Diabetes Type 2 on Insulin
Conditions
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.
Interventions
OTHERThe 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
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
comparing effect of counseling to insulin adherence, FBS, HbA1c, HsCRP and VCAM-1
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of insulin adherence score | 3 months | 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 |
| Change of Fasting Blood Sugar | 3 months | change of FBS from baseline to 3 months |
| Change of HbA1c | 3 months | change of HbA1c from baseline to 3 months |
| Change of HsCRP | 6 months | change of HsCRP from baseline to 6 months |
| Change of VCAM-1 | 6 months | change of baseline from baseline to 6 months |
Countries
Malaysia
Outcome results
None listed