DSME or DSME + MI in T1DM on Glycemic Control

Diabetes Mellitus Clinical Trial

Official title:

A Randomized Control Trial Compare Between Diabetic Knowledge and Self-care Behaviors (DSME) With and Without Motivational Interviewing, on Glycemic Control Among Children and Adolescents With Diabetes Mellitus Type 1

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03104829
• Other study ID #: SI-DSME-MI-01
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2017
• Last updated: April 1, 2017
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: April 2017
• Source: Mahidol University
• Contact: Ornsuda Lertbannaphong, MD
• Phone: 6624197000
• Email: ornsuda110[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of diabetic knowledge and self care behavior (DSME) alone or DSME plus motivational interviewing on glycemic control among children and adolescents with DM type 1. Half of participants will receive DSME along, while the other half will receive DSME plus MI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• T1DM

• age more than 10 years old

• HbA1C more than 8%

Exclusion Criteria:

• other types of DM

• receive medications that may effect blood glucose

• mental retardation

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Behavioral:
• Motivational interviewing

Drug:
• DSME participants in this arm will receive standard care for diabetes (DSME) at the beginning of the study and 3 months later

Locations

Country	Name	City	State
Thailand	Ornsuda Lertbannaphong	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (2)

Santiprabhob J, Likitmaskul S, Kiattisakthavee P, Weerakulwattana P, Chaichanwattanakul K, Nakavachara P, Peerapatdit T, Nitiyanant W. Glycemic control and the psychosocial benefits gained by patients with type 1 diabetes mellitus attending the diabetes camp. Patient Educ Couns. 2008 Oct;73(1):60-6. doi: 10.1016/j.pec.2008.05.023. Epub 2008 Jul 7. — View Citation

Viner RM, Christie D, Taylor V, Hey S. Motivational/solution-focused intervention improves HbA1c in adolescents with Type 1 diabetes: a pilot study. Diabet Med. 2003 Sep;20(9):739-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1C		at the beginning of the study, 3 month and 6 months later
Secondary	Pre and post test scores for Diabetic knowledge		at the beginning and 6 months later
Secondary	Diabetic self-care behavior score		at the beginning and 6 months later