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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 30, 2021
Sponsor:
Information provided by (Responsible Party):
Aida Maziha Binti Zainudin, Universiti Sains Malaysia

Tracking Information
First Submitted Date  ICMJE October 27, 2021
First Posted Date  ICMJE November 18, 2021
Last Update Posted Date November 30, 2021
Actual Study Start Date  ICMJE August 1, 2021
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2021)
  • Change of insulin adherence score [ Time Frame: 3 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
  • 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
  • Change of Fasting Blood Sugar [ Time Frame: 3 months ]
  • Change of Fasting Blood Sugar [ Time Frame: 6 months ]
  • Change of HbA1c [ Time Frame: 3 months ]
  • Change of HbA1c [ Time Frame: 6 months ]
  • Change of HsCRP [ Time Frame: 6 months ]
  • Change of VCAM-1 [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 7, 2021)
  • Change of insulin adherence score [ Time Frame: 3 months ]
  • Change of insulin adherence score [ Time Frame: 6 months ]
  • Change of Fasting Blood Sugar [ Time Frame: 3 months ]
  • Change of Fasting Blood Sugar [ Time Frame: 6 months ]
  • Change of HbA1c [ Time Frame: 3 months ]
  • Change of HbA1c [ Time Frame: 6 months ]
  • Change of HsCRP [ Time Frame: 6 months ]
  • Change of VCAM-1 [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
Official Title  ICMJE The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Diabetes Type 2 on Insulin
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: current counseling
    counseling by diabetic educators on insulin injection technique, hypoglycemia, SMBG and insulin dose optimization
    Intervention: Other: The Effectiveness of 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
    Intervention: Other: The Effectiveness of USM-Insulin Adherence Module (U-IAM) for Type 2 Diabetes in Improving Insulin Adherence, Glycemic Control and Inflammation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 7, 2021)
148
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05125185
Other Study ID Numbers  ICMJE 304/PPSP/6315140
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aida Maziha Binti Zainudin, Universiti Sains Malaysia
Study Sponsor  ICMJE Universiti Sains Malaysia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universiti Sains Malaysia
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP