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| Name | Class |
|---|---|
| Immanuel Hospital, Berlin, Germany | OTHER |
| Prodia the CRO | UNKNOWN |
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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Treatment) | Experimental | Regular diabetes treatment with additional Medwell application and wearable device. |
|
| Group II (Control) | Active Comparator | Regular diabetes treatment only with a diary card to record daily activities manually. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medwell Preventive Care Application | Device | Regular diabetes treatment with additional Medwell application and wearable device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1C 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 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the exercise | Mean weekly frequency of exercise | 3 months |
| Evaluate the exercise | Proportion of exercise prescribed by physicians timely performed by subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asep Irham, MD | Contact | +62222033755 | asep.irham@biofarma.co.id | |
| Salwa Halimatussadiy | Contact | +62222033755 | salwa.halimatussadiy@biofarma.co.id |
| Name | Affiliation | Role |
|---|---|---|
| Ratih Nursiana | RS Immanuel | Principal Investigator |
| Indahwaty Indahwaty | RS Immanuel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Immanuel Hospital | Recruiting | Bandung | West Java | 40234 | Indonesia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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| Manual Records | Device | Regular diabetes treatment only with a diary card to record daily activities manually. |
|
| 3 months |
| Evaluate the exercise | Mean duration of each exercise | 3 months |
| Drug Adherence | Proportion of administered drugs timely consumed by subjects | 3 months |
| Anthropometry I (BMI) | Change in the BMI after 3 months | 3 months |
| Anthropometry II (Body Fat) | Change in the Body Fat after 3 months | 3 months |
| Anthropometry III (Muscle Mass) | Change in the Muscle Mass after 3 months | 3 months |
| Lab outcome I (Fasting glucose) | Change in the lab measurement from baseline to month 3 for fasting glucose | 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 | 3 months |
| Lab outcome III (total cholesterol) | Change in the lab measurement from baseline to month 3 for total cholesterol | 3 months |
| Lab outcome IV (low density lipoprotein) | Change in the lab measurement from baseline to month 3 for low density lipoprotein | 3 months |
| Lab outcome V (high density lipoprotein) | Change in the lab measurement from baseline to month 3 for high density lipoprotein | 3 months |
| Lab outcome VI (triglyceride) | Change in the lab measurement from baseline to month 3 for triglyceride | 3 months |
| D004700 | Endocrine System Diseases |