Clinical trial NCT05125185: The Effect of USM-IAM-based Counselling
Official title: The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2 on Insulin
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparing effect of counseling to insulin adherence, FBS, HbA1c, HsCRP and VCAM-1
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of insulin adherence score
timeFrame: 3 months
measure: Change of insulin adherence score
timeFrame: 6 months
measure: Change of Fasting Blood Sugar
timeFrame: 3 months
measure: Change of Fasting Blood Sugar
timeFrame: 6 months
measure: Change of HbA1c
timeFrame: 3 months
measure: Change of HbA1c
timeFrame: 6 months
measure: Change of HsCRP
timeFrame: 6 months
measure: Change of VCAM-1
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: Aida Maziha Zainudin
role: PRINCIPAL_INVESTIGATOR
References: