BACKGROUND: To determine whether a Web-based diabetes case management program based in an electronic medical record can improve glycemic control (primary outcome) and diabetes-specific self-efficacy (secondary outcome) in adults with type 1 diabetes, a pilot randomized controlled trial was conducted. METHODS: A 12-month randomized trial tested a Web-based case management programin a diabetes specialty clinic. Patients 21-49 years old with type 1 diabetes receiving multiple daily injections with insulin glargine and rapid-acting analogs who had a recent A1C >7.0% were eligible for inclusion. Participants were randomized to receive either (1) usual care plus the nurse-practitioner-aided Web-based case management program (intervention) or (2) usual clinic care alone (control). We compared patients in the two study arms for changes in A1C and self-efficacy measured with the Diabetes Empowerment Scale. RESULTS: A total of 77 patients were recruited from the diabetes clinic and enrolled in the trial. The mean baseline A1C among study participants was 8.0%. We observed a nonsignificant decrease in average A1C (-0.48; 95% confidence interval -1.22 to 0.27; P = 0.160) in the intervention group compared to the usual care group. The intervention group had a significant increase in diabetes-related self-efficacy compared to usual care (group difference of 0.30; 95% confidence interval 0.01 to 0.59; P = 0.04). CONCLUSIONS: Use of a Web-based case management program was associated with a beneficial treatment effect on self-efficacy, but change in glycemic control did not reach statistical significance in this trial of patients with moderately poorly controlled type 1 diabetes. Larger studies may be necessary to further clarify the intervention's impact on health outcomes.
RCT Entities:
BACKGROUND: To determine whether a Web-based diabetes case management program based in an electronic medical record can improve glycemic control (primary outcome) and diabetes-specific self-efficacy (secondary outcome) in adults with type 1 diabetes, a pilot randomized controlled trial was conducted. METHODS: A 12-month randomized trial tested a Web-based case management program in a diabetes specialty clinic. Patients 21-49 years old with type 1 diabetes receiving multiple daily injections with insulin glargine and rapid-acting analogs who had a recent A1C >7.0% were eligible for inclusion. Participants were randomized to receive either (1) usual care plus the nurse-practitioner-aided Web-based case management program (intervention) or (2) usual clinic care alone (control). We compared patients in the two study arms for changes in A1C and self-efficacy measured with the Diabetes Empowerment Scale. RESULTS: A total of 77 patients were recruited from the diabetes clinic and enrolled in the trial. The mean baseline A1C among study participants was 8.0%. We observed a nonsignificant decrease in average A1C (-0.48; 95% confidence interval -1.22 to 0.27; P = 0.160) in the intervention group compared to the usual care group. The intervention group had a significant increase in diabetes-related self-efficacy compared to usual care (group difference of 0.30; 95% confidence interval 0.01 to 0.59; P = 0.04). CONCLUSIONS: Use of a Web-based case management program was associated with a beneficial treatment effect on self-efficacy, but change in glycemic control did not reach statistical significance in this trial of patients with moderately poorly controlled type 1 diabetes. Larger studies may be necessary to further clarify the intervention's impact on health outcomes.
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