Continuous Subcutaneous Insulin Infusion at 25 Years

Abstract

Continuous subcutaneous insulin infusion (CSII) is used in selected type 1 diabetic subjects to achieve strict blood glucose control. A quarter of a century after its introduction, world-wide use of CSII is increasing. We review the evidence base that justifies this increase, including effectiveness compared with modern intensified insulin injection regimens and concern about possible complications. Review of controlled trials shows that, in most patients, mean blood glucose concentrations and glycated hemoglobin percentages are either slightly lower or similar on CSII versus multiple insulin injections. However, hypoglycemia is markedly less frequent than during intensive injection therapy. Ketoacidosis occurs at the same rate. Nocturnal glycemic control is improved with insulin pumps, and automatic basal rate changes help to minimize a prebreakfast blood glucose increase (the “dawn phenomenon”) often seen with injection therapy. Patients with “brittle” diabetes characterized by recurrent ketoacidosis are often not improved by CSII, although there may be exceptions. We argue that explicit clinical indications for CSII are helpful; we suggest the principal indications for health service or health insurance–funded CSII should include frequent, unpredictable hypoglycemia or a marked dawn phenomenon, which persist after attempts to improve control with intensive insulin injection regimens. In any circumstances, candidates for CSII must be motivated, willing and able to undertake pump therapy, and adequately psychologically stable. Some diabetic patients with well-defined clinical problems are likely to benefit substantially from CSII and should not be denied a trial of the treatment. Their number is relatively small, as would therefore be the demand on funds set aside for this purpose.

Insulin pump failures are still frequent: a prospective study over 6 years from 2001 to 2007

“…However, these findings were not confirmed in most subsequent studies [4,5]. It has been suggested that technological improvements and/or patient and physician vigilance has lowered this risk.…”

Declaración de la Academia Chilena de Medicina sobre el Título V de la Ley 20.850 (Ley Ricarte Soto) y su proyecto de reglamento "De los ensayos clínicos de productos farmacéuticos y elementos de uso médico"

“…La literatura médica registra, precisamente, numerosos ensayos clínicos dirigidos a comprobar el beneficio de medicamentos de alto costo para la mayoría de las patologías seleccionadas en la ley 20.850 [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22] .…”

Uso de bomba de infusão subcutânea de insulina e suas indicações

“…Diante de tantos recursos disponíveis, é importante considerar o valor e a relevância das características específicas oferecidas por diferentes modelos de bomba de insulina, a fim de se conseguir a melhor efetividade de custo (13 Segundo o mais recente posicionamento da Associação Norte-Americana de Diabetes (ADA), "todas as pessoas motivadas, que desejem ter autocontrole, devem ser consideradas candidatas ao uso da bomba de insulina" (16). Por outro lado, julga-se que ela deve ser reservada somente para pessoas com problemas especí-ficos, por exemplo, crises imprevisíveis de hipoglicemia e fenômeno do alvorecer.…”

“…Além disso, este sistema elimina a maioria dos depósitos de insulina subcutânea que existe quando se usa doses maiores de insulina NPH ou as de ação mais prolongada (19). O controle glicêmico noturno é melhorado com as bombas de insulina, e com elas é minimizado o aumento da glicemia anterior ao café-da-manhã (o fenômeno do alvorecer), observado em pacientes com DM1, tratados com injeções de insulina (16). Outra grande vantagem do uso da bomba de infusão é a da liberdade e da melhora da qualidade de vida que este equipamento oferece para pessoas com horários irregulares de trabalho e alimentação.…”