Continuous Subcutaneous Infusion Pump Research Articles

Epidemiology of skin event rates among users of pumps for the subcutaneous administration of drugs for chronic conditions

Objective To provide the epidemiology of skin events occurring during long-term administration of medications delivered by continuous subcutaneous infusion pump (CSIP) systems as background rates for the development of novel CSIP treatments to use in community-based settings. Methods Using a United Kingdom general practice database, we conducted a study to assess the rates of skin events among new users of apomorphine and insulin delivered by CSIP in patients with Parkinson’s disease or diabetes, respectively. Skin events included skin infections, skin nodules/localized swelling, dermatitis/eczema, urticaria/erythema, and rash/other non-specific skin eruptions. Results Five hundred and fifty-seven adults (age 30+) were included in this descriptive cohort. The median duration of CSIP use was 17 months among 255 apomorphine users and 41 months among 302 insulin users. By 60 months, ∼40% of both cohorts experienced skin events. Repeated skin events occurred in 11% of the apomorphine cohort and 14% of the insulin cohort at any time during follow-up. The overall skin event rate in the apomorphine cohort was 17 per 1000 person-months (PM) and 13 per 1000 PM in the insulin cohort. The most common skin events in both cohorts were infection and rash/unspecified skin eruptions. The highest rates of skin events occurred soon after apomorphine CSIP initiation (36 per 1000 PM in weeks 1–2 and 50 per 1000 PM in weeks 3–4), with lower rates after 4 weeks. Insulin CSIP users’ skin event rates were consistent over the treatment duration. Conclusions Clinically important skin events are common during long-term administration of medications by CSIP.

Insulin aspart for the treatment of Type 2 diabetes

SUMMARY Insulin aspart is a rapid-acting insulin analog and is approved for use in Type 1, Type 2 and gestational diabetes. Following the subcutaneous injection, it more closely mimics the physiological release of insulin in the human body with a faster onset and shorter duration of action. It also offers several advantages like flexibility in mealtime administration, better glycemic control in the form of superior control of postprandial glucose excursion and less nocturnal hypoglycemia as compared with regular human insulin. It is safe to use in patients with renal and hepatic impairment and is approved for use in pregnancy, in children above 2 years of age, in continuous subcutaneous infusion pumps and can be used intravenously in hospital settings.

Equal Metabolic Control but Superior Caregiver Treatment Satisfaction with Insulin Aspart in Preschool Children

The aim of this study was to compare the metabolic outcomes, safety, and caregiver treatment satisfaction of basal-bolus multiple daily injection (MDI) therapy with mealtime insulin aspart (IAsp) or human insulin (HI) (both with basal NPH insulin), or of continuous subcutaneous infusion (CSII) with IAsp in preschool-age children with type 1 diabetes mellitus. After a 3-week HI MDI run-in, 61 children <7 years old were randomized to IAsp MDI or HI MDI or allocated to IAsp CSII for 26 weeks. Efficacy measures were glycated hemoglobin (A1C) and overall metabolic control at study end point. Safety evaluation included hypoglycemia and adverse events. Caregiver treatment satisfaction was evaluated using a World Health Organization questionnaire with 7-point scale answers. A1C level and overall metabolic control remained unchanged in all groups. Minor hypoglycemic episodes were equivalent between groups; few major hypoglycemic events occurred. Caregivers of children receiving IAsp CSII documented a greater increase in treatment satisfaction total scores (P = 0.04 vs. HI MDI and IAsp MDI group) and expressed satisfaction with the frequency of hypoglycemic events. After 26 weeks of treatment with IAsp CSII, IAsp MDI, or HI MDI, all metabolic control parameters remained unchanged and equivalent. Caregiver treatment satisfaction was higher in parents who chose IAsp CSII pump therapy for their children.

Insulin pump therapy vs. multiple daily injections in obese Type 2 diabetic patients

To compare the efficacy of insulin pump treatment with multiple daily injections in the treatment of poorly controlled obese Type 2 diabetic patients already receiving two or more daily injections of insulin plus metformin. Forty obese Type 2 diabetic subjects (using insulin) were randomized to treatment with continuous subcutaneous infusion pump (CSII) (Minimed) or multiple daily insulin injections (MDI). At the end of the first 18-week treatment period, patients underwent a 12-week washout period during which they were treated with MDI plus metformin. They were then crossed-over to the other treatment for an 18-week follow-up period. Patients performed 4-point daily self blood-glucose monitoring (SBGM) on a regular basis and 7-point monitoring prior to visits 2, 8, 10 and 16. A subset of patients underwent continuous glucose monitoring using the Minimed(R) continuous glucose monitoring system (CGMS) at visits 2, 8, 10 and 16. A standard meal test was performed in which serum glucose was tested at fasting and once each hour for 6 h following a test meal. Glucose levels were plotted against time and the area under the curve (AUC) was calculated. HbA(1c), weight, daily insulin dose and hypoglycaemic episodes were recorded. In obese Type 2 diabetic patients already treated with insulin, treatment with CSII significantly reduced HbA(1c) levels compared with treatment with MDI. An additional CSII treatment benefit was demonstrated by reduced meal-test glucose AUC. Initial reduction of daily insulin requirement observed in CSII-treated subjects during the first treatment period was attributable to a period effect and did not persist over time. In the intent-to-treat analysis, CSII appeared to be superior to MDI in reducing HbA(1c) and glucose AUC values without significant change in weight or insulin dose in obese, uncontrolled, insulin-treated Type 2 diabetic subjects.