Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Apr 29, 2024
Date Accepted: Aug 23, 2024
Long-term Glycemic Improvement After Home and Self-care Program (HELP) for Patients with Type 1 Diabetes: A Real-World based Cohort Study
ABSTRACT
Background:
The prevalence of type 1 diabetes (T1D) is increasing globally, and it is true that adult patients make up a much larger proportion. However, due to the nature of the disease, events of hypoglycemia and hyperglycemia occur frequently in T1D patients, making stable target blood glucose management difficult. Therefore, the development of systematic education programs that reflect the diverse characteristics of patients is being demanded both clinically and from a policy perspective.
Objective:
After periodic implementation of structured education for patients with T1D through the Home and Self-care Program (HELP), supported by the Korean government, we evaluated the program’s effects on glycemic control.
Methods:
We analyzed 119 T1D subjects older than 15 years. Nursing and nutrition education were provided separately to the subjects up to four times a year, with a physician consultation at each visit, and remote support using smartphones and a digital application was provided between sessions. Patients were followed at average intervals of 2 to 4 months for up to 24 months. The primary endpoint was the mean difference in glycated hemoglobin A1c (HbA1c) at each follow-up visit from baseline. Continuous glucose monitoring (CGM) metrics including time in target range (TIR), time below range (TBR), and coefficient of variation (CV) were also evaluated.
Results:
The mean HbA1c of study subjects was 8.62% at baseline (mean duration 10.0 years). Patients who received at least one educational session had a significant reduction in HbA1c: from 1.63 ± 2.03 (P < 0.001, after adjustment 1.69, 95% confidence interval (CI) 1.24 - 2.13) at the 1st visit to 1.23 ± 1.31 (p = 0.01, 1.28, 0.78 - 1.79) at the 8th visit. Among CGM users, the mean TIR of 70 - 180 mg/dL was at least 55.0% for 24 months. The mean TBR (70 and 54) also gradually improved to the recommended range (≤ 4% and ≤ 1%) in patients who received at least one educational session: from 6.82 ± 8.11 (after adjustment 6.85, 95% CI 4.72 - 8.98) at the 1st visit to 3.43 ± 4.37 (3.16, 1.68 - 4.64) at the 8th visit for TBR 70 (P for trend = 0.003), from 1.76 ± 3.48 (1.77, 0.78 - 2.77) at the 1st visit to 0.44 ± 0.89 (0.36, 0.04 – 0.69) at the 8th visit for TBR 54 (P for trend = 0.001).
Conclusions:
The HELP protocol for glycemic control in patients with T1D is effective, producing significant improvement immediately and long-term maintenance effects, including CGM indices.
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