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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-01

Study Completion Date

2011-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Pre-medical Consultation Diabetes Self-care Education Programme on Glycemic Control in Type 2 Diabetes

NCT04092569

Type 2 Diabetes

UNKNOWN NA

The Effectiveness of Multimedia Education for Patients With Type 2 Diabe Mellitus

NCT03728647

Type 2 Diabetes Mellitus Insulin Education

COMPLETED NA

Effects of Using Decision Cycle for Person-Centered Glycemic Management in Type 2 Diabetes

NCT06331338

Type 2 Diabetes

RECRUITING NA

The Application of the E-health Education on Shared Care Program for Patients With Type 2 Diabetes

NCT03061266

Type 2 Diabetes Mellitus

UNKNOWN NA

Impact of an Interventional Program on Self-Management

NCT05763303

Diabetes Self Management

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Type2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ISTE Group

This program includes a 60-min small-group lesson, a 20-min individual instruction. The education program's goal is to teach patients to self-titrate their insulin doses every six days to maintain their six-day average blood glucose levels \< 120 mg/dl

Group Type EXPERIMENTAL

Insulin Self-Titration Education Program

Intervention Type OTHER

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.

Non-ISTE Group

The usual care (a 15-min individual education) was giving at the Diabetes Health Education Center. They were taught how to self-inject insulin and test and record their before-breakfast and before-dinner blood glucose levels daily at home.

Group Type PLACEBO_COMPARATOR

Insulin Self-Titration Education Program

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age ≥ 18 years
* diagnosis of type 2 diabetes
* treatment with insulin injection for \> six months
* HbA1C \> 7.5% in the last three months
* ability to communicate in Mandarin or Taiwanese