Clinical trial NCT05657769: Preventive Care System Application Effectiveness Study on the Treatment of Diabetic Patients in Bandung
Official title: A Randomized Trial of Preventive Care System Application Effectiveness on the Treatment of Diabetic Patients in Bandung
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: PT Bio Farma
Sponsor class: INDUSTRY
Collaborators: name: Immanuel Hospital
name: Prodia the CRO
First posted: 2022-12-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is conducted with the primary hypothesis that the diabetes treatment with Medwell intervention can significantly reduce the HbA1c level better than without Medwell intervention.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomized, unblinded, controlled, two arms parallel group, prospective intervention study

Detailed description: 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%.

Eligibility criteria: Inclusion Criteria:

* Subjects are in the diabetes type 2 status (based on Perkeni standard) HbA1c is ≥6.5%
* Aged 18 - 60 years old
* Have compatible smartphone (minimum android 8 or iOS 13) and internet connection
* Receiving regular diabetes treatment
* Giving consent and commitment to participate in the study until finish
* Located in Bandung Area within the treatment period (up to 3 month after receiving the treatment)
* Subject is determined to be able to complete daily physical activities.

Exclusion Criteria:

* Pregnant (based on test pack)
* Participation in other weight loss program
* Use of other tracking application
* Having any abnormalities that affecting blood erythrocyte age defined by laboratory examination
* Have other severe diabetic complications that prevent subjects from participating in the prescribed program (Such as stroke, cardiac diseases (CHF stage III-IV), COPD or asthma with acute exacerbation and other respiratory diseases, peripheral artery disease, CKD stage 3-5) and other severe diseases that by the investigator's judgment, could not participate in this study

Primary outcomes:
measure: HbA1C Changes
timeFrame: 3 months
Secondary outcomes:
measure: Evaluate the exercise
timeFrame: 3 months
measure: Evaluate the exercise
timeFrame: 3 months
measure: Evaluate the exercise
timeFrame: 3 months
measure: Drug Adherence
timeFrame: 3 months
measure: Anthropometry I (BMI)
timeFrame: 3 months
measure: Anthropometry II (Body Fat)
timeFrame: 3 months
measure: Anthropometry III (Muscle Mass)
timeFrame: 3 months
measure: Lab outcome I (Fasting glucose)
timeFrame: 3 months
measure: Lab outcome II (2 hours post prandial glucose)
timeFrame: 3 months
measure: Lab outcome III (total cholesterol)
timeFrame: 3 months
measure: Lab outcome IV (low density lipoprotein)
timeFrame: 3 months
measure: Lab outcome V (high density lipoprotein)
timeFrame: 3 months
measure: Lab outcome VI (triglyceride)
timeFrame: 3 months
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Immanuel Hospital
state: West Java
Study officials:
affiliation: RS Immanuel
name: Ratih Nursiana
role: PRINCIPAL_INVESTIGATOR
affiliation: RS Immanuel
name: Indahwaty Indahwaty
role: STUDY_DIRECTOR
References: