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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

Primary Purpose

Diabetes Type 2 on Insulin

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
Sponsored by
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Type 2 on Insulin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universiti Sains MalaysiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

current counseling

counseling using module

Arm Description

counseling by diabetic educators on insulin injection technique, hypoglycemia, SMBG and insulin dose optimization

counseling by diabetic educators on insulin injection technique, hypoglycemia, SMBG, insulin dose optimization and subtopic on nonadherence

Outcomes

Primary Outcome Measures

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
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
Change of Fasting Blood Sugar
Change of Fasting Blood Sugar
Change of HbA1c
Change of HbA1c
Change of HsCRP
Change of VCAM-1

Secondary Outcome Measures

Full Information

First Posted
October 27, 2021
Last Updated
November 17, 2021
Sponsor
Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT05125185
Brief Title
The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 2 on Insulin

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
comparing effect of counseling to insulin adherence, FBS, HbA1c, HsCRP and VCAM-1
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
current counseling
Arm Type
Active Comparator
Arm Description
counseling by diabetic educators on insulin injection technique, hypoglycemia, SMBG and insulin dose optimization
Arm Title
counseling using module
Arm Type
Experimental
Arm Description
counseling by diabetic educators on insulin injection technique, hypoglycemia, SMBG, insulin dose optimization and subtopic on nonadherence
Intervention Type
Other
Intervention Name(s)
The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
Intervention Description
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 Outcome Measure Information:
Title
Change of insulin adherence score
Description
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
Time Frame
3 months
Title
Change of insulin adherence score
Description
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
Time Frame
6 months
Title
Change of Fasting Blood Sugar
Time Frame
3 months
Title
Change of Fasting Blood Sugar
Time Frame
6 months
Title
Change of HbA1c
Time Frame
3 months
Title
Change of HbA1c
Time Frame
6 months
Title
Change of HsCRP
Time Frame
6 months
Title
Change of VCAM-1
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Universiti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
aida zainudin, MD
Phone
60179005539
Email
draidamaziha@usm.my
Phone
097676131
First Name & Middle Initial & Last Name & Degree
Wan Mohd Izani Wan Mohamed, MBChB

12. IPD Sharing Statement

Learn more about this trial

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

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