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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

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ClinicalTrials.gov Identifier: NCT05125185
Recruitment Status : Recruiting
First Posted : November 18, 2021
Last Update Posted : November 18, 2021
Sponsor:
Information provided by (Responsible Party):
Aida Maziha Binti Zainudin, Universiti Sains Malaysia

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.


Condition or disease Intervention/treatment Phase
Diabetes Type 2 on Insulin Other: The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: comparing effect of counseling to insulin adherence, FBS, HbA1c, HsCRP and VCAM-1
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
Actual Study Start Date : August 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: current counseling
counseling by diabetic educators on insulin injection technique, hypoglycemia, SMBG and insulin dose optimization
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: counseling using module
counseling by diabetic educators on insulin injection technique, hypoglycemia, SMBG, insulin dose optimization and subtopic on nonadherence
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




Primary Outcome Measures :
  1. Change of insulin adherence score [ Time Frame: 3 months ]
  2. Change of insulin adherence score [ Time Frame: 6 months ]
  3. Change of Fasting Blood Sugar [ Time Frame: 3 months ]
  4. Change of Fasting Blood Sugar [ Time Frame: 6 months ]
  5. Change of HbA1c [ Time Frame: 3 months ]
  6. Change of HbA1c [ Time Frame: 6 months ]
  7. Change of HsCRP [ Time Frame: 6 months ]
  8. Change of VCAM-1 [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05125185


Locations
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Malaysia
Hospital Universiti Sains Malaysia Recruiting
Kubang Kerian, Kelantan, Malaysia, 16150
Contact: aida zainudin, MD    60179005539    draidamaziha@usm.my   
Contact    097676131      
Sub-Investigator: Wan Mohd Izani Wan Mohamed, MBChB         
Sponsors and Collaborators
Universiti Sains Malaysia
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Responsible Party: Aida Maziha Binti Zainudin, Principal Investigator, Universiti Sains Malaysia
ClinicalTrials.gov Identifier: NCT05125185    
Other Study ID Numbers: 304/PPSP/6315140
First Posted: November 18, 2021    Key Record Dates
Last Update Posted: November 18, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Inflammation
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs