Determination, Validation, and Development of Prediction Scores Related to Hypoglycemia Risk Factors Among Ambulatory Type 2 Diabetes Mellitus Patients in Bali, Indonesia.

Abstract

Background: Hypoglycemia is a complication that can disrupt the continuity of therapy for Type 2 Diabetes Mellitus (T2DM) patients. Therefore, ambulatory T2DM patients need supportive treatment to ensure the safety of their medication. Currently, health workers lack a standardized reference for assessing the risk of hypoglycemia in these patients. Therefore, this study aimed to determine, validate, and develop a prediction score of risk factors influencing hypoglycemia in T2DM patients.

Methods: The psychometric properties method was used in this study design, including item development, content validity, criterion validity, and construct validity. During the process of item development, Focus Group Discussions (FGDs) with experts were used. Known predictors were then validated through panelists' content assessment. Risk factors for hypoglycemia from item development and content validation were tested for criterion and construct validation using a case-- control method.

Results: Eight significant predictors caused hypoglycemia, including insulin use, SU use, insulin-- SU combination use, CKD, diabetic neuropathy, uncontrolled blood glucose, >5-year DM duration, and history of severe hypoglycemia, and the total score of risk factors was 24. The categories were defined as follows: scores of 0-8 as low-risk, 9-16 as moderate-risk, and 17-24 as high-risk. There was a positive linear relationship between the total score and risk category (p<0.05; r²: 0.959).

Conclusion: This risk factor and score prediction model can be used by health workers in clinical practice to predict the risk of ambulatory hypoglycemia in T2DM patients because it meets content, criterion, and construct validity.