Safety and Effectiveness of Insulin Pump Therapy in Children and Adolescents With Type 1 Diabetes

Leslie P. Plotnick, MD, Loretta M. Clark, RN, BSN, CDE, Frederick L. Brancati, MD, MHS, Thomas Erlinger, MD, MPH

Disclosures

Diabetes Care. 2003;26(4) 

In This Article

Results

The population was composed primarily of Caucasians, with a mean age of 12 years. Slightly over half the population was female, and the mean duration of diabetes was 5.6 years. Table 1 shows the rate of complications by pump status. Pre- and postpump data and rate ratios (RRs) are shown for each complication and the overall complication rate. The number of hypoglycemic events was lower after pump start than before pump start (RR 0.46, 95% CI 0.21-1.01). There were 14.3 hypoglycemic events per 1,000 patient-months before pump start and 6.6 per 1,000 patient-months after pump start. There were few episodes (n = 2) of DKA (one before and one after pump start). There was no difference in ED visits before and after pump start (0.98, 0.50-1.94). There were eight superficial site infections during the entire period. All were treated with warm compresses and/or antibiotics. When all adverse events were combined, there was no difference in complications before versus after pump start (0.86, 0.51-1.45).

Figure 1 shows mean (SD) HbA1c for each time interval from 12 months before pump start, through initiation of insulin pump, to >48 months after pump start. HbA1c at pump start was significantly lower than HbA1c 6-12 months earlier (P < 0.05). HbA1c was significantly improved 3-6 months after pump start (P = 0.03). However, 6 months after pump start, there was a significant upward trend in HbA1c (P < 0.001).

Unadjusted mean (95% CI) HbA1c in 95 children and adolescents with type 1 diabetes by time since insulin pump placement. *P < 0.05 for t test compared with time of pump placement. Upward trend after pump placement was statistically significant (P < 0.01 for trend).

To determine whether this upward trend in HbA1c after pump start was a result of pump placement or a reflection of other underlying factors, we analyzed other associations with HbA1c. HbA1c was highly correlated with both duration of diabetes (Spearman’s r = 0.25, P < 0.0001) and chronological age (Spearman’s r = 0.11, P = 0.001). After adjusting for duration and age, HbA1c was lower after pump start (7.7%) than before pump start (8.1%) (Fig. 2).

Mean HbA1c (95% CI) before and after insulin pump placement after adjusting for age and duration of diabetes.

In additional analyses, we studied the association between HbA1c and several potential determinants ( Table 2 ). In a univariate analysis, age, duration of diabetes, parental involvement, and monitoring frequency (more than four times per day) were associated with HbA1c levels. Pump use was not associated with HbA1c in univariate analyses over the entire study period. However, when we included all variables in the model, pump use was associated with lower HbA1c (P < 0.001). Other factors associated with lower HbA1c in multivariate analysis included greater parental involvement, duration of diabetes, and monitoring frequency. BMI was identical before and after pump start (mean ± SE = 20.3 ± 0.3 vs. 20.2 ± 0.3, P = 0.23, after adjusting for age and sex).

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