TelemedicinePRACTICE-DMNCT03520413
Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus
A study testing PRACTICE-DM and Standard VA Home Telehealth in people with Telemedicine, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
Diabetes generates significant morbidity, mortality, and costs within the Veterans Health Administration (VHA). Veterans with persistently poor diabetes control despite clinic-based care are among the highest-risk diabetes patients in VHA, and contribute disproportionately to VHA's massive burden of diabetes… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Telemedicine
- What is being tested?
- PRACTICE-DM and Standard VA Home Telehealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Dec 2018to 1 Feb 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans with persistently poorly-controlled type 2 diabetes mellitus defined as the presence of 2 HbA1c values 8.5% during the prior year (none <8.5%) despite 1 or more appointments with a VHA Primary Care Provider (PCP) or Endocrinology during this period.
Who cannot join
- age >70
- life expectancy <5 years, or other comorbidities that would offset the benefits of HbA1c <8.5%
- inability to communicate by telephone
- dementia or psychosis
- active alcohol/substance disorder
- pregnancy
Show all 14Show fewer
- prior hypoglycemic seizure/coma
- refusal to perform self-monitored blood glucose (SMBG)
- use of insulin infusion pumps
- hospitalized for stroke, heart attack or had surgery for blocked arteries in the past 12m
- receiving kidney dialysis
- metastatic cancer diagnosis
- use of a continuous blood glucose monitor (due to HT equipment constraints)
- primary provider requests patient not participate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, 23249-0001
About this study
Official title: Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus (PRACTICE-DM)
Diabetes generates significant morbidity, mortality, and costs within the Veterans Health Administration (VHA). Veterans with persistently poor diabetes control despite clinic-based care are among the highest-risk diabetes patients in VHA, and contribute disproportionately to VHA's massive burden of diabetes complications and costs. VHA critically needs effective, practical management alternatives for Veterans whose diabetes does not respond to clinic-based management. The proposed study will address this need by leveraging VHA's unique Home Telehealth capacity to deliver comprehensive telemedicine-based management for Veterans with persistently poor diabetes control despite clinic-based care. Because this intensive intervention is delivered using only existing Home Telehealth workforce, infrastructure, and technical resources - which are ubiquitous at VHA centers nationwide - it could represent an effective, practical approach to improving outcomes in Veterans with PPDM, potentially translating to a substantial reduction in VHA's diabetes burden.
Read the detailed description
This study will evaluate a comprehensive telemedicine intervention for Veterans with persistently poor diabetes control despite clinic-based Veterans Health Administration (VHA) care. Because this approach is designed for delivery via existing Home Telehealth (HT) services, which are ubiquitous throughout VHA, it may represent an effective, practical alternative for Veterans whose diabetes is refractory to clinic-based care.
Although efforts by clinicians and researchers have improved diabetes control across VHA, Veterans with persistent poorly-controlled diabetes mellitus (PPDM) have not benefitted from these advances. The investigators define PPDM as maintenance of a hemoglobin A1c (HbA1c) 8.5% for >1 year, despite receiving clinic-based diabetes care during this period. Veterans meeting this definition - approximately 12% of all Veterans with type 2 diabetes - contribute disproportionately to VHA's burden of diabetes complications and costs.
While clinic-based care is insufficiently effective in PPDM, telemedicine-based management that comprehensively addresses factors underlying poor diabetes control could improve outcomes for these high-risk Veterans. Unfortunately, healthcare systems have rarely integrated comprehensive telemedicine-based care into real-world practice, even for clinic-refractory conditions like PPDM. This gap stems from the fact that comprehensive telemedicine-based diabetes care has not previously been designed for practical delivery under real-world conditions. In order for telemedicine to fulfill its potential as a means to reduce the burden of PPDM, interventions must be developed with an emphasis on feasible delivery through existing workforce, infrastructure, and technical resources, such that effective implementation is eventually achievable. Until then, Veterans with PPDM will be left without alternatives when clinic-based care proves inadequate.
The proposed trial will evaluate Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM), a novel, comprehensive telemedicine intervention for PPDM that is designed for practical delivery within VHA. The Specific Aims of this study are to: 1) determine PRACTICE-DM's effectiveness; 2) evaluate PRACTICE-DM's acceptability and mechanisms of effect using a mixed method process evaluation; and 3) understand costs associated with PRACTICE-DM.
Two hundred Veterans with PPDM from two sites (Durham, North Carolina (NC) and Richmond, Virginia (VA)) will be randomized to receive one of two HT-delivered interventions: 1) PRACTICE-DM, a comprehensive intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression support; or 2) an active control, standard HT care coordination and telemonitoring. Both interventions will be delivered over a 12-month period and all participants will continue to receive usual VHA care.
The primary study outcome will be change in HbA1c from study baseline to 12 months. The secondary outcomes are guided by a theoretical framework, and will include diabetes self-care, diabetes burden, self-efficacy, and depressive symptoms. Qualitative interviews will be conducted with 20 intervention-group Veterans, the HT nurses delivering the intervention, and administrators at each site. Intervention costs will be comprehensively assessed and compared to standard HT care coordination and telemonitoring.
Although VHA is a leader in telemedicine, its telemedicine capabilities are currently underutilized for Veterans with PPDM. These Veterans are refractory to clinic-based care, so contribute disproportionately to diabetes complications and costs. This study will leverage VHA's unique telemedicine infrastructure to deliver comprehensive management designed for PPDM, with the goal of improving outcomes in this high-risk, high cost population. Because the proposed intervention is designed for delivery using existing HT services, it may represent an effective, practical approach to reducing the burden of poor diabetes control across VHA.
- Conditions
- Telemedicine
- Being tested
- PRACTICE-DM, Standard VA Home Telehealth
- Keywords
- Complex Care, Outcomes, Telemedicine, Rural Health, Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRACTICE-DMOther
Five-component diabetes intervention: 1) telemonitoring; 2) self-management support; 3) diet/activity support; 4) medication management; and 5) depression support.
Standard VA Home TelehealthOther
Standard VA HT care coordination and telemonitoring.
| Study group | Role | What they receive |
|---|---|---|
| PRACTICE-DM | Experimental | PRACTICE-DM is a comprehensive telemedicine intervention that bundles telemonitoring, self-management support, diet/activity support, medication management, and depression support - each of which targets a critical factor underlying PPDM - into a single, comprehensive program specifically developed for practical delivery using existing VHA Home Telehealth (HT) workforce, infrastructure, and technical resources. Receives: Other: PRACTICE-DM |
| Standard VA Home Telehealth | Active comparator | Standard VA HT care coordination and telemonitoring. Receives: Other: Standard VA Home Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Laboratory blood test to measure diabetes control
Measured: 12 months
Secondary outcomes (5)
Diabetes Distress Scale
Measure of diabetes distress and burden using the Diabetes Distress Scale (DDS). 17 items, Scale 1-6. Scoring: Average. Higher score indicates higher distress level.
Measured: 12 months
Diabetes Self-Management Questionnaire
Measure of diabetes self-care. Diabetes Self-Management Questionnaire (DSMQ). 16 items, Scale 0-3. Scoring: Sum and transform to fall between 0-10. Higher score indicates more effective self-care.
Measured: 12 months
Perceived Competence Scale
Measure of diabetes self-efficacy and capacity. Perceived Competence Scale (PCS). 4 items, Scale 1-7. Scoring: average (1-7) Higher score indicates greater confidence.
Measured: 12 months
Body Mass Index
Measure of weight at 6months due to low number of 12month in person visits permitting data collection as a result of coronavirus disease 2019 (COVID-19) restrictions
Measured: 6 months
Patient Health Questionnaire-8
Measure of depressive symptoms, Patient Health Questionnaire depression scale (PHQ8). 8 items, Scale 0-3, Scoring average of responses 0-24. Higher score indicates greater depressive symptoms.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start21 Dec 2018
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
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 (4)Papers the sponsor has linked to this study.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- VA Home Telehealth (HT) nurses will deliver the 5 intervention components during telephone encounters. The standard encounter frequency will be every two weeks, but may be extended to every 4 weeks for participants achieving their HbA1c goal. Should Veterans relapse while receiving the lower encounter frequency, HT will return to every-two-week encounters until the next HbA1c assessment. The 5 intervention components are: Telemonitoring, Self-management support, Diet/activity support, Medication management, \& Depression support
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew Crowley, MD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520413
- Sponsor's protocol ID
- IIR 16-213
- Acronym
- PRACTICE-DM
- Status last verified
- Jul 2023
- First submitted
- 27 Apr 2018
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kobe EA, Edelman D, Tarkington PE, Bosworth HB, Maciejewski ML, Steinhauser K, Jeffreys AS, Coffman CJ, Smith VA, Strawbridge EM, Szabo ST, Desai S, Garrett MP, Wilmot TC, Marcano TJ, Overby DL, Tisdale GA, Durkee M, Bullard S, Dar MS, Mundy AC, Hiner J, Fredrickson SK, Majette Elliott NT, Howard T, Jeter DH, Danus S, Crowley MJ. Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial. Contemp Clin Trials. 2020 Nov;98:106157. doi: 10.1016/j.cct.2020.106157. Epub 2020 Sep 21.
PubMed 32971277Lewinski AA, Crowley MJ, Miller C, Bosworth HB, Jackson GL, Steinhauser K, White-Clark C, McCant F, Zullig LL. Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake. Med Care. 2021 Jun 1;59(Suppl 3):S242-S251. doi: 10.1097/MLR.0000000000001553.
PubMed 33976073Crowley MJ, Tarkington PE, Bosworth HB, Jeffreys AS, Coffman CJ, Maciejewski ML, Steinhauser K, Smith VA, Dar MS, Fredrickson SK, Mundy AC, Strawbridge EM, Marcano TJ, Overby DL, Majette Elliott NT, Danus S, Edelman D. Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial. JAMA Intern Med. 2022 Sep 1;182(9):943-952. doi: 10.1001/jamainternmed.2022.2947.
PubMed 35877092Duffy RA, Jeffreys AS, Coffman CJ, Alexopoulos AS, Tarkington PE, Bosworth H, Edelman D, Crowley MJ. Evaluating Therapeutic Inertia in Two Telehealth Interventions for Type 2 Diabetes: Secondary Analyses of a Randomized Trial. Telemed J E Health. 2024 Jun;30(6):e1790-e1797. doi: 10.1089/tmj.2023.0453. Epub 2024 Feb 19.
PubMed 38377570
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Telemedicine to Improve Control and Engagement for Veterans With Clinic-Refractory Diabetes Mellitus (PRACTICE-DM)
- ClinicalTrials.gov ID
- NCT03520413
- Acronym / sponsor ID
- PRACTICE-DM / IIR 16-213
- Conditions
- Telemedicine
- Keywords
- Complex Care, Outcomes, Telemedicine, Rural Health, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Dec 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Posted 26 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetes generates significant morbidity, mortality, and costs within the Veterans Health Administration (VHA). Veterans with persistently poor diabetes control despite clinic-based care are among the highest-risk diabetes patients in VHA, and contribute disproportionately to VHA's massive burden of diabetes complications and costs. VHA critically needs effective, practical management alternatives for Veterans whose diabetes does not respond to clinic-based management. The proposed study will address this need by leveraging VHA's unique Home Telehealth capacity to deliver comprehensive telemedicine-based management for Veterans with persistently poor diabetes control despite clinic-based care. Because this intensive intervention is delivered using only existing Home Telehealth workforce, infrastructure, and technical resources - which are ubiquitous at VHA centers nationwide - it could represent an effective, practical approach to improving outcomes in Veterans with PPDM, potentially translating to a substantial reduction in VHA's diabetes burden.
Detailed description
This study will evaluate a comprehensive telemedicine intervention for Veterans with persistently poor diabetes control despite clinic-based Veterans Health Administration (VHA) care. Because this approach is designed for delivery via existing Home Telehealth (HT) services, which are ubiquitous throughout VHA, it may represent an effective, practical alternative for Veterans whose diabetes is refractory to clinic-based care.
Although efforts by clinicians and researchers have improved diabetes control across VHA, Veterans with persistent poorly-controlled diabetes mellitus (PPDM) have not benefitted from these advances. The investigators define PPDM as maintenance of a hemoglobin A1c (HbA1c) 8.5% for >1 year, despite receiving clinic-based diabetes care during this period. Veterans meeting this definition - approximately 12% of all Veterans with type 2 diabetes - contribute disproportionately to VHA's burden of diabetes complications and costs.
While clinic-based care is insufficiently effective in PPDM, telemedicine-based management that comprehensively addresses factors underlying poor diabetes control could improve outcomes for these high-risk Veterans. Unfortunately, healthcare systems have rarely integrated comprehensive telemedicine-based care into real-world practice, even for clinic-refractory conditions like PPDM. This gap stems from the fact that comprehensive telemedicine-based diabetes care has not previously been designed for practical delivery under real-world conditions. In order for telemedicine to fulfill its potential as a means to reduce the burden of PPDM, interventions must be developed with an emphasis on feasible delivery through existing workforce, infrastructure, and technical resources, such that effective implementation is eventually achievable. Until then, Veterans with PPDM will be left without alternatives when clinic-based care proves inadequate.
The proposed trial will evaluate Practical Telemedicine to Improve Control and Engagement for Veterans with Clinic-Refractory Diabetes Mellitus (PRACTICE-DM), a novel, comprehensive telemedicine intervention for PPDM that is designed for practical delivery within VHA. The Specific Aims of this study are to: 1) determine PRACTICE-DM's effectiveness; 2) evaluate PRACTICE-DM's acceptability and mechanisms of effect using a mixed method process evaluation; and 3) understand costs associated with PRACTICE-DM.
Two hundred Veterans with PPDM from two sites (Durham, North Carolina (NC) and Richmond, Virginia (VA)) will be randomized to receive one of two HT-delivered interventions: 1) PRACTICE-DM, a comprehensive intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression support; or 2) an active control, standard HT care coordination and telemonitoring. Both interventions will be delivered over a 12-month period and all participants will continue to receive usual VHA care.
The primary study outcome will be change in HbA1c from study baseline to 12 months. The secondary outcomes are guided by a theoretical framework, and will include diabetes self-care, diabetes burden, self-efficacy, and depressive symptoms. Qualitative interviews will be conducted with 20 intervention-group Veterans, the HT nurses delivering the intervention, and administrators at each site. Intervention costs will be comprehensively assessed and compared to standard HT care coordination and telemonitoring.
Although VHA is a leader in telemedicine, its telemedicine capabilities are currently underutilized for Veterans with PPDM. These Veterans are refractory to clinic-based care, so contribute disproportionately to diabetes complications and costs. This study will leverage VHA's unique telemedicine infrastructure to deliver comprehensive management designed for PPDM, with the goal of improving outcomes in this high-risk, high cost population. Because the proposed intervention is designed for delivery using existing HT services, it may represent an effective, practical approach to reducing the burden of poor diabetes control across VHA.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- VA Home Telehealth (HT) nurses will deliver the 5 intervention components during telephone encounters. The standard encounter frequency will be every two weeks, but may be extended to every 4 weeks for participants achieving their HbA1c goal. Should Veterans relapse while receiving the lower encounter frequency, HT will return to every-two-week encounters until the next HbA1c assessment. The 5 intervention components are: Telemonitoring, Self-management support, Diet/activity support, Medication management, \& Depression support
| Arm | Type | Receives |
|---|---|---|
| PRACTICE-DM | Experimental | Other: PRACTICE-DMPRACTICE-DM is a comprehensive telemedicine intervention that bundles telemonitoring, self-management support, diet/activity support, medication management, and depression support - each of which targets a critical factor underlying PPDM - into a single, comprehensive program specifically developed for practical delivery using existing VHA Home Telehealth (HT) workforce, infrastructure, and technical resources. |
| Standard VA Home Telehealth | Active comparator | Other: Standard VA Home TelehealthStandard VA HT care coordination and telemonitoring. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Veterans with persistently poorly-controlled type 2 diabetes mellitus defined as the presence of 2 HbA1c values 8.5% during the prior year (none <8.5%) despite 1 or more appointments with a VHA Primary Care Provider (PCP) or Endocrinology during this period.
Key exclusion criteria (14 listed)
- age >70
- life expectancy <5 years, or other comorbidities that would offset the benefits of HbA1c <8.5%
- inability to communicate by telephone
- dementia or psychosis
- active alcohol/substance disorder
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 |
|---|---|---|
| PRACTICE-DMFive-component diabetes intervention: 1) telemonitoring; 2) self-management support; 3) diet/activity support; 4) medication management; and 5) depression support. | Other | PRACTICE-DM |
| Standard VA Home TelehealthStandard VA HT care coordination and telemonitoring. | Other | Standard VA Home Telehealth |
Primary outcome
Hemoglobin A1c
Time frame: 12 months
Laboratory blood test to measure diabetes control
5 secondary outcomes
Diabetes Distress Scale
Time frame: 12 months
Diabetes Self-Management Questionnaire
Time frame: 12 months
Perceived Competence Scale
Time frame: 12 months
Body Mass Index
Time frame: 6 months
Patient Health Questionnaire-8
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32971277Kobe EA, Edelman D, Tarkington PE, Bosworth HB, Maciejewski ML, Steinhauser K, Jeffreys AS, Coffman CJ, Smith VA, Strawbridge EM, Szabo ST, Desai S, Garrett MP, Wilmot TC, Marcano TJ, Overby DL, Tisdale GA, Durkee M, Bullard S, Dar MS, Mundy AC, Hiner J, Fredrickson SK, Majette Elliott NT, Howard T, Jeter DH, Danus S, Crowley MJ. Practical telehealth to improve control and engagement for patients with clinic-refractory diabetes mellitus (PRACTICE-DM): Protocol and baseline data for a randomized trial. Contemp Clin Trials. 2020 Nov;98:106157. doi: 10.1016/j.cct.2020.106157. Epub 2020 Sep 21.
- Results publication: PubMed 33976073Lewinski AA, Crowley MJ, Miller C, Bosworth HB, Jackson GL, Steinhauser K, White-Clark C, McCant F, Zullig LL. Applied Rapid Qualitative Analysis to Develop a Contextually Appropriate Intervention and Increase the Likelihood of Uptake. Med Care. 2021 Jun 1;59(Suppl 3):S242-S251. doi: 10.1097/MLR.0000000000001553.
- Results publication: PubMed 35877092Crowley MJ, Tarkington PE, Bosworth HB, Jeffreys AS, Coffman CJ, Maciejewski ML, Steinhauser K, Smith VA, Dar MS, Fredrickson SK, Mundy AC, Strawbridge EM, Marcano TJ, Overby DL, Majette Elliott NT, Danus S, Edelman D. Effect of a Comprehensive Telehealth Intervention vs Telemonitoring and Care Coordination in Patients With Persistently Poor Type 2 Diabetes Control: A Randomized Clinical Trial. JAMA Intern Med. 2022 Sep 1;182(9):943-952. doi: 10.1001/jamainternmed.2022.2947.
- Derived from this study: PubMed 38377570Duffy RA, Jeffreys AS, Coffman CJ, Alexopoulos AS, Tarkington PE, Bosworth H, Edelman D, Crowley MJ. Evaluating Therapeutic Inertia in Two Telehealth Interventions for Type 2 Diabetes: Secondary Analyses of a Randomized Trial. Telemed J E Health. 2024 Jun;30(6):e1790-e1797. doi: 10.1089/tmj.2023.0453. Epub 2024 Feb 19.
- 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.
Matthew Crowley, MD principal investigator
Durham VA Medical Center, Durham, NC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRACTICE-DM and Standard VA Home Telehealth in people with Telemedicine, run by VA Office of Research and Development 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 1 inclusion and 14 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 27 Jul 2023. 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?
Yes. Results are posted in the registry (first posted 26 Jan 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?
Hemoglobin A1c (time frame: 12 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 NCT03520413, which also lists 4 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 27 Jul 2023.