Medwell Study
Tahapan Penelitian : Recruit
Sponsor:
PT. Bio Farma (Persero)
Mitra Pelaksana:
RS. Immanuel - Bandung, PT. Prodia Diacro Laboratories
No Registry
INA-Q3MRSSX
Tanggal Input Registry : 27-09-2022
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 31-10-2022 |
| Outcome Primer | Progression of HbA1c after the treatment of Medwell digital application in addition to regular diabetic treatment and compared it with only regular diabetic treatment of diabetic subjects. |
| Outcome Skunder | a. Compliance of physical activities and exercise prescribed by physicians to subjects. b. Compliance of administered drugs prescribed to subjects. c. Progression of BMI and body composition of subjects. d. Progression of blood pressure of subjects. e. Progression of other laboratory measurements related to diabetes mellitus type 2 (blood glucose profile) f. Progression of blood lipid profile of subjects. |
| Descriptive Information | |
| Judul Penelitian Popular | Medwell Study |
| Judul Penelitian Ilmiah | A Randomized Trial of Preventive Care System Application Effectiveness on the Treatment of Diabetic Patients in Bandung |
| Jenis Penelitian | Interventional |
| Intervensi | Treatment group: Subject receiving regular diabetes treatment with additional Medwell digital application. Control group: Subjects receiving regular diabetes treatment without additional Medwell digital application. |
| Jumlah Subyek Penelitian | 160 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 1. Subjects are in the diabetes type 2 status (based on Perkeni standard) 2. HbA1c is 6.5-9% 3. Aged 18 – 60 years old 4. Have compatible smartphone (minimum android 10 or iOS 14) and internet connection 5. Receiving regular diabetes treatment 6. Giving consent and commitment to participate in the study until finish 7. Located in Bandung Area within the treatment period (up to 3 months after receiving the treatment) 8. Subject is determined to be able to complete daily physical activities.Exclusion Criteria: 1. Pregnant (based on test pack) 2. Participation in other weight loss program 3. Use of other tracking application 4. Having any abnormalities that affecting blood erythrocyte age defined by laboratory examination 5. 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 |
| Administrative Information | |
| Nomor Persetujuan Etik | 71/A01/EC/IX/2022 dated 15 September 2022 |
| Nomor Persetujuan Material Transfer Agreement | |
| Nomor Persetujuan Pelaksanaan Uji Klinik | |
| Other Study ID Numbers | Tidak Ada |
| Contact Person | Kiki Hendarsyah; Dr. Ratih Nursiana, Sp.PD. |