Diabetes Mellitus Type 2 - Insulin-TreatedNCT04678661
My Dose Coach Mobile App to Support Insulin Titration and Maintenance
A study testing Smartphone application and web portal and Standard Insulin Therapy Education in people with Diabetes Mellitus Type 2 - Insulin-Treated, run by Linda Siminerio at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate an electronic application (app) designed to help people with type 2 diabetes (T2DM) adjust their insulin doses. The app is called My Dose Coach. This research study is being done in 2 phases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2 - Insulin-Treated
- What is being tested?
- Smartphone application and web portal and Standard Insulin Therapy Education
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 16 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intervention Group
- Patient receiving care at a UPMC Diabetes Outpatient and/or Inpatient settings
- Adult male and female patients 18 to 75 years old
- HbA1c > 7.5%
- Recommended to start self titration of basal insulin
- Access to and able to use an iOS (Apple phone operating system) or Android enabled device and have reliable internet access
Show all 13Show fewer
- Willing and able to use the MDC app
- Able to comprehend basic diabetes survival skills, signs and symptoms of hypoglycemia and treatment of BG
- Usual Care Group
- Adult male and female patients 18 to 75 years old
- HbA1c > 7.5%
- Started on basal insulin in a UPMC Diabetes Outpatient facility within the past three years of study start
- Has blood glucose data available in electronic medical records (EMR) (At least two HbA1c measurements corresponding to baseline and a subsequent time point after insulin titration)
Who cannot join
- Pregnant or breastfeeding
- Patients unwilling to use MDC app
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: My Dose Coach Titration and Maintenance in Patients With Type 2 Diabetes Mellitus on Basal Insulin
The purpose of this research study is to evaluate an electronic application (app) designed to help people with type 2 diabetes (T2DM) adjust their insulin doses. The app is called My Dose Coach. This research study is being done in 2 phases. Specifically in Phase 1, the study is assessing the role of the My Dose Coach app in helping participants make insulin adjustments to get their blood glucoses to the target level that is planned for with the diabetes team, called the dosing or titration phase, when first starting insulin. In Phase 2, the study is assessing the role of the My Dose Coach app in helping participants keep blood glucoses in the target range, called the maintenance phase.
Read the detailed description
Despite the increasing body of knowledge of diabetes treatment strategies, a majority of patients with T2DM are still in a persistent state of poor glycemic control and unable to meet target goals. Inertia surrounding insulin initiation and titration is a specific problem. Various approaches have been proposed to help overcome clinical inertia, including support of patient self-management, and education for both physicians and people with diabetes. Presently, paper-based guides are available in which clinicians/educators rely on to help their patients in determining and recording appropriate insulin doses. Unfortunately, this process often sets the stage for reluctance and fear of insulin initiation and delays titration with implications for long-term poor self-management and adherence. Therefore, Sanofi developed the My Dose Coach electronic app to assist with optimizing titration of basal insulins and supporting proper insulin maintenance. The primary objective of this two phase study is to demonstrate that patients who are trained on the My Dose Coach app to titrate insulin will have greater improvements in hemoglobin A1c and will be more likely to achieve glycemic control at three months as compared to usual care practice, and, for the intervention group only, those who do attain glycemic goals will be able to maintain glycemic control for an additional three months. The secondary objective of this study is to examine the feasibility of integrating digital solutions into clinical workflow and user acceptability of My Dose Coach.
- Being tested
- Smartphone application and web portal, Standard Insulin Therapy Education
- Keywords
- Mobile application, Digital titration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone application and web portalDevice
Also called My Dose Coach
My Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. MDC is intended as an aid to the patient to provide dose suggestions based upon the HCP's independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient Instructions. The application uses the dose plan instructions provided by the patient's HCP to provide dose suggestions of once-daily long-acting basal insulin (i.e. basal insulin titration) that are based on the patient's Fasting Blood Glucose (FBG) as well as hypoglycemia occurrence.
MDC includes a Maintenance Module designed to support patients in maintaining proper insulin dosingby enabling logging of administered doses of prescribed diabetes medications and BGM and providing dosing and measurement reminders.
Standard Insulin Therapy EducationBehavioural
Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.
| Study group | Role | What they receive |
|---|---|---|
| My Dose Coach (Insulin Dosing Support App) | Experimental | Phase 1 Titration: Patients receive insulin therapy education from diabetes educator (DE). Plus, DE trains patients to use My Dose Coach (MDC) for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients are asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reach glycemic target are invited to Phase 2. Other patients are invited to continue titrating for another 3 months.
Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trains patients the MDC Maintenance Module to support proper insulin dosing. Patients are asked to return for follow-up clinic visits at mo 6.
Patients are surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability. Receives: Device: Smartphone application and web portal; Behavioral: Standard Insulin Therapy Education |
| Usual Care Group | Active comparator | A retrospective comparative group will be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group will be identified using data available in the electronic medical record system. Propensity score matching will be used to pair intervention and usual care participants during phase 1 of the study (baseline to 3 months). Receives: Behavioral: Standard Insulin Therapy Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycemic Control at 3 Months
Average change in hemoglobin A1c from baseline to 3 months
Measured: Baseline to 3 months
Secondary outcomes (14)
Change From Baseline in Fasting Blood Glucose at 3 Months
Change in fasting blood glucose from baseline to 3 months for the intervention group.
Measured: Baseline to 3 months
Change From Baseline in Fasting Blood Glucose at 6 Months
Change in fasting blood glucose from baseline to 6 months for the intervention group.
Measured: Baseline to 6 months
Change From 3 Months in Fasting Blood Glucose at 6 Months
Chang in fasting blood glucose from month 3 to 6 for the intervention group.
Measured: Months 3 to 6
Change From Baseline in Hemoglobin A1c at 6 Months
Average change in hemoglobin A1c from baseline to 6 months for the intervention group.
Measured: Baseline to 6 months
Change From 3 Months in Hemoglobin A1c at 6 Months
Average change in hemoglobin A1c from 3 months to 6 months for the intervention group.
Measured: Months 3 to 6
Proportion of Patients Who Achieve Glycemic Targets
Achieving glycemic target defined as reduction in hemoglobin A1c <7% by 3 months after baseline
Measured: 3 months
Proportion of Patients Who Maintain Glycemic Targets
Maintaining glycemic target defined as maintaining a hemoglobin A1c <7% at 6 months for those who achieved this target at 3 months in the intervention group.
Measured: 6 months
Change From Baseline in Diabetes Distress at 3 Months
Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.
Measured: Baseline to 3 months
Change From Baseline in Diabetes Distress at 6 Months
Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.
Measured: Baseline to 6 months
Change From 3 Months in Diabetes Distress at 6 Months
Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6.
Measured: Month 3 to month 6
Participant Acceptability of Insulin Dosing Support System for Insulin Titration
Participants rated their acceptability of My Dose Coach using a study-specific survey. Individual items are scored from 1 to 5; total scores are the average of all individual item scores; . Possible score range 1 to 5. The higher the score, the better the rating or acceptability of the insulin dosing support system.
Measured: 3 months
Participant Satisfaction With Insulin Treatment
The Diabetes Medication Systems Rating Questionnaire-Short Form, was also be used to inform patient acceptability and satisfaction with insulin. This questionnaire includes 20 items to assess convenience, negative events, interference, self-monitoring of blood glucose burden, efficacy, social burden, psychological well-being, treatment satisfaction and treatment preference. All items are scored 0 to 100. Composite score is calculated as means of completed items. Possible score range is 0 to 100. The higher the score, the higher the level of satisfaction.
Measured: 6 months
Number of Hypoglycemic Events
Total number of hypoglycemic events where blood glucose <70mg/dl.
Measured: As reported across study period, up to 6 months
Number of Participants Who Experienced Severe Hypoglycemic Events.
Severe hypoglycemic events were defined a hypoglycemic events that required assistance of another person to resuscitate because blood glucoses are too low to maintain consciousness.
Measured: As reported across study period, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start15 Feb 2021
- Primary completion30 Dec 2022
- Study completion16 Feb 2023
Why it stopped: Technical issues with app and prolonged recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2 - Insulin-TreatedStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linda Siminerio
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, Linda Siminerio, University of Pittsburgh
- Investigators
- Linda Siminerio, RN, PhD, CDE, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678661
- Sponsor's protocol ID
- STUDY20040308
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2020
- Last updated
- 14 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: A consent form used in enrolling participants will be posted.
Publications
Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
PubMed 15735199Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6.
PubMed 22228744Peyrot M, Xu Y, Rubin RR. Development and validation of the Diabetes Medication System Rating Questionnaire-Short Form. Diabet Med. 2014 Oct;31(10):1237-44. doi: 10.1111/dme.12453. Epub 2014 Apr 18.
PubMed 24673614
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Dose Coach Titration and Maintenance in Patients With Type 2 Diabetes Mellitus on Basal Insulin
- ClinicalTrials.gov ID
- NCT04678661
- Acronym / sponsor ID
- STUDY20040308
- Keywords
- Mobile application, Digital titration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical issues with app and prolonged recruitment
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Linda SiminerioUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Posted 14 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate an electronic application (app) designed to help people with type 2 diabetes (T2DM) adjust their insulin doses. The app is called My Dose Coach. This research study is being done in 2 phases. Specifically in Phase 1, the study is assessing the role of the My Dose Coach app in helping participants make insulin adjustments to get their blood glucoses to the target level that is planned for with the diabetes team, called the dosing or titration phase, when first starting insulin. In Phase 2, the study is assessing the role of the My Dose Coach app in helping participants keep blood glucoses in the target range, called the maintenance phase.
Detailed description
Despite the increasing body of knowledge of diabetes treatment strategies, a majority of patients with T2DM are still in a persistent state of poor glycemic control and unable to meet target goals. Inertia surrounding insulin initiation and titration is a specific problem. Various approaches have been proposed to help overcome clinical inertia, including support of patient self-management, and education for both physicians and people with diabetes. Presently, paper-based guides are available in which clinicians/educators rely on to help their patients in determining and recording appropriate insulin doses. Unfortunately, this process often sets the stage for reluctance and fear of insulin initiation and delays titration with implications for long-term poor self-management and adherence. Therefore, Sanofi developed the My Dose Coach electronic app to assist with optimizing titration of basal insulins and supporting proper insulin maintenance. The primary objective of this two phase study is to demonstrate that patients who are trained on the My Dose Coach app to titrate insulin will have greater improvements in hemoglobin A1c and will be more likely to achieve glycemic control at three months as compared to usual care practice, and, for the intervention group only, those who do attain glycemic goals will be able to maintain glycemic control for an additional three months. The secondary objective of this study is to examine the feasibility of integrating digital solutions into clinical workflow and user acceptability of My Dose Coach.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| My Dose Coach (Insulin Dosing Support App) | Experimental | Device: Smartphone application and web portal, Behavioral: Standard Insulin Therapy EducationPhase 1 Titration: Patients receive insulin therapy education from diabetes educator (DE). Plus, DE trains patients to use My Dose Coach (MDC) for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients are asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reach glycemic target are invited to Phase 2. Other patients are invited to continue titrating for another 3 months. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trains patients the MDC Maintenance Module to support proper insulin dosing. Patients are asked to return for follow-up clinic visits at mo 6. Patients are surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability. |
| Usual Care Group | Active comparator | Behavioral: Standard Insulin Therapy EducationA retrospective comparative group will be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group will be identified using data available in the electronic medical record system. Propensity score matching will be used to pair intervention and usual care participants during phase 1 of the study (baseline to 3 months). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Intervention Group
- Patient receiving care at a UPMC Diabetes Outpatient and/or Inpatient settings
- Adult male and female patients 18 to 75 years old
- HbA1c > 7.5%
- Recommended to start self titration of basal insulin
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding
- Patients unwilling to use MDC app
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 |
|---|---|---|
| Smartphone application and web portalAlso: My Dose CoachMy Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. MDC is intended as an aid to the patient to provide dose suggestions based upon the HCP's independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient Instructions. The application uses the dose plan instructions provided by the patient's HCP to provide dose suggestions of once-daily long-acting basal insulin (i.e. basal insulin titration) that are based on the patient's Fasting Blood Glucose (FBG) as well as hypoglycemia occurrence. MDC includes a Maintenance Module designed to support patients in maintaining proper insulin dosingby enabling logging of administered doses of prescribed diabetes medications and BGM and providing dosing and measurement reminders. | Device | My Dose Coach (Insulin Dosing Support App) |
| Standard Insulin Therapy EducationStandard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training. | Behavioural | My Dose Coach (Insulin Dosing Support App), Usual Care Group |
Primary outcome
Change From Baseline in Glycemic Control at 3 Months
Time frame: Baseline to 3 months
Average change in hemoglobin A1c from baseline to 3 months
14 secondary outcomes
Change From Baseline in Fasting Blood Glucose at 3 Months
Time frame: Baseline to 3 months
Change From Baseline in Fasting Blood Glucose at 6 Months
Time frame: Baseline to 6 months
Change From 3 Months in Fasting Blood Glucose at 6 Months
Time frame: Months 3 to 6
Change From Baseline in Hemoglobin A1c at 6 Months
Time frame: Baseline to 6 months
Change From 3 Months in Hemoglobin A1c at 6 Months
Time frame: Months 3 to 6
Proportion of Patients Who Achieve Glycemic Targets
Time frame: 3 months
Proportion of Patients Who Maintain Glycemic Targets
Time frame: 6 months
Change From Baseline in Diabetes Distress at 3 Months
Time frame: Baseline to 3 months
Change From Baseline in Diabetes Distress at 6 Months
Time frame: Baseline to 6 months
Change From 3 Months in Diabetes Distress at 6 Months
Time frame: Month 3 to month 6
Participant Acceptability of Insulin Dosing Support System for Insulin Titration
Time frame: 3 months
Participant Satisfaction With Insulin Treatment
Time frame: 6 months
Number of Hypoglycemic Events
Time frame: As reported across study period, up to 6 months
Number of Participants Who Experienced Severe Hypoglycemic Events.
Time frame: As reported across study period, up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 15735199Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
- Results publication: PubMed 22228744Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6.
- Results publication: PubMed 24673614Peyrot M, Xu Y, Rubin RR. Development and validation of the Diabetes Medication System Rating Questionnaire-Short Form. Diabet Med. 2014 Oct;31(10):1237-44. doi: 10.1111/dme.12453. Epub 2014 Apr 18.
- Individual participant dataSharing planned: Yes. A consent form used in enrolling participants will be posted.
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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.
Linda Siminerio, RN, PhD, CDE principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone application and web portal and Standard Insulin Therapy Education in people with Diabetes Mellitus Type 2 - Insulin-Treated, run by Linda Siminerio at 1 site in United States.
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 13 inclusion and 2 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: stopped early, as of the sponsor's last update on 14 Feb 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Glycemic Control at 3 Months (time frame: Baseline to 3 months). 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 NCT04678661, which also lists 3 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 14 Feb 2024.