2008PEDIATRICSRequires access

Adolescent Use of Insulin and Patient-Controlled Analgesia Pump Technology: A 10-Year Food and Drug Administration Retrospective Study of Adverse Events

Andrea E. Scaramuzza, Dario Iafusco, Fortunato Lombardo, Ivana Rabbone, Sonia Toni, On behalf of the Italian Society of Endocrinology and Diabetology

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Abstract

To the Editor.—After reading the article by Cope et al,1 we believe even more than ever that the most important factor for successful continuous subcutaneous insulin infusion (CSII) therapy is good selection of the potential candidate to use it.In this respect, after publication of the international recommendations,2 we recently published the Italian recommendations for CSII in pediatric patients.3 Beside the general indications for starting CSII, we considered the specific indications according to patient age.3 We think that the criteria for qualifying a patient as a candidate for CSII may differ depending on age, because every period has different metabolic/social characteristics. In very young children the main risk is hypoglycemia, whereas in adolescents it is the dawn phenomenon and/or insulin resistance and the need for a more flexible lifestyle.3The conclusion of Cope et al1 that insulin pumps may be dangerous in adolescents is not supported by the evidence presented in the article, attributable to the limitations of the study, which were well described, however, in considerable detail by the authors.This could be an issue that deals more with the general challenges of being a teenager and succeeding with type 1 diabetes, regardless of insulin regimen, which underlines the importance of continued parental involvement (also mentioned specifically by the authors).To this end, in a large multicenter Italian study we have observed a CSII drop-out rate of 7% (nearly 1100 patients with CSII, aged 0–18 years [ie, 11% of the total population studied]). Adolescents represent the group in which the drop-out rate was higher (67%), showing once again that adolescence is a challenging period.Beyond patient indications, both the diabetes team and patient/family have to show specific prerequisites.3 In Italy, to start CSII it is essential that all hospitals show these characteristics and be integrated into the Italian Health Organisation. Moreover, to fulfill the most recent Italian law indications, we decided to propose an “informed therapeutic agreement” for the use of CSII between the patient and his or her family and the diabetic team3 to reinforce their motivation. As physicians involved in the care of children with diabetes (some of whom might use insulin pumps), we always recommend remaining involved in children's care, and we would suggest working together to review pump therapy periodically or as a child's situation changes. The pump itself does not hurt; it is the misuse of it that does.

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What this paper is about

To the Editor.—After reading the article by Cope et al,1 we believe even more than ever that the most important factor for successful continuous subcutaneous insulin infusion (CSII) therapy is good selection of the potential candidate to use it.In this respect, after publication of the international recommendations,2 we recently published the Italian recommendations for CSII in pediatric patients.3 Beside the general indications for starting CSII, we considered the specific indications according to patient age.3 We think that the criteria for qualifying a patient as a candidate for CSII may differ depending on age, because every period has different metabolic/social characteristics. In very young children the main risk is hypoglycemia, whereas in adolescents it is the dawn phenomenon and/or insulin resistance and the need for a more flexible lifestyle.3The conclusion of Cope et al1 that insulin pumps may be dangerous in adolescents is not supported by the evidence presented in the article, attributable to the limitations of the study, which were well described, however, in considerable detail by the authors.This could be an issue that deals more with the general challenges of being a teenager and succeeding with type 1 diabetes, regardless of insulin regimen, which underlines the importance of continued parental involvement (also mentioned specifically by the authors).To this end, in a large multicenter Italian study we have observed a CSII drop-out rate of 7% (nearly 1100 patients with CSII, aged 0–18 years [ie, 11% of the total population studied]). Adolescents represent the group in which the drop-out rate was higher (67%), showing once again that adolescence is a challenging period.Beyond patient indications, both the diabetes team and patient/family have to show specific prerequisites.3 In Italy, to start CSII it is essential that all hospitals show these characteristics and be integrated into the Italian Health Organisation. Moreover, to fulfill the most recent Italian law indications, we decided to propose an “informed therapeutic agreement” for the use of CSII between the patient and his or her family and the diabetic team3 to reinforce their motivation. As physicians involved in the care of children with diabetes (some of whom might use insulin pumps), we always recommend remaining involved in children's care, and we would suggest working together to review pump therapy periodically or as a child's situation changes. The pump itself does not hurt; it is the misuse of it that does.

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Available abstract

To the Editor.—After reading the article by Cope et al,1 we believe even more than ever that the most important factor for successful continuous subcutaneous insulin infusion (CSII) therapy is good selection of the potential candidate to use it.In this respect, after publication of the international recommendations,2 we recently published the Italian recommendations for CSII in pediatric patients.3 Beside the general indications for starting CSII, we considered the specific indications according to patient age.3 We think that the criteria for qualifying a patient as a candidate for CSII may differ depending on age, because every period has different metabolic/social characteristics. In very young children the main risk is hypoglycemia, whereas in adolescents it is the dawn phenomenon and/or insulin resistance and the need for a more flexible lifestyle.3The conclusion of Cope et al1 that insulin pumps may be dangerous in adolescents is not supported by the evidence presented in the article, attributable to the limitations of the study, which were well described, however, in considerable detail by the authors.This could be an issue that deals more with the general challenges of being a teenager and succeeding with type 1 diabetes, regardless of insulin regimen, which underlines the importance of continued parental involvement (also mentioned specifically by the authors).To this end, in a large multicenter Italian study we have observed a CSII drop-out rate of 7% (nearly 1100 patients with CSII, aged 0–18 years [ie, 11% of the total population studied]). Adolescents represent the group in which the drop-out rate was higher (67%), showing once again that adolescence is a challenging period.Beyond patient indications, both the diabetes team and patient/family have to show specific prerequisites.3 In Italy, to start CSII it is essential that all hospitals show these characteristics and be integrated into the Italian Health Organisation. Moreover, to fulfill the most recent Italian law indications, we decided to propose an “informed therapeutic agreement” for the use of CSII between the patient and his or her family and the diabetic team3 to reinforce their motivation. As physicians involved in the care of children with diabetes (some of whom might use insulin pumps), we always recommend remaining involved in children's care, and we would suggest working together to review pump therapy periodically or as a child's situation changes. The pump itself does not hurt; it is the misuse of it that does.

Key concepts: Medicine, Regimen, Hypoglycemia, Pediatrics, Insulin pump, Insulin, Adverse effect, Population

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