OBJECTIVES

Blood glucose levels of the majority of Filipino patients with type 2 diabetes (T2D) remain uncontrolled. Insulin degludec/insulin aspart (IDegAsp) is a fixed‑ratio coformulation of the long‑acting basal insulin degludec and the rapid acting prandial insulin aspart. The realworld ARISE (A Ryzodeg® Initiation and Switch Effectiveness) study investigated clinical outcomes across six countries in people with T2D who initiated IDegAsp. This publication presents the clinical outcomes of the Filipino cohort from a subgroup analysis of the ARISE study.

METHODOLOGY

This 26-week, openlabel, noninterventional study examined outcomes in adults with T2D initiating or switching to IDegAsp (N=185) from other antidiabetic treatments per local clinical guidance.

RESULTS

Compared with the baseline, there was a significant improvement in glycated hemoglobin at the end of the study (EOS) (estimated difference [ED] −1.4 [95% confidence interval −1.7, −1.1]; P < 0.0001). Fasting plasma glucose (ED −46.1 mg/dL [−58.2, −34.0]; P < 0.0001) and body weight (ED −1.0 kg [−2.0, −0.1]; P = 0.028) were significantly reduced at EOS compared with baseline. IDegAsp was associated with a decrease in the incidence of selfreported healthcare resource utilization. Adverse events were reported in eight (4.3%) participants.

CONCLUSION

Initiating or switching to IDegAsp was associated with improved glycemic control, lower body weight, and lower HRU for people with T2D in the Philippines. No new, unexpected AEs were reported.

Human ; Insulin Aspart ; Insulin Degludec ; Diabetes Mellitus, Type 2

Objective: To determine the frequency of hypoglycemia in insulin-treated patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) in the non-interventional International Operations Hypoglycemia Assessment Tool (IO HAT) study. Methodology: This sub-analysis included Filipino patients with T1DM or T2DM, aged 18 years and older, treated with insulin for more than 12 months, who completed the two-part self-assessment questionnaires (SAQ1 and SAQ2) and patient diaries that recorded hypoglycemia during retrospective (6 months/4 weeks before baseline) and prospective period (4 weeks after baseline (ClinicalTrials.gov number: NCT02306681). Results: A total of 671 patients were enrolled and completed the SAQ1 (62 patients with T1DM and 609 patients with T2DM). Almost all patients (100% in T1DM and 99.3% in T2DM) experienced at least 1 hypoglycemic event prospectively. The incidence of any hypoglycemia was also high in the prospective period compared to retrospective period (72.6 [95% CI: 64.8, 80.9] events PPY and 43.6 [95% CI: 37.8, 49.9] events PPY; p=0.001, respectively) in T1DM patients. Conclusion Among insulin-treated patients, higher rates of hypoglycemia were reported prospectively than retrospectively. This indicates that the patients in real-life setting often under-report hypoglycemia. Patient education can help in accurate reporting and appropriate management of hypoglycemia and diabetes.
Hypoglycemia ; Philippines

Objective: To provide real-world data on hypoglycaemia incidence in patients with type 1 (T1D) or type 2 diabetes (T2D) from the Southeast Asian cohort of the International Operations Hypoglycaemia Assessment Tool (IO HAT) study. Methodology: IO HAT was a non-interventional, multicentre, 6-month retrospective and 4-week prospective study of hypoglycaemic events among insulin-treated adults with T1D or T2D, including four countries in Southeast Asia (Singapore, Philippines, Indonesia, and Bangladesh). Data were collected using a two-part self-assessment questionnaire (SAQ1 for retrospective and SAQ2 for prospective). The primary endpoint was the percentage of patients experiencing at least one hypoglycaemic event during the 4-week prospective observational period (ClinicalTrials.gov Identifier: NCT02306681). Results: A total of 2594 patients completed SAQ1. Nearly all patients reported experiencing any hypoglycaemic event in the 4-week prospective period (T1D, 100%; T2D, 97.3%), with all patients reporting higher rates in the prospective versus retrospective period. Severe hypoglycaemia was also reported higher prospectively (57.2% and 76.9%) than retrospectively (33.9% and 12.2%) in both T1D and T2D, respectively. Nocturnal hypoglycaemia was reported higher retrospectively than prospectively. Conclusion Incidence of any and severe hypoglycaemia in the Southeast Asian cohort of IO HAT was higher prospectively versus retrospectively, suggesting hypoglycaemia has previously been under-reported in this region.
Insulin

Introduction: Hazards of hypoglycemia include accidents, cardiovascular events, neurologic damage, and impaired hypoglycemia awareness (IHA) which presents as inability to perceive and respond to hypoglycemic warning symptoms. Objective: This study aimed to develop the first questionnaire evaluating IHA adapted from Clarke Hypoglycemia Index (CHI) and validated among adult Filipino patients with Type 2 Diabetes Mellitus (T2DM). Methodology: A questionnaire development study was conducted involving CHI linguistic translation, its modification through literature review and focus group discussions, panel synthesis, and content validity. A cross-sectional analytic study followed by administration of the questionnaire to 117 adult Filipinos with T2DM, advanced age, long-standing T2DM, insulin or sulfonylurea, polypharmacy, comorbidities and/or prior hypoglycemia. There were 9 participants in pilot testing, 69 in criterion validity against continuous glucose monitoring (CGM), and 108 in construct validity. Results: IHA domains in the concept map included Elusive Euglycemia Model, Developmental Model, and Cognitive Model. The Filipino-CHI formulated had 8 questions with content validity scores ranging from 87.5-93.75%. Owing to brevity, its internal consistency Cronbach’s alpha was 0.45. Criterion validity against CGM yielded 21 patients with biochemical hypoglycemic events, of which 2 had clinical hypoglycemic events and 19 were positive monitor-identified IHA. A questionnaire IHA cutoff score of ≥4 had sensitivity of 89.47%, and area under the curve of 0.55. Conclusion An 8-item questionnaire evaluating IHA among adult Filipino T2DM patients was developed and validated.
Diabetes Mellitus ; Hypoglycemia ; Surveys and Questionnaires

Objective: The objective of this study is to determine the level of adherence of T2DM patients to the recommended self-care behavior: healthy eating, being active, glucose monitoring, medication adherence, problem-solving, healthy coping and risks reduction. Methodology: This is a cross-sectional study consisting of administration of the Behavior Score Instrument among 126 diagnosed T2DM patients in the Outpatient Department of the Philippine General Hospital. Data obtained were encoded and analysed using the Stata 12 program where a corresponding score was given to the answers to every question and the average was stratified by the level of adherence to the recommended self-care behaviors. Results and Conclusion Majority of the participants have good adherence in five of the seven identified self-care behaviors: medication taking (76.2%), healthy coping (65.9%), healthy eating (50.0%), problem solving (47.6%) and being active (46.0%). In terms of glucose monitoring and risks reduction, 63.5% and 55.6% of the participants have fair adherence respectively. Overall, 43.7% have good compliance to the self-care behaviors while 54.8% and 1.6% have fair and poor compliance respectively.
Self Care ; Behavior

BACKGROUND:The national prevalence of goiters in the Philippines was 3.7% in 1987 and 6.7% in 1993. Since then, there has been no follow-up survey on goiter prevalence, nor has there been any national survey on the prevalence of abnormal thyroid dysfunction. The PhilTiDeS is a survey on the prevalence of both goiters and thyroid disorders in the Philippines.
OBJECTIVES:To determine the prevalence of various categories of abnormal thyroid dysfunction among the Filipino non-pregnant adult population and to describe the prevalence of thyroid enlargement in the Philippines in relation to thyroid dysfunction status.
MATERIALS AND METHODS:The PhilTiDes was a substudy of the 2008 National Nutrition and Health Survey (NNHeS), which covered all 17 regions and 80 provinces of the Philippines. It included all Filipino adults 20 years and older, who are non-pregnant and non-lactating. A standard questionnaire was used to collect data on previous diagnosis and current treatment for thyroid disorders, and neck examination by trained field personnel was done to assess the presence of goiter. Blood was extracted, processed and sent to an accredited laboratory for free T4 and TSH testing using micro-particle enzyme immunoassay.
RESULTS: A total of 4897 persons had thyroid function tests. Of these, 417 (8.53%) had thyroid function abnormalities with the most common abnormality being subclinical hyperthyroidism occurring in 5.33%. The other categories had the following prevalence: true hyperthyroidism 0.61% ; true hypothyroidism 0.41%; and subclinical hypothyroidism 2.18%. Majority of the population 4480 (91.47%) had normal thyroid function tests. Of those with subclinical hyperthyroidism, 55% are females with mean age of 48 years (95% CI 45.9-50.1 years) compared with the volunteers with normal thyroid function who were younger (mean age of 43.1, 95% CI 42.5-43.6 years). Out of the 7,227 volunteers who responded to the survey and clinical examination, a total of 674 (8.9%) had goiters. Out of the 674 subjects with goiters, 379 had diffuse enlargement (56%) while the rest had nodular goiter (44%). Among the sub-population (n= 4897) who underwent thyroid function testing, 9% of those with normal thyroid function tests have goiters.
CONCLUSION: The prevalence of thyroid function abnormalities in the Philippines is 8.53% with the greatest proportion of volunteers having subclinical thyroid disease. There is a low prevalence of both true or overt hyperthyroidism and hypothyroidism. In the larger survey, it was found that 8.9% of volunteers who were examined had goiters. The etiology of these goiters will need to be ascertained in future studies.

Human ; Male ; Female ; Middle Aged ; Adult ; Goiter, Nodular ; Health Surveys ; Hyperthyroidism ; Hypothyroidism ; Immunoenzyme Techniques ; Philippines ; Prevalence ; Thyroid Diseases ; Thyroid Function Tests ; Volunteers