Diabetes Mellitus, Type 2FREEDOMNCT05288452
Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
A study testing Digital Health Coaching, Food Box Delivery and Remote Patient Monitoring (RPM) in people with Diabetes Mellitus, Type 2, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Brief Summary: The FREEDOM study aims to develop a scalable intervention to improve type 2 diabetes mellitus control in low-income Black adults in the Deep South. The intervention targets social determinants of health (SDoH) such as reduced healthcare access, poverty, transportation barriers, and food insecurity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Digital Health Coaching, Food Box Delivery and Remote Patient Monitoring (RPM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 30 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified as Black/African American
- ICD diagnosis of T2DM
- ≥18 years of age
- Ongoing insulin treatment
- HbA1c ≥8% within 6 weeks of study screening
- has the ability to converse in and read English
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- must provide written informed consent prior to enrollment
- ≥ 18 years of age
- ICD diagnosis of T2DM
- HbA1c ≥ 7%
- Confirmed HIV+ diagnosis
- Prescribed HIV ART therapy as part of care
Who cannot join
- Current enrollment in any diabetes-related interventional study
- Cognitive impairment
- End-stage kidney disease (CKD-5)
- Pregnant or plans to become pregnant within 12 months
- Currently enrolled in a structured lifestyle change program
- Enrolled in remote patient monitoring or health coaching within 60 days of the study or intervention
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- HIV Cohort Criteria
- Current enrollment in any diabetes-related interventional study or structured lifestyle change program
- Enrolled in RPM or health coaching (except for coaching on smoking cessation) within 60 days of the intervention
- Cognitive impairment
- End-stage kidney disease (CKD-5)
- Pregnant or plans to become pregnant within 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Hospital and UMMC Cardiology Clinics
Birmingham, Alabama, 35205
About this study
Brief Summary:
The FREEDOM study aims to develop a scalable intervention to improve type 2 diabetes mellitus control in low-income Black adults in the Deep South. The intervention targets social determinants of health (SDoH) such as reduced healthcare access, poverty, transportation barriers, and food insecurity.
Read the detailed description
Detailed Description:
- FREEDOM Study (Type 2 Diabetes Mellitus): The FREEDOM study is a 12-month clinical trial enrolling 304 Black adults with Type 2 Diabetes Mellitus across three healthcare systems in Alabama and Mississippi. Participants are randomly assigned to one of eight combinations of three intervention components:
- Digital Health Coaching: Participants receive one-on-one phone-based coaching for optimized diabetes management.
- Food Box Delivery: Food boxes are delivered every two weeks to participants' homes,
- Remote Patient Monitoring (RPM): Participants receive essential supplies, including glucometers, for remote blood glucose measurement. Data is monitored remotely for timely interventions. The study involves three in-person visits at baseline, month 6, and month 12, as well as two telephone study check-ins at month 3 and 9. Survey packets are administered at each time point.
- FREEDOM-HIV Study (Type 2 Diabetes Mellitus and HIV Cohort):
Additionally, a cohort within the study, known as the FREEDOM-HIV study, will enroll additional 80 adults who have both Type 2 Diabetes Mellitus and HIV. This cohort will be observed over a 6-month period and will also consist of the same three intervention components.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Digital Health Coaching, Food Box Delivery, Remote Patient Monitoring (RPM), Diabetes Education Class
- Keywords
- Diabetes Mellitus, Type 2, HIV
- 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.
Digital Health CoachingBehavioural
The digital health coaching intervention program involves an evidence-based curriculum and one-on-one support to promote positive health behaviors and patient self-management of diabetes.
Food Box DeliveryDietary supplement
The food box intervention component will consist of biweekly food boxes delivered directly to participants over the course of 6 months. The food boxes will contain shelf-stable groceries that adhere to ADA nutritional guidelines for individuals with T2DM.
Remote Patient Monitoring (RPM)Behavioural
The RPM team will instruct the participants to monitor blood glucose levels 3 times daily. Glucose levels will be monitored 8 a.m. to 5 p.m.Monday to Friday. Data summaries will be reviewed bi-monthly with RNs and pharmacists. Participants will be provided with a glucometer, test strips, and mobile divide to record their blood glucose levels.
Diabetes Education ClassBehavioural
The diabetes education class will be administered by a certified diabetes educator.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Digital coaching+ Food delivery+ RPM Receives: Behavioral: Digital Health Coaching; Dietary Supplement: Food Box Delivery; Behavioral: Remote Patient Monitoring (RPM); Behavioral: Diabetes Education Class |
| Arm 2 | Active comparator | Digital coaching Receives: Behavioral: Digital Health Coaching; Behavioral: Diabetes Education Class |
| Arm 3 | Active comparator | Digital coaching+ Food delivery Receives: Behavioral: Digital Health Coaching; Dietary Supplement: Food Box Delivery; Behavioral: Diabetes Education Class |
| Arm 4 | Active comparator | Digital coaching+ RPM Receives: Behavioral: Digital Health Coaching; Behavioral: Remote Patient Monitoring (RPM); Behavioral: Diabetes Education Class |
| Arm 5 | Active comparator | Food delivery+ RPM Receives: Dietary Supplement: Food Box Delivery; Behavioral: Remote Patient Monitoring (RPM); Behavioral: Diabetes Education Class |
| Arm 6 | Active comparator | The participant's will not receive any Intervention Receives: Behavioral: Diabetes Education Class |
| Arm 7 | Active comparator | Food delivery Receives: Dietary Supplement: Food Box Delivery; Behavioral: Diabetes Education Class |
| Arm 8 | Active comparator | RPM Receives: Behavioral: Remote Patient Monitoring (RPM); Behavioral: Diabetes Education Class |
What is being measured
The primary outcome is the main question the study is designed to answer.
FREEDOM Study: Change in HbA1c level between baseline and 12 month
The primary outcome of the study is to track change in the HbA1c between baseline and 12 months (endpoint of the study). The HbA1C will be tested at baseline, 6 and 12 months.
Measured: 12 months
Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 6 months
The primary outcome of the study is to track change in the HbA1c between baseline and 6 months (endpoint of the study). The HbA1C will be tested at baseline and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start5 Jan 2023
- Primary completion21 Jul 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- We used the multiphase optimization strategy (MOST) as the ideal approach for the proposed study as, with the three proposed intervention components, identifying an optimal intervention through a single randomized controlled trial (RCT) with multiple arms or through multiple RCTs would be methodologically inefficient and resource-intensive. Given this, we rely on the eloquent and rigorous MOST-based optimization design, which leverages factorial experimentation to identify an optimal set of intervention component(s). In a factorial experiment, the goal is not to compare individual experimental conditions (in this case, eight conditions), but to use combinations of conditions to estimate the main and interaction effects of the intervention components. Thus, numerous intervention components can be evaluated simultaneously while utilizing the entire randomized sample.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mississippi Medical Center, Cooper Green Mercy Health Services, Pack Health, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Tapan Shirish Mehta, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288452
- Sponsor's protocol ID
- IRB-300008387
- Other IDs
- 5P50MD017338-03
- Acronym
- FREEDOM
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2022
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El Zein A, Garla V, Hall ME, Nawshin T, Hays D, John T, Delaney E, Wallace E, Hearld L, Cherrington AL, Mehta T. Rationale and design of the FREEDOM study: A hybrid type 1 optimization-implementation trial to improve type 2 diabetes management in primary care. Contemp Clin Trials. 2026 Feb;161:108173. doi: 10.1016/j.cct.2025.108173. Epub 2025 Dec 5.
PubMed 41354173
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Delivery, Remote Monitoring, and Coaching-Enhanced Education for Optimized Diabetes Management (FREEDOM)
- ClinicalTrials.gov ID
- NCT05288452
- Acronym / sponsor ID
- FREEDOM / IRB-300008387
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of Mississippi Medical Center, Cooper Green Mercy Health Services, Pack Health, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 21 Mar 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.
Brief Summary:
The FREEDOM study aims to develop a scalable intervention to improve type 2 diabetes mellitus control in low-income Black adults in the Deep South. The intervention targets social determinants of health (SDoH) such as reduced healthcare access, poverty, transportation barriers, and food insecurity.
Detailed description
Detailed Description:
- FREEDOM Study (Type 2 Diabetes Mellitus): The FREEDOM study is a 12-month clinical trial enrolling 304 Black adults with Type 2 Diabetes Mellitus across three healthcare systems in Alabama and Mississippi. Participants are randomly assigned to one of eight combinations of three intervention components:
- Digital Health Coaching: Participants receive one-on-one phone-based coaching for optimized diabetes management.
- Food Box Delivery: Food boxes are delivered every two weeks to participants' homes,
- Remote Patient Monitoring (RPM): Participants receive essential supplies, including glucometers, for remote blood glucose measurement. Data is monitored remotely for timely interventions. The study involves three in-person visits at baseline, month 6, and month 12, as well as two telephone study check-ins at month 3 and 9. Survey packets are administered at each time point.
- FREEDOM-HIV Study (Type 2 Diabetes Mellitus and HIV Cohort):
Additionally, a cohort within the study, known as the FREEDOM-HIV study, will enroll additional 80 adults who have both Type 2 Diabetes Mellitus and HIV. This cohort will be observed over a 6-month period and will also consist of the same three intervention components.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 8
- Model description
- We used the multiphase optimization strategy (MOST) as the ideal approach for the proposed study as, with the three proposed intervention components, identifying an optimal intervention through a single randomized controlled trial (RCT) with multiple arms or through multiple RCTs would be methodologically inefficient and resource-intensive. Given this, we rely on the eloquent and rigorous MOST-based optimization design, which leverages factorial experimentation to identify an optimal set of intervention component(s). In a factorial experiment, the goal is not to compare individual experimental conditions (in this case, eight conditions), but to use combinations of conditions to estimate the main and interaction effects of the intervention components. Thus, numerous intervention components can be evaluated simultaneously while utilizing the entire randomized sample.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Digital Health Coaching, Dietary Supplement: Food Box Delivery, Behavioral: Remote Patient Monitoring (RPM), Behavioral: Diabetes Education ClassDigital coaching+ Food delivery+ RPM |
| Arm 2 | Active comparator | Behavioral: Digital Health Coaching, Behavioral: Diabetes Education ClassDigital coaching |
| Arm 3 | Active comparator | Behavioral: Digital Health Coaching, Dietary Supplement: Food Box Delivery, Behavioral: Diabetes Education ClassDigital coaching+ Food delivery |
| Arm 4 | Active comparator | Behavioral: Digital Health Coaching, Behavioral: Remote Patient Monitoring (RPM), Behavioral: Diabetes Education ClassDigital coaching+ RPM |
| Arm 5 | Active comparator | Dietary Supplement: Food Box Delivery, Behavioral: Remote Patient Monitoring (RPM), Behavioral: Diabetes Education ClassFood delivery+ RPM |
| Arm 6 | Active comparator | Behavioral: Diabetes Education ClassThe participant's will not receive any Intervention |
| Arm 7 | Active comparator | Dietary Supplement: Food Box Delivery, Behavioral: Diabetes Education ClassFood delivery |
| Arm 8 | Active comparator | Behavioral: Remote Patient Monitoring (RPM), Behavioral: Diabetes Education ClassRPM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Self-identified as Black/African American
- ICD diagnosis of T2DM
- ≥18 years of age
- Ongoing insulin treatment
- HbA1c ≥8% within 6 weeks of study screening
Key exclusion criteria (12 listed)
- Current enrollment in any diabetes-related interventional study
- Cognitive impairment
- End-stage kidney disease (CKD-5)
- Pregnant or plans to become pregnant within 12 months
- Currently enrolled in a structured lifestyle change program
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 Health CoachingThe digital health coaching intervention program involves an evidence-based curriculum and one-on-one support to promote positive health behaviors and patient self-management of diabetes. | Behavioural | Arm 1, Arm 2, Arm 3, Arm 4 |
| Food Box DeliveryThe food box intervention component will consist of biweekly food boxes delivered directly to participants over the course of 6 months. The food boxes will contain shelf-stable groceries that adhere to ADA nutritional guidelines for individuals with T2DM. | Dietary supplement | Arm 1, Arm 3, Arm 5, Arm 7 |
| Remote Patient Monitoring (RPM)The RPM team will instruct the participants to monitor blood glucose levels 3 times daily. Glucose levels will be monitored 8 a.m. to 5 p.m.Monday to Friday. Data summaries will be reviewed bi-monthly with RNs and pharmacists. Participants will be provided with a glucometer, test strips, and mobile divide to record their blood glucose levels. | Behavioural | Arm 1, Arm 4, Arm 5, Arm 8 |
| Diabetes Education ClassThe diabetes education class will be administered by a certified diabetes educator. | Behavioural | Arm 1, Arm 2, Arm 3, Arm 4, Arm 5, Arm 6, Arm 7, Arm 8 |
Primary outcome
FREEDOM Study: Change in HbA1c level between baseline and 12 month
Time frame: 12 months
The primary outcome of the study is to track change in the HbA1c between baseline and 12 months (endpoint of the study). The HbA1C will be tested at baseline, 6 and 12 months.
Primary Outcome for the HIV Cohort: Change in HbA1c level between baseline and 6 months
Time frame: 6 months
The primary outcome of the study is to track change in the HbA1c between baseline and 6 months (endpoint of the study). The HbA1C will be tested at baseline and 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Derived from this study: PubMed 41354173El Zein A, Garla V, Hall ME, Nawshin T, Hays D, John T, Delaney E, Wallace E, Hearld L, Cherrington AL, Mehta T. Rationale and design of the FREEDOM study: A hybrid type 1 optimization-implementation trial to improve type 2 diabetes management in primary care. Contemp Clin Trials. 2026 Feb;161:108173. doi: 10.1016/j.cct.2025.108173. Epub 2025 Dec 5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Health Coaching, Food Box Delivery and Remote Patient Monitoring (RPM) in people with Diabetes Mellitus, Type 2, run by University of Alabama at Birmingham 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 12 inclusion and 12 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: finished, as of the sponsor's last update on 22 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
FREEDOM Study: Change in HbA1c level between baseline and 12 month (time frame: 12 months). The study lists 2 primary outcomes in all. 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 NCT05288452, which also lists 1 linked publication.
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 22 Sep 2026.