin detemir in basal-bolus-treated patients with diabetes mellitus: data from the European cohort of the PREDICTIVE™ study. Int J Clin Pract 2008: 62: 1971-1980.
24. Dornhorst A, Lüddeke HJ, Honka M et al, PREDICTIVE Study Group. Safety and efficacy of insulin detemir basal-bolus therapy in type 1 diabetes patients: 14-week data from the European cohort of the PREDICTIVE study. Curr Med Res Opin 2008: 24: 369-376.
25. Karlberg J, Luo ZC, Albertsson-Wikland K. Body mass index reference values (mean and SD) for Swedish children. Acta Paediatr 2001: 90: 1427-1434.
26. Kurtoglu S, Atabek ME, Dizdarer C et al. Insulin detemir improves glycemic control and reduces hypoglycemia in children with type 1 diabetes: findings from the Turkish cohort of the PREDICTIVE™ observational study. Pediatr Diabetes 2009: 10: 401-407.
27. Silverstein J, Klingensmith G, Copeland K et al, American Diabetes Association. Care of children and adolescents with type 1 diabetes: a statement of the American Diabetes Association. Diabetes Care 2005: 28: 186-212.
28. Global IDF/ISPAD guideline for diabetes in childhood and adolescence. 2011 (available from http://www.ispad.org/NewsFiles/IDF-ISPAD_Diabetes_in_Childhood_and%20Adolescence_Guidelines_2011.pdf). Accessed on 14 November 2012.
29. Rosenstock J, Davies M, Home PD, Jarsen J. A randomised, 52-week, treat-to-target trial comparing insulin detemir with insulin glargine when administered as an add-on to glucose-lowering drugs in insulin-naïve people with type 2 diabetes. Diabetologia 2008: 51: 408-416.
30. Thalange N, Bereket A, Larsen J, Hiort LC, Peterkova V. Insulin analogues in children with type 1 diabetes: a 52-week randomized clinical trial. Diabet Med 2013: 30: 216-225.
31. Cryer PE. Hypoglycemia: the limiting factor in the glycaemic management of type 1 and type II diabetes. Diabetologia 2002: 45: 937-948.