DiabetesNCT04277117
Meals for Me: Drop Shipment Versus Personally-delivered Meals for Diabetes Management
A study testing Waitlist, Medically tailored meals - Daily delivery with human interaction and Medically tailored meals - Weekly delivery with no human interaction in people with Diabetes, run by University of Texas at Austin at 2 sites in United States.
Trial summary
This is a three-arm, parallel randomized trial study that will assess the impact of home delivery of medically-tailored meals (MTM) to community-dwelling older adults living with diabetes mellitus type 2 on measurements of diabetes control, mental health, and other exploratory outcomes such as healthcare use. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Waitlist, Medically tailored meals - Daily delivery with human interaction and Medically tailored meals - Weekly delivery with no human interaction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Dec 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 55-90
- Hemoglobin A1c ≥7.5%
- Living in Austin city limits and within a MOWCTX daily delivery route
- Interested and available to receive meals during delivery window time
- Has access to a freezer and a microwave
- Pass a MOWCTX background check
Who cannot join
- Participated in MOW program in previous 3 months.
- Has any of the following: dementia or cognitive impairment, diagnosis of heart failure, cirrhosis, or active cancer
- Is receiving hospice care
- Does not pass a MOWCTX background check
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Meals on Wheels Central Texas
Austin, Texas, 78702
CommUnityCare Health Centers (all Austin clinics)
Austin, Texas, 78741
About this study
Official title: Meals for Me: Drop Shipment Versus Personally Delivered Medically Tailored Meals for Patients With Unmanaged Diabetes.
This is a three-arm, parallel randomized trial study that will assess the impact of home delivery of medically-tailored meals (MTM) to community-dwelling older adults living with diabetes mellitus type 2 on measurements of diabetes control, mental health, and other exploratory outcomes such as healthcare use.
Read the detailed description
This study aims to:
- Assess the impact of medically-tailored meals program on diabetes management and mental health in comparison to usual care without such program.
- Assess the differential impact of two delivery models being considered for payment by the health system on diabetes management and mental health: once-a-week frozen drop shipment model versus daily warm meal delivery model that is more complex to implement but allows for human connection and easier meal preparation.
Implementation of program:
Meals on Wheels (MoW) of Central Texas (MOWCTX) in Austin, Texas, will provide the meals and delivery service in this study. Meals are all medically tailored (diabetes friendly) and design by MOWCT's team of Registered Dietitians.
Participants:
Older adults, 55 and over, living in the Austin city limits with poorly controlled diabetes; Inclusion criteria:
- Adult 55-90
- Hemoglobin A1C >=7.5 (as measured at baseline)
- Living in Austin city limits and within a MOWCTX daily delivery route
- Interested and available to receive meals during delivery window time
- Has access to a freezer and a microwave
- Pass a MOWCTX background check
Trial:
Eligible participants will be recruited from selected Federally Qualified Health Centers in the Austin area, MOWCTX clients on waitlist, and other (e.g. Medicaid recipients).
Participants will be randomized to one of three arms: 1) Waitlisted control; 2) Weekly frozen drop shipment of MTM 3) Daily Warm delivery of MTM with in-person check-ins during delivery.
Phase 1 (first 6 months) The intervention arms will receive their assigned method of meal delivery (weekly frozen or daily warm), for a total of 10 meals a week, including two main meals per day and snacks. The control arm will not receive any meals during this phase. All arms will receive printed educational materials at baseline.
Phase 2 (month 6 to 12) All arms will receive 2-4 meals a week (depending on participant's availability) delivered via the traditional meal services from MOWCTX, which includes one hot meal plus a snack delivered daily. Meal delivery can also include 1 or more frozen meals to account for a total of 5 meals per week.
Primary outcome is Hemoglobin A1C and secondary outcomes include depression as measured by PHQ-8 and other mental health measures.
- Conditions
- Diabetes
- Being tested
- Waitlist, Medically tailored meals - Daily delivery with human interaction, Medically tailored meals - Weekly delivery with no human interaction, Medically tailored meals - Standard MOWCTX delivery with human interaction
- Keywords
- Food as Medicine, Medically tailored meals, Chronic Disease, Food Insecurity, Food Home Delivery, Implementation Science
- Medical subject headings
- Diabetes Mellitus, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaitlistBehavioural
Phase 1 (6 months)
- Educational materials on such topics as healthy eating for diabetes.
Medically tailored meals - Daily delivery with human interactionBehavioural
Phase 1 (6 months)
- Educational materials on such topics as healthy eating for diabetes, in addition to materials on meal planning and instructions.
- Food: 10 MTM a week: mix of hot and frozen, and 5-10 snacks per week. Meals and snacks offer approx. 1200 kcal per day.
- Delivery: 3 to 5x per week. Each delivery day, one meal is warm, the other is frozen. Depending on the participant's availability (3-5 days/week), more frozen meals will be given one day to account for a total of 10 meals every week.
- Engagement: MOWCTX's trained volunteers and/or paid delivery drivers delivering the meals will have a brief social interaction (at minimum in-person hand-off \& visual check) with the participant.
Medically tailored meals - Weekly delivery with no human interactionBehavioural
Phase 1 (6 months)
- Educational materials on such topics as healthy eating for diabetes, in addition to materials on meal planning and instructions.
- Food: 10 frozen MTM and 5-10 healthy snacks (with the goal of providing 2 meals and 1-2 snacks for 5 days of the week). Meals and snacks offer approx. 1200 kcal per day. Nutritionally similar and frequently the same meal as that delivered in the daily delivery arm.
- Delivery: 1x per week shipment.
- Engagement: Meals are shipped to the participant's home. No human engagement.
Medically tailored meals - Standard MOWCTX delivery with human interactionBehavioural
Phase 2 (6 months)
- Food: 5 MTM a week plus snacks. Planned to offer approx. 600 kcal per day.
- Delivery: 2 to 4x a week (depending on participant availability), including daily delivery of 1 hot MTM plus a cold bag (with healthy snacks), with one day or more (depending on the 2 to 4x a week delivery schedule participant is on) also including 1 frozen MTM to total 5 meals per week.
- Engagement: MOWCTX's trained volunteers and/or paid delivery drivers delivering the meals will have a brief social interaction ("check-in") with the participant.
- MOWCTX Standard Wraparounds: Participants will have access to a case manager to assist with additional resources within the community and for additional support if needed (e.g., grocery shopping assistance, home repairs, and pet care).
| Study group | Role | What they receive |
|---|---|---|
| Waitlisted control | Other | Phase 1 (6 months, months 1-6):
* Educational materials on healthy eating for diabetes
* No meal delivery
Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week Receives: Behavioral: Waitlist; Behavioral: Medically tailored meals - Standard MOWCTX delivery with human interaction |
| "Daily Warm" MTM in-person delivery | Experimental | Phase 1 (6 months, months 1-6):
* Educational materials on healthy eating for diabetes
* 10 medically-tailored meals (MTM) per week, delivered 3-5x per week Mon-Fri
* Each delivery day, 1 hot and 1 frozen + snack delivered to the participant's home by trained volunteers and/or paid delivery drivers who provide human interaction. Depending on the participant's availability (3-5 days/week), more frozen meals will be given one day to account for a total of 10 meals every week.
Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week Receives: Behavioral: Medically tailored meals - Daily delivery with human interaction; Behavioral: Medically tailored meals - Standard MOWCTX delivery with human interaction |
| "Weekly Frozen" MTM drop shipment | Experimental | Phase 1 (6 months, months 1-6):
* Educational materials on healthy eating for diabetes
* 10 medically-tailored meals (MTM) delivered once a week
* Each week all meals are frozen.
* Meals are shipped to the participant's home with no human interaction
Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week. Receives: Behavioral: Medically tailored meals - Weekly delivery with no human interaction; Behavioral: Medically tailored meals - Standard MOWCTX delivery with human interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1C (HbA1c)
Finger stick point-of-care portable device.
Measured: Baseline to 6 months
Secondary outcomes (13)
Change in Hemoglobin A1C
Finger stick point-of-care portable device.
Measured: Baseline to 9 &12 months, 6 months to 12 months.
Program meal consumption
For frozen and warm meals, self-report on what was actually consumed (customized survey)
Measured: 6 months, 12 months
Diet quality as assessed by NHANES DSQ
Self-report of food consumption patterns
Measured: 6 months, 12 months
Loneliness as assessed by scores on the 3-item UCLA Loneliness Scale
Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness.
Measured: 6 months, 12 months
Depressive symptoms as assessed by scores on the the 8-item Depression Health Questionnaire (PHQ-8)
Respondents answer to eight questions that reflect the DSM-IV diagnosis criteria of depressive disorders. These questions ask how often in the past 2 weeks the respondent had experienced a particular depressive symptom. Each answer is scored from 0 to 3 and then summed. Total scores go from 0 and 24 points, with higher scores indicating greater depressive symptoms.
Measured: 6 months, 12 months
Anxiety symptoms as assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)
Investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to measure anxiety. Scored from 0-3, and a score of 0 indicates lower levels of anxiety while a score of 3 indicates higher levels of anxiety.
Measured: 6 months
Diabetes Self-Efficacy as assessed by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item
Respondents are asked to score their level of confidence (scale from 1, not at all confident, to 10, totally confident) at the present time in doing tasks related to diabetes management (e.g., diet behavior, physical activity, measuring blood glycemia and others). Higher scores indicate higher self-efficacy.
Measured: 6 months, 12 months
Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form
Self-reported with a 30-day lookback period. The sum of affirmative responses to the six questions in the module is the household's raw score on the scale. Higher scores indicate greater food insecurity.
Measured: 6 months, 12 months
Health Status and Quality of Life as assessed by scores on Short-form 12-item (SF-12)
Measures physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health.
Measured: 6 months, 12 months
Healthcare delay due to cost
Self-report of delaying healthcare due to cost. 1 item.
Measured: 6 months, 12 months
Emergency room visits
Self-report of going to a hospital emergency room.
Measured: 6 months, 12 months
Food-basic needs trade-offs (3 items)
Self-report of trading off paying for food vs. paying for medicine or medical care, for utilities, and for housing
Measured: 6 months, 12 months
Medication underuse due to cost (2 items)
Self-report of not acquiring a prescribed medication or took reduce dosage due to cost.
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start5 Dec 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Community-based trial randomized on a 2:3:3 ratio
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Meals on Wheels Central Texas
- Responsible party
- Principal investigator, Maninder Kahlon, University of Texas at Austin
- Investigators
- Maninder K Kahlon, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277117
- Sponsor's protocol ID
- STUDY00002808-2022
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2020
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meals for Me: Drop Shipment Versus Personally Delivered Medically Tailored Meals for Patients With Unmanaged Diabetes.
- ClinicalTrials.gov ID
- NCT04277117
- Acronym / sponsor ID
- STUDY00002808-2022
- Conditions
- Diabetes
- Keywords
- Food as Medicine, Medically tailored meals, Chronic Disease, Food Insecurity, Food Home Delivery, Implementation Science
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Meals on Wheels Central Texas
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Feb 2020 (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.
This is a three-arm, parallel randomized trial study that will assess the impact of home delivery of medically-tailored meals (MTM) to community-dwelling older adults living with diabetes mellitus type 2 on measurements of diabetes control, mental health, and other exploratory outcomes such as healthcare use.
Detailed description
This study aims to:
- Assess the impact of medically-tailored meals program on diabetes management and mental health in comparison to usual care without such program.
- Assess the differential impact of two delivery models being considered for payment by the health system on diabetes management and mental health: once-a-week frozen drop shipment model versus daily warm meal delivery model that is more complex to implement but allows for human connection and easier meal preparation.
Implementation of program:
Meals on Wheels (MoW) of Central Texas (MOWCTX) in Austin, Texas, will provide the meals and delivery service in this study. Meals are all medically tailored (diabetes friendly) and design by MOWCT's team of Registered Dietitians.
Participants:
Older adults, 55 and over, living in the Austin city limits with poorly controlled diabetes; Inclusion criteria:
- Adult 55-90
- Hemoglobin A1C >=7.5 (as measured at baseline)
- Living in Austin city limits and within a MOWCTX daily delivery route
- Interested and available to receive meals during delivery window time
- Has access to a freezer and a microwave
- Pass a MOWCTX background check
Trial:
Eligible participants will be recruited from selected Federally Qualified Health Centers in the Austin area, MOWCTX clients on waitlist, and other (e.g. Medicaid recipients).
Participants will be randomized to one of three arms: 1) Waitlisted control; 2) Weekly frozen drop shipment of MTM 3) Daily Warm delivery of MTM with in-person check-ins during delivery.
Phase 1 (first 6 months) The intervention arms will receive their assigned method of meal delivery (weekly frozen or daily warm), for a total of 10 meals a week, including two main meals per day and snacks. The control arm will not receive any meals during this phase. All arms will receive printed educational materials at baseline.
Phase 2 (month 6 to 12) All arms will receive 2-4 meals a week (depending on participant's availability) delivered via the traditional meal services from MOWCTX, which includes one hot meal plus a snack delivered daily. Meal delivery can also include 1 or more frozen meals to account for a total of 5 meals per week.
Primary outcome is Hemoglobin A1C and secondary outcomes include depression as measured by PHQ-8 and other mental health measures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Community-based trial randomized on a 2:3:3 ratio
| Arm | Type | Receives |
|---|---|---|
| Waitlisted control | Other | Behavioral: Waitlist, Behavioral: Medically tailored meals - Standard MOWCTX delivery with human interactionPhase 1 (6 months, months 1-6): * Educational materials on healthy eating for diabetes * No meal delivery Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week |
| "Daily Warm" MTM in-person delivery | Experimental | Behavioral: Medically tailored meals - Daily delivery with human interaction, Behavioral: Medically tailored meals - Standard MOWCTX delivery with human interactionPhase 1 (6 months, months 1-6): * Educational materials on healthy eating for diabetes * 10 medically-tailored meals (MTM) per week, delivered 3-5x per week Mon-Fri * Each delivery day, 1 hot and 1 frozen + snack delivered to the participant's home by trained volunteers and/or paid delivery drivers who provide human interaction. Depending on the participant's availability (3-5 days/week), more frozen meals will be given one day to account for a total of 10 meals every week. Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week |
| "Weekly Frozen" MTM drop shipment | Experimental | Behavioral: Medically tailored meals - Weekly delivery with no human interaction, Behavioral: Medically tailored meals - Standard MOWCTX delivery with human interactionPhase 1 (6 months, months 1-6): * Educational materials on healthy eating for diabetes * 10 medically-tailored meals (MTM) delivered once a week * Each week all meals are frozen. * Meals are shipped to the participant's home with no human interaction Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult 55-90
- Hemoglobin A1c ≥7.5%
- Living in Austin city limits and within a MOWCTX daily delivery route
- Interested and available to receive meals during delivery window time
- Has access to a freezer and a microwave
Key exclusion criteria (4 listed)
- Participated in MOW program in previous 3 months.
- Has any of the following: dementia or cognitive impairment, diagnosis of heart failure, cirrhosis, or active cancer
- Is receiving hospice care
- Does not pass a MOWCTX background check
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 |
|---|---|---|
| WaitlistPhase 1 (6 months) • Educational materials on such topics as healthy eating for diabetes. | Behavioural | Waitlisted control |
| Medically tailored meals - Daily delivery with human interactionPhase 1 (6 months) * Educational materials on such topics as healthy eating for diabetes, in addition to materials on meal planning and instructions. * Food: 10 MTM a week: mix of hot and frozen, and 5-10 snacks per week. Meals and snacks offer approx. 1200 kcal per day. * Delivery: 3 to 5x per week. Each delivery day, one meal is warm, the other is frozen. Depending on the participant's availability (3-5 days/week), more frozen meals will be given one day to account for a total of 10 meals every week. * Engagement: MOWCTX's trained volunteers and/or paid delivery drivers delivering the meals will have a brief social interaction (at minimum in-person hand-off \& visual check) with the participant. | Behavioural | "Daily Warm" MTM in-person delivery |
| Medically tailored meals - Weekly delivery with no human interactionPhase 1 (6 months) * Educational materials on such topics as healthy eating for diabetes, in addition to materials on meal planning and instructions. * Food: 10 frozen MTM and 5-10 healthy snacks (with the goal of providing 2 meals and 1-2 snacks for 5 days of the week). Meals and snacks offer approx. 1200 kcal per day. Nutritionally similar and frequently the same meal as that delivered in the daily delivery arm. * Delivery: 1x per week shipment. * Engagement: Meals are shipped to the participant's home. No human engagement. | Behavioural | "Weekly Frozen" MTM drop shipment |
| Medically tailored meals - Standard MOWCTX delivery with human interactionPhase 2 (6 months) * Food: 5 MTM a week plus snacks. Planned to offer approx. 600 kcal per day. * Delivery: 2 to 4x a week (depending on participant availability), including daily delivery of 1 hot MTM plus a cold bag (with healthy snacks), with one day or more (depending on the 2 to 4x a week delivery schedule participant is on) also including 1 frozen MTM to total 5 meals per week. * Engagement: MOWCTX's trained volunteers and/or paid delivery drivers delivering the meals will have a brief social interaction ("check-in") with the participant. * MOWCTX Standard Wraparounds: Participants will have access to a case manager to assist with additional resources within the community and for additional support if needed (e.g., grocery shopping assistance, home repairs, and pet care). | Behavioural | "Daily Warm" MTM in-person delivery, "Weekly Frozen" MTM drop shipment, Waitlisted control |
Primary outcome
Change in Hemoglobin A1C (HbA1c)
Time frame: Baseline to 6 months
Finger stick point-of-care portable device.
13 secondary outcomes
Change in Hemoglobin A1C
Time frame: Baseline to 9 &12 months, 6 months to 12 months.
Program meal consumption
Time frame: 6 months, 12 months
Diet quality as assessed by NHANES DSQ
Time frame: 6 months, 12 months
Loneliness as assessed by scores on the 3-item UCLA Loneliness Scale
Time frame: 6 months, 12 months
Depressive symptoms as assessed by scores on the the 8-item Depression Health Questionnaire (PHQ-8)
Time frame: 6 months, 12 months
Anxiety symptoms as assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)
Time frame: 6 months
Diabetes Self-Efficacy as assessed by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item
Time frame: 6 months, 12 months
Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form
Time frame: 6 months, 12 months
Health Status and Quality of Life as assessed by scores on Short-form 12-item (SF-12)
Time frame: 6 months, 12 months
Healthcare delay due to cost
Time frame: 6 months, 12 months
Emergency room visits
Time frame: 6 months, 12 months
Food-basic needs trade-offs (3 items)
Time frame: 6 months, 12 months
Medication underuse due to cost (2 items)
Time frame: 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- 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.
Maninder K Kahlon, PhD principal investigator
University of Texas at Austin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Waitlist, Medically tailored meals - Daily delivery with human interaction and Medically tailored meals - Weekly delivery with no human interaction in people with Diabetes, run by University of Texas at Austin at 2 sites 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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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 in Hemoglobin A1C (HbA1c) (time frame: Baseline to 6 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 21 Sep 2026.