Diabetes Mellitus, Type 2NCT04591015
Dulce Digital-COVID Aware (DD-CA) Discharge Texting Platform for US/Mexico Border Hispanics With Diabetes + COVID-19
A study testing Hospital: DD-CA in people with Diabetes Mellitus, Type 2 and Covid19, run by Scripps Whittier Diabetes Institute at 1 site in United States.
Trial summary
The COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor clinical outcomes when compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Covid19
- What is being tested?
- Hospital: DD-CA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 31 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are a patient admitted to a Scripps Mercy Hospital,
- Consider yourself Hispanic/Latino, of any race
- Are 18 years of age or older,
- Speak English or Spanish,
- Have type 2 diabetes and A1c ≥ 7% in the last 90 days, and
- Have a cellphone that can receive/send text messages.
Who cannot join
- Are pregnant,
- Are currently participating in another diabetes or COVID-19 related study, or
- Do not meet all eligibility inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Mercy Hospital Chula Vista
Chula Vista, California, 91910
About this study
The COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor clinical outcomes when compared to non-Hispanic populations. The supplemental Dulce Digital-COVID Aware (DD-CA) intervention addresses specific barriers in diverse underserved Hispanic and Latino communities to improve glucose control and lower transmission of COVID-19 during a highly vulnerable period post hospitalization discharge, to reduce hospital readmission rates. This supplement will integrate COVID educational messaging with glucose management messaging within a low-cost, easily adoptable digital texting platform and offer critical information in a culturally and linguistically relevant manner to address specific barriers in diverse underserved communities.
Read the detailed description
Hispanics, a group that shows higher type 2 diabetes (T2D) prevalence, and poor self-management and clinical outcomes, have been disproportionally adversely impacted by COVID-19. The California Department of Public Health reports that Hispanics make up 39% of California's population but an unprecedented 57% of the confirmed COVID-19 cases. This devastating finding is especially notable on the US/Mexico border. Diabetes has emerged as a leading risk factor for severe COVID-19 illness leading to hospitalization, is associated with greater disease severity and mortality and is an independent predictor of intensive care placement and invasive ventilation. It is becoming increasingly clear that maintaining good glucose control improves prognosis of COVID-19 among people with pre-existing T2D. However, social distancing, quarantine, and stay-at-home/lockdown guidelines may impact one's ability to maintain adequate glycemic control. Research is needed to evaluate the effect and clinical outcomes of a flexible, easily adopted low cost digital intervention that improves glucose excursions and provides urgently needed COVID-19 mitigation strategies, among rapidly rising groups of high-risk Hispanics with poorly controlled T2D in US/Mexico border communities. Strong evidence from our parent grant Dulce Digital-Me (DD-ME), supports the use of technology (such as text messaging) alone or in combination with coaching interventions as a viable and desired method of delivering tailored diabetes self-management education and COVID awareness messaging to high-risk, underserved populations in a manner that is more convenient for both patients and staff while having the added benefit of being cost-effective for health systems, especially within low resource settings. However, effective interventions may encounter barriers which preclude guaranteed success upon implementation in the real world. This project, taking place along the San Diego/Tijuana border, historically the busiest land port of entry in the Western Hemisphere, will assess the effect of providing an enhanced digital texting intervention-Dulce Digital-COVID Aware (DD-CA) to N = 172 Hispanic patients with T2D upon discharge from a recent hospitalization. Key outcomes will assess the impact of DD-CA on hospital readmissions at 30, 90 and 180 days post-discharge, glucose control and patient reported outcomes at 90 and 180 days post-discharge while also assessing COVID status and the implementation process. Given that DD-CA offers the potential to address many of the practical barriers to access and extend the reach of diabetes services, while additionally providing COVID awareness support, it offers an ideal low-cost and flexible solution to reduce hospital admissions and re-admissions in US/Mexico border communities significantly and simultaneously affected by COVID-19 and T2D. Implemented in a typical hospital and post-discharge setting, it augments existing care team processes, thus providing a valuable test of real-world effectiveness. More importantly, by helping to reduce existing inequities in access to diabetes and COVID-19 care, this program aims to improve health outcomes on a larger scale.
- Conditions
- Diabetes Mellitus, Type 2, Covid19
- Being tested
- Hospital: DD-CA, Hospital: Usual Care (UC)
- Keywords
- Type 2 Diabetes, COVID-19
- Medical subject headings
- Diabetes Mellitus, Type 2, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital: DD-CABehavioural
In the DD-CA group, participants will be offered a proven digital texting platform in their language of preference (Spanish/English) as part of the diabetes transitions discharge program with educational, motivational and medication adherence messaging that is currently an arm of our parent DD-ME grant with added COVID support messages that provide information addressing identified barriers in Hispanic underserved communities (e.g. obtaining testing supplies and medications, accessing routine medical care, and completing other important diabetes self-management behaviors such as healthful eating, exercise, social distancing, quarantine, and stay-at-home/lockdown guidelines).
Hospital: Usual Care (UC)Behavioural
In the UC group, participants will not receive the added COVID support messages, both groups will have a referral placed to the Diabetes Transitions Service (DTS) at the time of discharge as part of usual care. Participants will be contacted by a peer health coach following protocol to coordinate care with outpatient health and other community resources.
| Study group | Role | What they receive |
|---|---|---|
| DD-CA | Experimental | In the DD-CA arm, participants will be offered a proven digital texting platform in their language of preference (Spanish/English) as part of the diabetes transitions discharge program with added COVID support messages. Receives: Behavioral: Hospital: DD-CA |
| Usual Care (UC) | Active comparator | UC participants will not receive the added COVID support messages, both arms will have a referral placed to the Diabetes Transitions Service (DTS) as part of usual care at the time of discharge. Receives: Behavioral: Hospital: Usual Care (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Readmission Rate Within 30 Days of Discharge
Number of Participants With at Least 1 Hospital Readmission Within 30 Days After Enrollment, analyzed for full study sample
Measured: Within 30 days of discharge
Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 90 Days
Change in Glycosylated Hemoglobin (HbA1c) 90 days from baseline. A negative mean indicates positive change in HbA1c.
Measured: 90 days from baseline
Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 180 Days
Change in Glycosylated Hemoglobin (HbA1c) 180 days from baseline. A negative mean indicates positive change in HbA1c.
Measured: 180 days from baseline
Secondary outcomes (17)
Hospital Readmission Rate Within 90 Days of Discharge
Number of Participants With at Least 1 Hospital Readmission Within 90 Days After Enrollment, analyzed for full study sample.
Measured: Within 90 days of discharge
Diabetes Distress Scale - Change From Baseline to 90 Days
Diabetes distress as reported by patient; 90 days from baseline. The minimum score is 1 and maximum score is 6 with a higher score representing worse outcome or greater diabetes related emotional stress. A negative mean indicates a positive change in the diabetes distress score.
Measured: 90 days from baseline
Diabetes Distress Scale - Change From Baseline to 180 Days
Diabetes distress as reported by patient; 180 days from baseline. The minimum score is 1 and maximum score is 6 with a higher score representing worse outcome or greater diabetes-related emotional stress. A negative mean indicates a positive change in the diabetes distress score.
Measured: 180 days from baseline
Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 90 Days
Diabetes self-care activities related to Diet as reported by patient; 90 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes diet self-management behaviors. A positive mean indicates a positive change in the diet self-care activities.
Measured: 90 days from baseline
Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 90 Days
Diabetes self-care activities related to Exercise as reported by patient; 90 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes exercise self-management behaviors. A positive mean indicates a positive change in exercise self-care activities.
Measured: 90 days from baseline
Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 90 Days
Diabetes self-care activities related to Blood Sugar as reported by patient; 90 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes blood sugar self-management behaviors. A positive mean indicates a positive change in blood sugar self-care activities.
Measured: 90 days from baseline
Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 180 Days
Diabetes self-care activities related to Diet as reported by patient; 180 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes diet self-management behaviors. A positive mean indicates a positive change in diet self-care activities.
Measured: 180 days from baseline
Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 180 Days
Diabetes self-care activities related to Exercise as reported by patient; 180 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes exercise self-management behaviors. A positive mean indicates a positive change in exercise self-care activities.
Measured: 180 days from baseline
Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 180 Days
Diabetes self-care activities related to Blood Sugar as reported by patient; 180 days from baseline; The minimum score is 0 and maximum score is 7 with a higher score representing better adherence to diabetes blood sugar self-management behaviors. A positive mean indicates a positive change in blood sugar self-care activities.
Measured: 180 days from baseline
COVID-19 Patient Survey (Phenix Toolkit) Within 90 Days of Discharge
COVID-19 Patient Survey was used to assess COVID-19 diagnosis status and determine whether new infections occurred in the 90-day post-discharge time frame.
Measured: Within 90 days of discharge
COVID-19 Patient Survey (Phenix Toolkit) Within 180 Days of Discharge
COVID-19 Patient Survey was used to assess COVID-19 diagnosis status and determine whether new infections occurred in the 180-day post-discharge time frame.
Measured: Within 180 days of discharge
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 90 Days
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported physical health collected at baseline and 90 days. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 90 days, a positive mean indicates a better outcome/higher quality of life.
Measured: 90 days from baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 90 Days
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported mental health 90 days from baseline. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 90 days, a positive mean indicates a better outcome/higher quality of life and a negative mean indicates a worse outcome/lower quality of life.
Measured: 90 days from baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 180 Days
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported physical health 180 days from baseline. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 180 days, a positive mean indicates a better outcome/higher quality of life.
Measured: 180 days from baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 180 Days
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale was a measure of overall score patient-reported mental health 180 days from baseline. The minimum score on this scale is 0 and maximum score is 100. A higher score indicates a better outcome/higher quality of life. When the means are calculated between baseline and 180 days, a positive mean indicates a better outcome/higher quality of life, and a negative mean indicates a worse outcome/lower quality of life.
Measured: 180 days from baseline
Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 90 Days
Knowledge, Attitudes and Practice Toward COVID-19 Survey was used to measure knowledge and attitudes related to COVID-19 at 90 days from baseline. The minimum score on this scale is 0 and maximum score is 12, with higher scores indicating greater knowledge of COVID-19. A negative mean indicates lesser knowledge of COVID-19.
Measured: 90 days from baseline
Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 180 Days
Knowledge, Attitudes and Practice Toward COVID-19 Survey was used to measure knowledge and attitudes related to COVID-19 at 180 days from baseline. The minimum score on this scale is 0 and maximum score is 12, with higher scores indicating greater knowledge of COVID-19. A negative mean indicates lesser knowledge of COVID-19.
Measured: 180 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Feb 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
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.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Whittier Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Athena Philis-Tsimikas, Scripps Whittier Diabetes Institute
- Investigators
- Athena Philis-Tsimikas, MD, Principal investigator, Scripps Whittier Diabetes Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591015
- Sponsor's protocol ID
- 3R01DK112322-05S1
- Other IDs
- 3R01DK112322-05S1
- Status last verified
- Jun 2025
- First submitted
- 5 Oct 2020
- Last updated
- 18 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dulce Digital-COVID Aware (DD-CA) Discharge Texting Platform for US/Mexico Border Hispanics With Diabetes + COVID-19
- ClinicalTrials.gov ID
- NCT04591015
- Acronym / sponsor ID
- 3R01DK112322-05S1
- Conditions
- Diabetes Mellitus, Type 2, Covid19
- Keywords
- Type 2 Diabetes, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Scripps Whittier Diabetes InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The COVID-19 pandemic has triggered extremely high hospitalization rates where mitigation strategies are urgently necessary to aid vulnerable Hispanic and Latino populations who are experiencing health disparities as well as high type 2 diabetes (T2D) prevalence with poor clinical outcomes when compared to non-Hispanic populations. The supplemental Dulce Digital-COVID Aware (DD-CA) intervention addresses specific barriers in diverse underserved Hispanic and Latino communities to improve glucose control and lower transmission of COVID-19 during a highly vulnerable period post hospitalization discharge, to reduce hospital readmission rates. This supplement will integrate COVID educational messaging with glucose management messaging within a low-cost, easily adoptable digital texting platform and offer critical information in a culturally and linguistically relevant manner to address specific barriers in diverse underserved communities.
Detailed description
Hispanics, a group that shows higher type 2 diabetes (T2D) prevalence, and poor self-management and clinical outcomes, have been disproportionally adversely impacted by COVID-19. The California Department of Public Health reports that Hispanics make up 39% of California's population but an unprecedented 57% of the confirmed COVID-19 cases. This devastating finding is especially notable on the US/Mexico border. Diabetes has emerged as a leading risk factor for severe COVID-19 illness leading to hospitalization, is associated with greater disease severity and mortality and is an independent predictor of intensive care placement and invasive ventilation. It is becoming increasingly clear that maintaining good glucose control improves prognosis of COVID-19 among people with pre-existing T2D. However, social distancing, quarantine, and stay-at-home/lockdown guidelines may impact one's ability to maintain adequate glycemic control. Research is needed to evaluate the effect and clinical outcomes of a flexible, easily adopted low cost digital intervention that improves glucose excursions and provides urgently needed COVID-19 mitigation strategies, among rapidly rising groups of high-risk Hispanics with poorly controlled T2D in US/Mexico border communities. Strong evidence from our parent grant Dulce Digital-Me (DD-ME), supports the use of technology (such as text messaging) alone or in combination with coaching interventions as a viable and desired method of delivering tailored diabetes self-management education and COVID awareness messaging to high-risk, underserved populations in a manner that is more convenient for both patients and staff while having the added benefit of being cost-effective for health systems, especially within low resource settings. However, effective interventions may encounter barriers which preclude guaranteed success upon implementation in the real world. This project, taking place along the San Diego/Tijuana border, historically the busiest land port of entry in the Western Hemisphere, will assess the effect of providing an enhanced digital texting intervention-Dulce Digital-COVID Aware (DD-CA) to N = 172 Hispanic patients with T2D upon discharge from a recent hospitalization. Key outcomes will assess the impact of DD-CA on hospital readmissions at 30, 90 and 180 days post-discharge, glucose control and patient reported outcomes at 90 and 180 days post-discharge while also assessing COVID status and the implementation process. Given that DD-CA offers the potential to address many of the practical barriers to access and extend the reach of diabetes services, while additionally providing COVID awareness support, it offers an ideal low-cost and flexible solution to reduce hospital admissions and re-admissions in US/Mexico border communities significantly and simultaneously affected by COVID-19 and T2D. Implemented in a typical hospital and post-discharge setting, it augments existing care team processes, thus providing a valuable test of real-world effectiveness. More importantly, by helping to reduce existing inequities in access to diabetes and COVID-19 care, this program aims to improve health outcomes on a larger scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DD-CA | Experimental | Behavioral: Hospital: DD-CAIn the DD-CA arm, participants will be offered a proven digital texting platform in their language of preference (Spanish/English) as part of the diabetes transitions discharge program with added COVID support messages. |
| Usual Care (UC) | Active comparator | Behavioral: Hospital: Usual Care (UC)UC participants will not receive the added COVID support messages, both arms will have a referral placed to the Diabetes Transitions Service (DTS) as part of usual care at the time of discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are a patient admitted to a Scripps Mercy Hospital,
- Consider yourself Hispanic/Latino, of any race
- Are 18 years of age or older,
- Speak English or Spanish,
- Have type 2 diabetes and A1c ≥ 7% in the last 90 days, and
Key exclusion criteria (3 listed)
- Are pregnant,
- Are currently participating in another diabetes or COVID-19 related study, or
- Do not meet all eligibility inclusion criteria.
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 |
|---|---|---|
| Hospital: DD-CAIn the DD-CA group, participants will be offered a proven digital texting platform in their language of preference (Spanish/English) as part of the diabetes transitions discharge program with educational, motivational and medication adherence messaging that is currently an arm of our parent DD-ME grant with added COVID support messages that provide information addressing identified barriers in Hispanic underserved communities (e.g. obtaining testing supplies and medications, accessing routine medical care, and completing other important diabetes self-management behaviors such as healthful eating, exercise, social distancing, quarantine, and stay-at-home/lockdown guidelines). | Behavioural | DD-CA |
| Hospital: Usual Care (UC)In the UC group, participants will not receive the added COVID support messages, both groups will have a referral placed to the Diabetes Transitions Service (DTS) at the time of discharge as part of usual care. Participants will be contacted by a peer health coach following protocol to coordinate care with outpatient health and other community resources. | Behavioural | Usual Care (UC) |
Primary outcome
Hospital Readmission Rate Within 30 Days of Discharge
Time frame: Within 30 days of discharge
Number of Participants With at Least 1 Hospital Readmission Within 30 Days After Enrollment, analyzed for full study sample
Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 90 Days
Time frame: 90 days from baseline
Change in Glycosylated Hemoglobin (HbA1c) 90 days from baseline. A negative mean indicates positive change in HbA1c.
Glycosylated Hemoglobin (HbA1c) - Change From Baseline to 180 Days
Time frame: 180 days from baseline
Change in Glycosylated Hemoglobin (HbA1c) 180 days from baseline. A negative mean indicates positive change in HbA1c.
17 secondary outcomes
Hospital Readmission Rate Within 90 Days of Discharge
Time frame: Within 90 days of discharge
Diabetes Distress Scale - Change From Baseline to 90 Days
Time frame: 90 days from baseline
Diabetes Distress Scale - Change From Baseline to 180 Days
Time frame: 180 days from baseline
Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 90 Days
Time frame: 90 days from baseline
Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 90 Days
Time frame: 90 days from baseline
Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 90 Days
Time frame: 90 days from baseline
Summary of Diabetes Self-Care Activities - Diet - Change From Baseline to 180 Days
Time frame: 180 days from baseline
Summary of Diabetes Self-Care Activities - Exercise - Change From Baseline to 180 Days
Time frame: 180 days from baseline
Summary of Diabetes Self-Care Activities - Blood Sugar - Change From Baseline to 180 Days
Time frame: 180 days from baseline
COVID-19 Patient Survey (Phenix Toolkit) Within 90 Days of Discharge
Time frame: Within 90 days of discharge
COVID-19 Patient Survey (Phenix Toolkit) Within 180 Days of Discharge
Time frame: Within 180 days of discharge
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 90 Days
Time frame: 90 days from baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 90 Days
Time frame: 90 days from baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Physical - Change Between Baseline and 180 Days
Time frame: 180 days from baseline
Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Scale - Mental - Change Between Baseline and 180 Days
Time frame: 180 days from baseline
Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 90 Days
Time frame: 90 days from baseline
Knowledge, Attitudes and Practice Toward COVID-19 Survey - Change From Baseline to 180 Days
Time frame: 180 days from baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Athena Philis-Tsimikas, MD principal investigator
Scripps Whittier Diabetes Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital: DD-CA in people with Diabetes Mellitus, Type 2 and Covid19, run by Scripps Whittier Diabetes Institute 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 6 inclusion and 3 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 18 Jun 2025. 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 28 Sep 2023). 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?
Hospital Readmission Rate Within 30 Days of Discharge (time frame: Within 30 days of discharge). The study lists 3 primary outcomes in all. 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 18 Jun 2025.