Type 2 DiabetesNCT04161170
Digital Integrated Healthcare Platform in Patients With Type 2 Diabetes
A study testing Digital integrated healthcare platform in people with Type 2 Diabetes, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In this three multicenter clinical trial, investigators will study the efficacy of digital integrated healthcare platform and CGMS (continuous glucose monitoring system) on diabetes management in patients with Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Digital integrated healthcare platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Nov 2019to 31 Dec 2021
- 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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19~70 aged patients with type 2 diabetes
- Patients who have not taken diabetic medications for more than 4 weeks and patients who have taken at least one type of oral hypoglycemic agents at same dosage for more than 12 weeks
- Those who have glycated hemoglobin within 7.0% to 8.5% within the last 3 months
- overweight or obese: BMI (body mass index) ≥ 23 kg / m2
- Those who have agreed to use medical record and participate research by applying the digital integrated healthcare platform
- Those who voluntarily signed the consent form after listening the explanation of the clinical trial.
Who cannot join
- Diabetes other than type 2 diabetes, including type 1 diabetes and gestational diabetes
- Those who are receiving insulin or GLP-1 agonist other than oral hypoglycemic agents
- Uncontrolled chronic liver disease (hemochromatosis, liver cancer, autoimmune liver disease, cirrhosis of the liver, viral hepatitis-includes all A, B and C, Wilson's disease)
- Those with acute renal failure (up to 1.5 times higher than existing serum creatinine)
- Those with mental illness (schizophrenia, depression, bipolar disorder, etc.)
- Those who are currently taking weight loss agents
Show all 10Show fewer
- Those who had alcohol or drug addiction within the last three months
- Those who are taking medications that may affect glucose metabolism (eg, corticosteroids, immunoreactive drugs, etc.)
- Those who are pregnant or lactating and planning to become pregnant during the clinical trial (women of childbearing age may agree to the contraceptive plan).
- Those who are deemed inappropriate for participation in clinical trials
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Jae Hyeon Kim, M.D.,Ph. D, 82-2-3410-1580, jaehyeonmd.kim@samsung.com
About this study
Official title: Validation of Diabetes Management Effectiveness of Digital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring System
In this three multicenter clinical trial, investigators will study the efficacy of digital integrated healthcare platform and CGMS (continuous glucose monitoring system) on diabetes management in patients with Type 2 diabetes. The platform is based on monitoring and intervention by medical staff using AI (aritificial intelligence)-based diet management solution.
The study group includes 3 groups; a total of 294 participants with 1:1:1 randomized allocation: Control group A (no intervention and conventional diabetes management with regular outpatiant clinic visit every 3 months), Interventional group B (applying digital integrated healthcare platform by themselves, no monitoring and intervention by medical staff), and Interventional group C (applying digital integrated healthcare platform based on monitoring and intervention by medical staff using AI-based diet management solution and applying CGMS).
This parallel study will be conducted for 48 weeks.
Read the detailed description
The reason why it is difficult to improve the lifestyle of patients with diabetes using existing digital healthcare applications (apps) is that there is a limit of sustainability that most people do not continue to use digital healthcare apps, thus, it can be possible only with monitoring and intervention by medical staff.
Not only users, but also medical staff can access integrated biometric data on the digital integrated healthcare platform so that individual patient-specific management systems that monitor and intervene can continuously motivate patients to manage themselves. Also, it could be a prerequisite for the successful management of patients with diabetes using digital healthcare apps, many existing apps have been identified as failure cases in previous studies. In this clinical trial, investigators will study the efficacy of digital integrated healthcare platform based on monitoring and intervention by medical staff using AI (aritifical intelligence)-based diet management solution.
In addition, in this clinical trial, the latest medical device, real-time continuous glucose monitoring system (CGMS) will be applied to monitor blood glucose levels. It has been reported that glucose level is well controlled when the number of self blood glucose measurement is performed frequently, but in practice, patients have time and space limitation in self blood glucose measurement, and it is difficult to change the management pattern of patients by encouraging self blood glucose measurement. Therefore, by applying a CGMS every three months, not only the patient but also the medical staff can access the 24-hour blood glucose values, and can actively participate in the blood sugar management of the patients. Therefore, investigators plan to conduct clinical trial using digital integrated healthcare platform using AI-based diet management solution and real-time CGMS
- Conditions
- Type 2 Diabetes
- Being tested
- Digital integrated healthcare platform
- Keywords
- Continuous glucose monitoring system, Artificial intelligence, Diabetes, Digital healthcare, Education
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital integrated healthcare platformDevice
Digital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring system
| Study group | Role | What they receive |
|---|---|---|
| Control A | No intervention | no intervention conventional diabetes treatment and clinic visit every 3 months |
| Intervention B | Active comparator | apply digital integrated healthcare platform clinic visit every 3 months Receives: Device: Digital integrated healthcare platform |
| Intervention C | Experimental | apply digital integrated healthcare platform, CGMS, and medical team monitoring, and education clinic visit every 3 months Receives: Device: Digital integrated healthcare platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbA1c (glycated hemoglobin) at 6months from baseline
Change of HbA1c (glycated hemoglobin) at 6months from baseline
Measured: Change of HbA1c (glycated hemoglobin) at 6months from baseline
Secondary outcomes (26)
HbA1c
glycated hemoglobin
Measured: glycated hemoglobin at baseline, 3, 6, 12 months
number of intervention for education in interventinal group C
The number of educational intervention by digital integrated healthcare platform
Measured: number of intervention for education in interventinal group C at baseline, 3, 6, 12 months
hypoglycemic events
the number of hypoglycemic events
Measured: hypoglycemic events at baseline, 3, 6, 12 months
adverse events
the number and types of hypoglycemic events
Measured: adverse events at baseline, 3, 6, 12 months
patient satisfaction questionnaire score
patient satisfaction questionnaire score includes 8 questions and each question has score range 0 (min) - 6 (max). For questions number 2 and 3, higher score mean worse outcome in hypoglycemia but for the rest of questions, higher scores mean better outcome in diabetes management.
Measured: patient satisfaction questionnaire score at baseline, 3, 6, 12 months
body weight
body weight
Measured: body weight at baseline, 3, 6, 12 months
BMI (body mass index)
BMI (body mass index)
Measured: BMI at baseline, 3, 6, 12 months
body fat (%)
body fat (%)
Measured: body fat (%) at baseline, 3, 6, 12 months
step count
step count
Measured: average step count at baseline, 3, 6, 12 months
burned calories
burned calories
Measured: average burned calories at baseline, 3, 6, 12 months
walking distances
walking distances
Measured: average walking distances at baseline, 3, 6, 12 months
intake calories
intake calories
Measured: intake calories at baseline, 3, 6, 12 months
fasting glucose level
fasting glucose level
Measured: average fasting glucose level at baseline, 3, 6, 12 months
total cholesterol level
total cholesterol level
Measured: total cholesterol level at baseline, 3, 6, 12 months
HDL cholesterol level
HDL cholesterol level
Measured: HDL cholesterol level at baseline, 3, 6, 12 months
Triglycerides level
Triglycerides level
Measured: Triglycerides level at baseline, 3, 6, 12 months
LDL cholesterol level
LDL cholesterol level
Measured: LDL cholesterol level at baseline, 3, 6, 12 months
mean glucose level by CGMS (continuous glucose monitoring system) in interventional group C
mean glucose level by CGMS in interventional group C
Measured: mean glucose level by CGMS at baseline, 3, 6, 12 months
glycemic variability by CGMS in interventional group C
glycemic variability by CGMS in interventional group C
Measured: glycemic variability by CGMS at baseline, 3, 6, 12 months
standard deviation by CGMS in interventional group C
standard deviation by CGMS in interventional group C
Measured: standard deviation by CGMS at baseline, 3, 6, 12 months
average applying time of CGMS in interventional group C
average applying time of CGMS in interventional group C
Measured: average applying time of CGMS at baseline, 3, 6, 12 months
time in range of <54mg/dL by CGMS in interventional group C
time in range of <54mg/dL by CGMS in interventional group C
Measured: time in range of <54mg/dL by CGMS at baseline, 3, 6, 12 months
time in range of <70mg/dL by CGMS in interventional group C
time in range of <70mg/dL by CGMS in interventional group C
Measured: time in range of <70mg/dL by CGMS at baseline, 3, 6, 12 months
time in range of 70-180 mg/dL by CGMS in interventional group C
time in range of 70-180 mg/dL by CGMS in interventional group C
Measured: time in range of 70-180 mg/dL by CGMS at baseline, 3, 6, 12 months
time in range of >180 mg/dL by CGMS in interventional group C
time in range of >180 mg/dL by CGMS in interventional group C
Measured: time in range of >180 mg/dL by CGMS at baseline, 3, 6, 12 months
time in range of >250 mg/dL by CGMS in interventional group C
time in range of >250 mg/dL by CGMS in interventional group C
Measured: time in range of >250 mg/dL by CGMS at baseline, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start20 Nov 2019
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group A: no intervention Interventional group B: digital integrated healthcare platform Interventional group C: digital integrated healthcare platform + CGMS apply + medical team monitoring + educational intervation
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae Hyeon Kim, MD, PhD, Samsung Medical Center
- Investigators
- Jae Hyeon Kim, MD PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161170
- Sponsor's protocol ID
- 2019-05-028-007
- Status last verified
- Jan 2020
- First submitted
- 8 Nov 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee YB, Kim G, Jun JE, Park H, Lee WJ, Hwang YC, Kim JH. An Integrated Digital Health Care Platform for Diabetes Management With AI-Based Dietary Management: 48-Week Results From a Randomized Controlled Trial. Diabetes Care. 2023 May 1;46(5):959-966. doi: 10.2337/dc22-1929.
PubMed 36821833Park SW, Kim G, Hwang YC, Lee WJ, Park H, Kim JH. Validation of the effectiveness of a digital integrated healthcare platform utilizing an AI-based dietary management solution and a real-time continuous glucose monitoring system for diabetes management: a randomized controlled trial. BMC Med Inform Decis Mak. 2020 Jul 10;20(1):156. doi: 10.1186/s12911-020-01179-x.
PubMed 32650771
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Diabetes Management Effectiveness of Digital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT04161170
- Acronym / sponsor ID
- 2019-05-028-007
- Conditions
- Type 2 Diabetes
- Keywords
- Continuous glucose monitoring system, Artificial intelligence, Diabetes, Digital healthcare, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 13 Nov 2019 (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.
In this three multicenter clinical trial, investigators will study the efficacy of digital integrated healthcare platform and CGMS (continuous glucose monitoring system) on diabetes management in patients with Type 2 diabetes. The platform is based on monitoring and intervention by medical staff using AI (aritificial intelligence)-based diet management solution.
The study group includes 3 groups; a total of 294 participants with 1:1:1 randomized allocation: Control group A (no intervention and conventional diabetes management with regular outpatiant clinic visit every 3 months), Interventional group B (applying digital integrated healthcare platform by themselves, no monitoring and intervention by medical staff), and Interventional group C (applying digital integrated healthcare platform based on monitoring and intervention by medical staff using AI-based diet management solution and applying CGMS).
This parallel study will be conducted for 48 weeks.
Detailed description
The reason why it is difficult to improve the lifestyle of patients with diabetes using existing digital healthcare applications (apps) is that there is a limit of sustainability that most people do not continue to use digital healthcare apps, thus, it can be possible only with monitoring and intervention by medical staff.
Not only users, but also medical staff can access integrated biometric data on the digital integrated healthcare platform so that individual patient-specific management systems that monitor and intervene can continuously motivate patients to manage themselves. Also, it could be a prerequisite for the successful management of patients with diabetes using digital healthcare apps, many existing apps have been identified as failure cases in previous studies. In this clinical trial, investigators will study the efficacy of digital integrated healthcare platform based on monitoring and intervention by medical staff using AI (aritifical intelligence)-based diet management solution.
In addition, in this clinical trial, the latest medical device, real-time continuous glucose monitoring system (CGMS) will be applied to monitor blood glucose levels. It has been reported that glucose level is well controlled when the number of self blood glucose measurement is performed frequently, but in practice, patients have time and space limitation in self blood glucose measurement, and it is difficult to change the management pattern of patients by encouraging self blood glucose measurement. Therefore, by applying a CGMS every three months, not only the patient but also the medical staff can access the 24-hour blood glucose values, and can actively participate in the blood sugar management of the patients. Therefore, investigators plan to conduct clinical trial using digital integrated healthcare platform using AI-based diet management solution and real-time CGMS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Control group A: no intervention Interventional group B: digital integrated healthcare platform Interventional group C: digital integrated healthcare platform + CGMS apply + medical team monitoring + educational intervation
| Arm | Type | Receives |
|---|---|---|
| Control A | No intervention | –no intervention conventional diabetes treatment and clinic visit every 3 months |
| Intervention B | Active comparator | Device: Digital integrated healthcare platformapply digital integrated healthcare platform clinic visit every 3 months |
| Intervention C | Experimental | Device: Digital integrated healthcare platformapply digital integrated healthcare platform, CGMS, and medical team monitoring, and education clinic visit every 3 months |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 19~70 aged patients with type 2 diabetes
- Patients who have not taken diabetic medications for more than 4 weeks and patients who have taken at least one type of oral hypoglycemic agents at same dosage for more than 12 weeks
- Those who have glycated hemoglobin within 7.0% to 8.5% within the last 3 months
- overweight or obese: BMI (body mass index) ≥ 23 kg / m2
- Those who have agreed to use medical record and participate research by applying the digital integrated healthcare platform
Key exclusion criteria (10 listed)
- Diabetes other than type 2 diabetes, including type 1 diabetes and gestational diabetes
- Those who are receiving insulin or GLP-1 agonist other than oral hypoglycemic agents
- Uncontrolled chronic liver disease (hemochromatosis, liver cancer, autoimmune liver disease, cirrhosis of the liver, viral hepatitis-includes all A, B and C, Wilson's disease)
- Those with acute renal failure (up to 1.5 times higher than existing serum creatinine)
- Those with mental illness (schizophrenia, depression, bipolar disorder, etc.)
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 |
|---|---|---|
| Digital integrated healthcare platformDigital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring system | Device | Intervention B, Intervention C |
Primary outcome
Change of HbA1c (glycated hemoglobin) at 6months from baseline
Time frame: Change of HbA1c (glycated hemoglobin) at 6months from baseline
Change of HbA1c (glycated hemoglobin) at 6months from baseline
26 secondary outcomes
HbA1c
Time frame: glycated hemoglobin at baseline, 3, 6, 12 months
number of intervention for education in interventinal group C
Time frame: number of intervention for education in interventinal group C at baseline, 3, 6, 12 months
hypoglycemic events
Time frame: hypoglycemic events at baseline, 3, 6, 12 months
adverse events
Time frame: adverse events at baseline, 3, 6, 12 months
patient satisfaction questionnaire score
Time frame: patient satisfaction questionnaire score at baseline, 3, 6, 12 months
body weight
Time frame: body weight at baseline, 3, 6, 12 months
BMI (body mass index)
Time frame: BMI at baseline, 3, 6, 12 months
body fat (%)
Time frame: body fat (%) at baseline, 3, 6, 12 months
step count
Time frame: average step count at baseline, 3, 6, 12 months
burned calories
Time frame: average burned calories at baseline, 3, 6, 12 months
walking distances
Time frame: average walking distances at baseline, 3, 6, 12 months
intake calories
Time frame: intake calories at baseline, 3, 6, 12 months
fasting glucose level
Time frame: average fasting glucose level at baseline, 3, 6, 12 months
total cholesterol level
Time frame: total cholesterol level at baseline, 3, 6, 12 months
HDL cholesterol level
Time frame: HDL cholesterol level at baseline, 3, 6, 12 months
Triglycerides level
Time frame: Triglycerides level at baseline, 3, 6, 12 months
LDL cholesterol level
Time frame: LDL cholesterol level at baseline, 3, 6, 12 months
mean glucose level by CGMS (continuous glucose monitoring system) in interventional group C
Time frame: mean glucose level by CGMS at baseline, 3, 6, 12 months
glycemic variability by CGMS in interventional group C
Time frame: glycemic variability by CGMS at baseline, 3, 6, 12 months
standard deviation by CGMS in interventional group C
Time frame: standard deviation by CGMS at baseline, 3, 6, 12 months
average applying time of CGMS in interventional group C
Time frame: average applying time of CGMS at baseline, 3, 6, 12 months
time in range of <54mg/dL by CGMS in interventional group C
Time frame: time in range of <54mg/dL by CGMS at baseline, 3, 6, 12 months
time in range of <70mg/dL by CGMS in interventional group C
Time frame: time in range of <70mg/dL by CGMS at baseline, 3, 6, 12 months
time in range of 70-180 mg/dL by CGMS in interventional group C
Time frame: time in range of 70-180 mg/dL by CGMS at baseline, 3, 6, 12 months
time in range of >180 mg/dL by CGMS in interventional group C
Time frame: time in range of >180 mg/dL by CGMS at baseline, 3, 6, 12 months
time in range of >250 mg/dL by CGMS in interventional group C
Time frame: time in range of >250 mg/dL by CGMS at baseline, 3, 6, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 36821833Lee YB, Kim G, Jun JE, Park H, Lee WJ, Hwang YC, Kim JH. An Integrated Digital Health Care Platform for Diabetes Management With AI-Based Dietary Management: 48-Week Results From a Randomized Controlled Trial. Diabetes Care. 2023 May 1;46(5):959-966. doi: 10.2337/dc22-1929.
- Derived from this study: PubMed 32650771Park SW, Kim G, Hwang YC, Lee WJ, Park H, Kim JH. Validation of the effectiveness of a digital integrated healthcare platform utilizing an AI-based dietary management solution and a real-time continuous glucose monitoring system for diabetes management: a randomized controlled trial. BMC Med Inform Decis Mak. 2020 Jul 10;20(1):156. doi: 10.1186/s12911-020-01179-x.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Jae Hyeon Kim, MD PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital integrated healthcare platform in people with Type 2 Diabetes, run by Samsung Medical Center at 1 site in South Korea.
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 6 inclusion and 10 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 18 Jan 2020. 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 South Korea. 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 Jae Hyeon Kim, MD PhD (+82-2-3410-1580, jaehyeonmd.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HbA1c (glycated hemoglobin) at 6months from baseline (time frame: Change of HbA1c (glycated hemoglobin) at 6months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161170, which also lists 2 linked publications.
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 18 Jan 2020.