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NCT Number: NCT05125185

The Effect of USM-IAM-based Counselling

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.

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Key information

Conditions

Diabetes Type 2 on Insulin

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

About this study

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:

  • 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
  • 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.
  • 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.
  • To identify factors associated with nonadherence (before starting of intervention) among patients on insulin such as sociodemographic, SMBG and treatment factors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 18 to 65 years
  • 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

  • do not understand Malay language or illiterate
  • have severe diabetes complications such as chronic kidney disease, heart failure
  • recurrent hypoglycemia or hypoglycemia unawareness
  • body mass index (BMI) ≥ 40kg/m2

Treatment and study plan

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

Primary outcomes

  1. Change of insulin adherence score

    Time frame: 3 months

    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

  2. Change of insulin adherence score

    Time frame: 6 months

    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

  3. Change of Fasting Blood Sugar

    Time frame: 3 months

    change of FBS from baseline to 3 months

  4. Change of Fasting Blood Sugar

    Time frame: 6 months

    change of FBS from baseline to 6 months

  5. Change of HbA1c

    Time frame: 3 months

    change of HbA1c from baseline to 3 months

  6. Change of HbA1c

    Time frame: 6 months

    change of HbA1c from baseline to 6 months

  7. Change of HsCRP

    Time frame: 6 months

    change of HsCRP from baseline to 6 months

  8. Change of VCAM-1

    Time frame: 6 months

    change of baseline from baseline to 6 months

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2021
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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