The Effect of USM-IAM-based Counselling

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Type 2 on Insulin
• Intervention / Treatment: Other: The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation

Detailed Description

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:

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Kelantan
    • Kubang Kerian, Kelantan, Malaysia, 16150
      • Hospital Universiti Sains Malaysia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Other: 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
Experimental: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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
Change of VCAM-1	change of baseline from baseline to 6 months	6 months

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: Aida Maziha Zainudin, Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 7, 2021
• First Posted (Actual): November 18, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 304/PPSP/6315140

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No