Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2021-08-01
2022-07-30
Brief Summary
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Patients education has been showed to improved adherence. Among the 355 participants involved in the study, 82% of the patients have received consultation by diabetic educators yet their glycemic control were suboptimal. A new approaches using a module-based counseling that emphasized on adherence has been developed and the effectiveness of the counseling need to be evaluated.
Detailed Description
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Specific objective:
1. To determine within group changes and between group differences of insulin adherence score (using IAQDM) between patients in intervention and control group at baseline, 3rd month and 6th month
2. To determine within group changes and between group differences of FBS and HbA1c between patients in intervention and control group at baseline, 3rd month and 6th month.
3. To determine within group changes and between group differences of HsCRP and VCAM-1 between patients in intervention and control group at baseline, 3rd month and 6th month.
4. To identify factors associated with nonadherence (before starting of intervention) among patients on insulin such as sociodemographic, SMBG and treatment factors.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Standard Counseling
Trained diabetic educators educate patients using flip charts produced based on Malaysian Diabetes educators' manuals, insulin pen models and handouts. All patients were given SMBG diaries and encouraged to titrate their insulin dose based on SMBG
The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
To study the effect of counseling using USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in improving Insulin Adherence, Glycemic Control and Inflammation
USM-IAM- based counseling
Trained diabetes educators counselled patients using the USM Insulin adherence module. Each patient was given the module so that they could freely refer to it when necessary. The module contains all information from standard counseling, with additional info on the definition of insulin non-adherence, causes of non-adherence, measures to overcome non-adherence and fasting safely with insulin. All patients were given SMBG diaries and encouraged to titrate their insulin dose based on SMBG
The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
To study the effect of counseling using USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in improving Insulin Adherence, Glycemic Control and Inflammation
Interventions
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The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
To study the effect of counseling using USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in improving Insulin Adherence, Glycemic Control and Inflammation
Eligibility Criteria
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Inclusion Criteria
* have been diagnosed with Type 2 Diabetes Mellitus
* Patients treated with insulin injections for at least 1 year on either basal insulin, basal plus prandial or basal bolus insulin
* HbA1c between 8 % and 15%
Exclusion Criteria
* have severe diabetes complications such as chronic kidney disease, heart failure
* recurrent hypoglycemia or hypoglycemia unawareness
* body mass index (BMI) ≥ 40kg/m2
18 Years
65 Years
ALL
No
Sponsors
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Universiti Sains Malaysia
OTHER
Responsible Party
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Aida Maziha Binti Zainudin
Principal Investigator
Principal Investigators
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Aida Maziha Zainudin
Role: PRINCIPAL_INVESTIGATOR
Universiti Sains Malaysia
Locations
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Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia
Countries
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References
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Zainudin AM, Rasool AHG, Yaacob NM, Muhamad R, Mohamed WMIW. The effect of USM-IAM-based counselling vs standard counselling on insulin adherence, FBS and HbA1c among patients with uncontrolled type 2 diabetes mellitus (T2DM): a randomised controlled trial. BMC Endocr Disord. 2024 Jul 18;24(1):118. doi: 10.1186/s12902-024-01577-6.
Other Identifiers
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304/PPSP/6315140
Identifier Type: -
Identifier Source: org_study_id