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According to the most current local data, the rate of patient's adherence to insulin injections is very low. A recent cross sectional study in Klinik Pakar Perubatan (KPP) Hospital Universiti Sains Malaysia (HUSM) among 355 patients with Type 2 diabetes treated with insulin showed only 19% of patients adhered to their insulin regime with the mean fasting plasma glucose of 10mmol/L and mean HbA1C of 10.0%. This condition may lead to undesirable health consequences.
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.
General objective: To determine the effect of USM-insulin adherence module (U-IAM)-based counseling on the insulin adherence, glycemic control and inflammatory markers in poorly-controlled type 2 diabetes mellitus patients on insulin therapy.
Specific objective:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Counseling | Active Comparator | 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 |
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| USM-IAM- based counseling | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of insulin adherence score | Insulin adherence will be measured using an insulin adherence questionnaire for diabetes. change from mellitus. It contains 34 questions with minimum marks of 0 and a maximum of 100 marks. The higher the marks, the higher the degree of adherence. The patient is considered to adhere if they achieved marks of equal or more than 80 | 3 months |
| Change of insulin adherence score | Insulin adherence will be measured using insulin adherence questionnaire for diabetes mellitus. it contains 34 questions with minimum marks of 0 and maximum of 100 marks. The higher the marks, the higher the degree of adherence. Patient is considered adherence if they achieved marks of equal or more than 80 | 6 months |
| Change of Fasting Blood Sugar | change of FBS from baseline to 3 months | 3 months |
| Change of Fasting Blood Sugar | change of FBS from baseline to 6 months | 6 months |
| Change of HbA1c | change of HbA1c from baseline to 3 months | 3 months |
| Change of HbA1c | change of HbA1c from baseline to 6 months | 6 months |
| Change of HsCRP | change of HsCRP from baseline to 6 months | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aida Maziha Zainudin | Universiti Sains Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universiti Sains Malaysia | Kubang Kerian | Kelantan | 16150 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39020348 | Derived | 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. |
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| ID | Term |
|---|---|
| D000085002 | Glycemic Control |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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comparing effect of counseling to insulin adherence, FBS, HbA1c, HsCRP and VCAM-1
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| Change of VCAM-1 | change of baseline from baseline to 6 months | 6 months |