Type2 Diabetes Clinical Trial
— ISTEOfficial title:
Effects of the Insulin Self-titration Education on Glycemic Control in Type 2 Diabetes Mellitus Patients: A Quasi-Experimental Study
NCT number | NCT04736225 |
Other study ID # | CCYCH-099034 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2010 |
Est. completion date | July 30, 2011 |
Verified date | February 2021 |
Source | National Taipei University of Nursing and Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 30, 2011 |
Est. primary completion date | July 30, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 Exclusion Criteria: - non |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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National Taipei University of Nursing and Health Sciences | Chiayi Christian Hospital |
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. — View Citation
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 — View Citation
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 obes — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1C | HbA1c was measured by a 3cc venous blood sample was and analyzed with the Tosoh G8 HPLC Analyzer. | six-month follow-up | |
Secondary | self-efficacy | The Chinese version of the Insulin Management Diabetes Self-Efficacy Scale (IMDSES) was used to assess a participant's degree of confidence in the ability of self-controlled diabetes. The 28-item scale includes six subscales: general self-efficacy, dietary self-efficacy, insulin self-efficacy, blood glucose monitoring self-efficacy, exercise self-efficacy, and foot self-efficacy. Each item is rated on a scale from 0 (completely unsure) to 100 (very sure). The average score of all items represents the scale sore, with a possible range of 0 to 100. The higher the score the better the self-efficacy. In this study, the Cronbach's a of this scale was 0.89, and the Cronbach's a value of each sub-scale was between 0.69 and 0.95. | six-month follow-up | |
Secondary | self-care behavior | The Chinese version of the revised Diabetes Self-Care Scale (DSC) was used to measure a participant's self-care behavior. The 28-item scale includes six subscales: general self-care, self-care for diet, self-care for insulin adjustment, self-care for blood glucose monitoring, self-care for exercise, and self-care for the feet. Each item is rated on a scale from 0 (not done at all) to 100 (completely done). The average score of all items represents the scale score, with a possible range of 0 to 100. The higher the score the better the self-care behavior. In this study, the Cronbach's a of this scale was 0.89, and the Cronbach's a value of each subscale was between 0.69 and 0.86. | six-month follow-up |
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