Mortality among diabetic patients using continuous subcutaneous insulin-infusion pumps

Area of Science:

• Endocrinology
• Medical Device Safety
• Diabetes Management

Background:

• Concerns exist regarding mortality rates among diabetic patients using continuous subcutaneous insulin-infusion pumps.
• Previous data on pump-related deaths were insufficient to assess overall mortality risk.

Purpose of the Study:

• To investigate whether the number of deaths among diabetic patients using insulin pumps was excessive compared to conventionally treated patients.
• To identify potential risk factors associated with mortality in insulin pump users.

Main Methods:

• Retrospective analysis of deaths among an estimated 3500 diabetic patients using insulin pumps in the US by October 1982.
• Comparison of observed deaths to expected mortality rates based on age-specific death rates for Type I diabetes patients on conventional therapy.
• Review of causes of death and patient comorbidities.

Main Results:

• 35 deaths were identified among insulin pump users.
• The observed mortality rate was not significantly higher than the expected rate for conventionally treated Type I diabetic patients.
• Two deaths were linked to device malfunction and catheter site infection (abscess).
• Patients who died frequently had autonomic neuropathy (66%) and renal disease (39% with creatinine >5 mg/dL).

Conclusions:

• Continuous subcutaneous insulin-infusion pump therapy is not associated with excess mortality in the diabetic population.
• Diabetic patients with autonomic neuropathy and renal disease may be at increased risk when using insulin pumps.
• Physician vigilance in patient selection for insulin pump therapy is crucial.