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

NCT04736225 | Completed

• 1 other identifier: CCYCH-099034
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type2 Diabetes

Keywords

Blood Glucose Self-Monitoring; Type 2 Diabetes Mellitus; Self Efficacy; Self Care,

Outcome Measures

Primary Outcomes (1)

• HbA1C

  HbA1c was measured by a 3cc venous blood sample was and analyzed with the Tosoh G8 HPLC Analyzer.

  six-month follow-up

Secondary Outcomes (2)

• self-efficacy

  six-month follow-up

• self-care behavior

  six-month follow-up

Study Arms (2)

ISTE Group

EXPERIMENTAL

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

Other: Insulin Self-Titration Education Program

Non-ISTE Group

PLACEBO COMPARATOR

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.

Other: Insulin Self-Titration Education Program

Interventions

Insulin Self-Titration Education Program 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.

ISTE Group; Non-ISTE Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• non

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Chiayi Christian Hospital: collaborator

Related Publications (3)

• Davies MJ, D'Alessio DA, Fradkin J, Kernan WN, Mathieu C, Mingrone G, Rossing P, Tsapas A, Wexler DJ, Buse JB. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2018 Dec;41(12):2669-2701. doi: 10.2337/dci18-0033. Epub 2018 Oct 4.

  PMID: 30291106 BACKGROUND

• Tomah S, Mahmoud N, Mottalib A, Pober DM, Tasabehji MW, Ashrafzadeh S, Hamdy O. Frequency of self-monitoring of blood glucose in relation to weight loss and A1C during intensive multidisciplinary weight management in patients with type 2 diabetes and obesity. BMJ Open Diabetes Res Care. 2019 Jul 29;7(1):e000659. doi: 10.1136/bmjdrc-2019-000659. eCollection 2019.

  PMID: 31413841 RESULT

• Misra A, Patel M, Agarwal P, Lodha S, Tandon N, Magdum M, Yajnik C, Ghosh R, Walekar A. Effectiveness and Safety of Physician-Led Versus Patient-Led Titration of Insulin Glargine in Indian Patients with Type 2 Diabetes Mellitus: A Subanalysis of the Asian Treat to Target Lantus Study (ATLAS). Diabetes Technol Ther. 2019 Nov;21(11):656-664. doi: 10.1089/dia.2019.0037. Epub 2019 Aug 9.

  PMID: 31335198 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tsae-Jyy Wang

  National Taipei University of Nursing and Health Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: June 1, 2010
• Primary Completion: July 30, 2011
• Study Completion: July 30, 2011
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share