Diabetes Mellitus, Type 2NCT05657769
Preventive Care System Application Effectiveness Study on the Treatment of Diabetic Patients in Bandung
A study testing Medwell Preventive Care Application and Manual Records in people with Diabetes Mellitus, Type 2, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
Randomized, unblinded, controlled, two arms parallel group, prospective intervention study Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Medwell Preventive Care Application and Manual Records
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteIndonesia
- Study dates
- 12 Nov 2022to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Immanuel Hospital
Bandung, West Java, 40234
Indahwaty Indahwaty
About this study
Official title: A Randomized Trial of Preventive Care System Application Effectiveness on the Treatment of Diabetic Patients in Bandung
Randomized, unblinded, controlled, two arms parallel group, prospective intervention study
Read the 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%.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Medwell Preventive Care Application, Manual Records
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medwell Preventive Care ApplicationDevice
Regular diabetes treatment with additional Medwell application and wearable device.
Manual RecordsDevice
Regular diabetes treatment only with a diary card to record daily activities manually.
| Study group | Role | What they receive |
|---|---|---|
| Group I (Treatment) | Experimental | Regular diabetes treatment with additional Medwell application and wearable device. Receives: Device: Medwell Preventive Care Application |
| Group II (Control) | Active comparator | Regular diabetes treatment only with a diary card to record daily activities manually. Receives: Device: Manual Records |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (13)
Evaluate the exercise
Mean weekly frequency of exercise
Measured: 3 months
Evaluate the exercise
Proportion of exercise prescribed by physicians timely performed by subjects
Measured: 3 months
Evaluate the exercise
Mean duration of each exercise
Measured: 3 months
Drug Adherence
Proportion of administered drugs timely consumed by subjects
Measured: 3 months
Anthropometry I (BMI)
Change in the BMI after 3 months
Measured: 3 months
Anthropometry II (Body Fat)
Change in the Body Fat after 3 months
Measured: 3 months
Anthropometry III (Muscle Mass)
Change in the Muscle Mass after 3 months
Measured: 3 months
Lab outcome I (Fasting glucose)
Change in the lab measurement from baseline to month 3 for fasting glucose
Measured: 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
Measured: 3 months
Lab outcome III (total cholesterol)
Change in the lab measurement from baseline to month 3 for total cholesterol
Measured: 3 months
Lab outcome IV (low density lipoprotein)
Change in the lab measurement from baseline to month 3 for low density lipoprotein
Measured: 3 months
Lab outcome V (high density lipoprotein)
Change in the lab measurement from baseline to month 3 for high density lipoprotein
Measured: 3 months
Lab outcome VI (triglyceride)
Change in the lab measurement from baseline to month 3 for triglyceride
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start12 Nov 2022
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immanuel Hospital, Berlin, Germany, Prodia the CRO
- Responsible party
- Sponsor
- Investigators
- Ratih Nursiana, Principal investigator, RS ImmanuelIndahwaty Indahwaty, Study director, RS Immanuel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657769
- Sponsor's protocol ID
- Medwell-01-2022
- Status last verified
- Apr 2023
- First submitted
- 12 Dec 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Preventive Care System Application Effectiveness on the Treatment of Diabetic Patients in Bandung
- ClinicalTrials.gov ID
- NCT05657769
- Acronym / sponsor ID
- Medwell-01-2022
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Immanuel Hospital, Berlin, Germany, Prodia the CRO
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group I (Treatment) | Experimental | Device: Medwell Preventive Care ApplicationRegular diabetes treatment with additional Medwell application and wearable device. |
| Group II (Control) | Active comparator | Device: Manual RecordsRegular diabetes treatment only with a diary card to record daily activities manually. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medwell Preventive Care ApplicationRegular diabetes treatment with additional Medwell application and wearable device. | Device | Group I (Treatment) |
| Manual RecordsRegular diabetes treatment only with a diary card to record daily activities manually. | Device | Group II (Control) |
Primary outcome
HbA1C Changes
Time frame: 3 months
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
13 secondary outcomes
Evaluate the exercise
Time frame: 3 months
Evaluate the exercise
Time frame: 3 months
Evaluate the exercise
Time frame: 3 months
Drug Adherence
Time frame: 3 months
Anthropometry I (BMI)
Time frame: 3 months
Anthropometry II (Body Fat)
Time frame: 3 months
Anthropometry III (Muscle Mass)
Time frame: 3 months
Lab outcome I (Fasting glucose)
Time frame: 3 months
Lab outcome II (2 hours post prandial glucose)
Time frame: 3 months
Lab outcome III (total cholesterol)
Time frame: 3 months
Lab outcome IV (low density lipoprotein)
Time frame: 3 months
Lab outcome V (high density lipoprotein)
Time frame: 3 months
Lab outcome VI (triglyceride)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ratih Nursiana principal investigator
RS Immanuel
Indahwaty Indahwaty study director
RS Immanuel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medwell Preventive Care Application and Manual Records in people with Diabetes Mellitus, Type 2, run by PT Bio Farma at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asep Irham, MD (+62222033755, asep.irham@biofarma.co.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C Changes (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.