Affiliation:
1. Research Institute Diabetes Academy Mergentheim, Bad Mergentheim, Germany
2. Department of Clinical Psychology and Psychotherapy, University of Bamberg, Bamberg, Germany
3. Diabetes Clinic Mergentheim, Bad Mergentheim, Germany
Abstract
OBJECTIVE
Continuous subcutaneous insulin infusion (CSII) is the most advanced form of insulin delivery, but it requires structured education to provide users with the necessary knowledge/skills and to support their motivation. Currently, no structured education program designed to provide this training has been evaluated. We developed a CSII-specific, structured education program (Insulin Pump Treatment [INPUT]) and evaluated its impact on glycemic control, behavior, and psychosocial status.
RESEARCH DESIGN AND METHODS
This was a multicenter, randomized, parallel trial with a 6-month follow-up. Eligible participants (age 16–75 years) currently were treated with insulin pump therapy. Participants were randomly assigned (1:1) to the INPUT program or to usual care using a computer-generated algorithm, with study center as the stratification factor. The primary outcome was HbA1c change from baseline to 6 months. Secondary outcomes were incidence of severe hypoglycemia and changes in behavioral and psychosocial measures.
RESULTS
Between 1 April 2016 and 26 April 2016, 268 people with diabetes and a mean duration of CSII therapy of 9.5 years were randomly assigned to the INPUT group (n = 135) or control group (n = 133). At 6 months, HbA1c improved in the INPUT group (8.33 ± 0.8 vs. 8.04 ± 0.9; P < 0.0001) but not in the control group (8.33 ± 1.0 vs. 8.27 ± 1.0; P = 0.11). The between-group difference in HbA1c reduction was significant, favoring INPUT (−0.28% vs. −0.06%, Δ −0.22%, 95% CI −0.38 to −0.06; P = 0.0029). The incidence rate ratio of severe hypoglycemia was 3.55 times higher for participants in the control group than for those in the INPUT group (95% CI 1.50–8.43; P = 0.0041).
CONCLUSIONS
The INPUT education program led to a significant improvement in glycemic control and incidence of severe hypoglycemia in insulin pump users.
Publisher
American Diabetes Association
Subject
Advanced and Specialized Nursing,Endocrinology, Diabetes and Metabolism,Internal Medicine
Cited by
31 articles.
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