Randomized, unblinded, controlled, two arms parallel group, prospective intervention study
The objective of the study is to compare the progression of HbA1c in diabetic patients after applying a Medwell digital application in addition to regular diabetes treatment (treatment arm) with regular diabetes treatment of diabetic subjects alone (control arm). The primary endpoint will be measured as the difference between 3 months HbA1c relative to baseline in eligible subjects. Normally, HbA1c in each subject is expected to either stable or slightly increase overtime. In this study we are interested in measuring the difference in HbA1c 3 months post randomization. It is expected that in the experimental arm, HbA1c will slightly decrease, while in the standard arm, HbA1c will either remain the same or will slightly increase after 3 months in the study. Previous study shows that the standard deviation of the difference in HbA1c within 1 year is 0.97%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
160
Regular diabetes treatment with additional Medwell application and wearable device.
Regular diabetes treatment only with a diary card to record daily activities manually.
Immanuel Hospital
Bandung, West Java, Indonesia
RECRUITINGHbA1C Changes
Change in HbA1c from baseline to month 3 for all groups. Change in HbA1c from baseline to month 3 for all groups. Change in HbA1C from baseline to moth 3 of all group
Time frame: 3 months
Evaluate the exercise
Mean weekly frequency of exercise
Time frame: 3 months
Evaluate the exercise
Proportion of exercise prescribed by physicians timely performed by subjects
Time frame: 3 months
Evaluate the exercise
Mean duration of each exercise
Time frame: 3 months
Drug Adherence
Proportion of administered drugs timely consumed by subjects
Time frame: 3 months
Anthropometry I (BMI)
Change in the BMI after 3 months
Time frame: 3 months
Anthropometry II (Body Fat)
Change in the Body Fat after 3 months
Time frame: 3 months
Anthropometry III (Muscle Mass)
Change in the Muscle Mass after 3 months
Time frame: 3 months
Lab outcome I (Fasting glucose)
Change in the lab measurement from baseline to month 3 for fasting glucose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3 months
Lab outcome II (2 hours post prandial glucose)
Change in the lab measurement from baseline to month 3 for 2 hours postprandial glucose
Time frame: 3 months
Lab outcome III (total cholesterol)
Change in the lab measurement from baseline to month 3 for total cholesterol
Time frame: 3 months
Lab outcome IV (low density lipoprotein)
Change in the lab measurement from baseline to month 3 for low density lipoprotein
Time frame: 3 months
Lab outcome V (high density lipoprotein)
Change in the lab measurement from baseline to month 3 for high density lipoprotein
Time frame: 3 months
Lab outcome VI (triglyceride)
Change in the lab measurement from baseline to month 3 for triglyceride
Time frame: 3 months