NCT04736225

Effects of the Insulin Self Titration Education for Type 2 Diabetes Mellitus Patients

Effects of the Insulin Self-titration Education on Glycemic Control in Type 2 Diabetes Mellitus Patients: A Quasi-Experimental Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: National Taipei University of Nursing and Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to evaluate the effects of an insulin self-titration education program on glycemic control, self-efficacy, and self-care behaviors in patients with type 2 diabetes. The quasi-experimental design was adapted. A convenient sample of 120 patients with insulin-treated type 2 diabetes was recruited from a general hospital in Taiwan. Among them, 60 were in the insulin self-titration group, and 60 were in the comparison group. Data on glycated hemoglobin (HbA1C), self-efficacy, and self-care behavior were collected at baseline, three-month, and six-month follow-up. The study instruments included the Insulin Diabetes Management Self-Efficacy Questionnaire and Diabetes Self-Care questionnaire.

Detailed description

Sixty patients with insulin-treated type 2 diabetes were recruited as the intervention participants and enrolled in the insulin self-titration program. Sixty propensity score-matched patients treated with traditional insulin therapy without self-titration were recruited as the control participants. Data on HbA1C and hypoglycemia were collected at baseline and during follow-ups at three and six months. Data on self-efficacy and self-care were collected at the six-month follow-up using self-report questionnaires. The inclusion criteria were recruited: (1) age ≥ 18 years; (2) diagnosis of type 2 diabetes; (3) treatment with insulin injection for \> six months; (4) HbA1C \> 7.5% in the last three months; and (5) ability to communicate in Mandarin or Taiwanese. The insulin self-titration education program includes a 60-min small-group lesson, a 20-min individual instruction. Patients in the comparison group received usual care at the Diabetes Health Education Center. During a 15-min individual education, these patients were taught how to self-inject insulin and test and record their before-breakfast and before-dinner blood glucose levels daily at home Data on glycated hemoglobin (HbA1C) and the number of hypoglycemia were collected at baseline, three-month, and six-month follow-up. Data on self-efficacy and self-care were collected at the six-month follow-up, using the self-reported questionnaires. The study was approved by the institutional review board of the hospital where the data were collected. Data were analyzed by using the SPSS 21.0 software. Descriptive analyses were used to describe the research variables. Chi-Square and independent t-test were used to analyze the baseline equilibriums between the two groups. Independent t-tests were used to analyze between-group differences in HbA1C at each time point. A generalized estimating equation (GEE) was used to analyze between-group differences in HbA1C change over time. The independent t-test was used to analyze the difference between the two groups of participants in the post-testing diabetes self-efficacy and self-care.

Conditions

• Type2 Diabetes

Interventions

Type	Name	Description
OTHER	Insulin Self-Titration Education Program	The program contents of instruction included blood glucose self-monitoring, types of insulin, insulin self-administration, insulin dose titration, hyperglycemia or hypoglycemia self-management, diet, and exercise.a 20-min one-on-one training session from a nurse on how to self-titrate the insulin dose. The participants were taught to monitor their before-breakfast and before-dinner blood glucose levels at home and adjust their insulin doses accordingly.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-07-30
• Completion: 2011-07-30
• First posted: 2021-02-03
• Last updated: 2021-02-16