Type 2 Diabetes MellitusNCT03960424
Diabetes Management Program for Hispanic/Latino
A study testing Comprehensive Outpatient Management and Diabetes Telemonitoring in people with Type 2 Diabetes Mellitus and Type 2 Diabetes, run by Northwell Health at 1 site in United States.
Trial summary
To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Type 2 Diabetes
- What is being tested?
- Comprehensive Outpatient Management and Diabetes Telemonitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 8 Sep 2023
- 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
- Hispanic patients with a diagnosis of diabetes
- Speaks English or Spanish
Who cannot join
- Patient is not Hispanic
- Patient does not have a diagnosis of diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institute of Medical Research
Manhasset, New York, 11030
About this study
To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.
Read the detailed description
The investigators propose a multiphase mixed method, Comparative Effectiveness Research Randomized Control Trial (CER RCT) to:
Specific Aim 1: Assess usability of an evidence-based DTM intervention utilizing a Community Based Participatory Research (CBPR) approach and adapt it to facilitate acceptability and feasibility in a population of H/L patients with T2D, and their caregivers and providers.
Specific Aim 2: Assess whether H/L patients receiving DTM attain significantly improved patient-centered outcomes compared to COM, through a CER RCT. Expected outcomes include improved diabetes quality of life (QoL), glucose management (GM), blood pressure (BP), cholesterol, medication adherence, and diabetes self-efficacy (SE), and reduced diabetes distress, problem areas in diabetes (PAID), inpatient utilization, unscheduled T2D physician visits and sick days.
- Conditions
- Type 2 Diabetes Mellitus, Type 2 Diabetes
- Being tested
- Comprehensive Outpatient Management, Diabetes Telemonitoring
- 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.
Comprehensive Outpatient ManagementOther
Also called COM
Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting.
Diabetes TelemonitoringBehavioural
Also called DTM
Diabetes Telehealth Management (DTM), based on the 2018 ADA Standards for T2D, uses smart devices to share information between patients, caregivers, and clinicians.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Telemonitoring (DTM) | Experimental | Diabetes Telehealth Management (DTM), based on the 2018 ADA Standards for Type 2 Diabetes (T2D), uses smart devices to share information between patients, caregivers, and clinicians. DTM includes:1) weekly real time "virtual" visit between patient and clinician 2) vital signs monitoring/interpretation 3) diabetes management 4) patient interactive educational videos and "teach back" quizzes, reinforcing self-management strategies 5) a caregiver app with supportive capability. Receives: Behavioral: Diabetes Telemonitoring |
| Comprehensive Outpatient Management (COM) | Active comparator | Comprehensive Outpatient Management (COM) is the most realistic evidence-based comparator, in that it is the most frequently recommended and used option for US T2D patients. COM, like DTM, is consistent with the 2018 American Diabetes Association (ADA) Standards which include, but are not limited to, past medical and family history, social history, medications, screening, physical examination, laboratory evaluation, etc.Patients are instructed to monitor blood glucose (within physician recommendations), and have routine or "well" visits every 3 months. Patients can set appointments with a T2D educator. COM patients will receive monthly calls from the study Registered Nurse (RN) to collect data. Receives: Other: Comprehensive Outpatient Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
HbA1c
Measured: 6 months
Secondary outcomes (9)
HbA1c
Hemoglobin A1c
Measured: 12 months
Hypoglycemia episodes
Number of hypoglycemia episodes
Measured: 6 months
Adherence
Adherence to Refills and Medications - Diabetes (ARMS-D)
Measured: 6 months
Diabetes self-efficacy
Diabetes Self-Efficacy Scale
Measured: 6 months
PAID
Problem Areas in Diabetes Scale
Measured: 6 months
Weight
lbs
Measured: 6 months
Cholesterol
Changes in cholesterol over time
Measured: 6 months
Blood Pressure
BP
Measured: 6 months
Diabetes Quality of life
Diabetes-39 is a validated instrument specifically designed to measure quality of life for diabetes patients
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 posted23 May 2019
- Study start30 Sep 2019
- Primary completion12 Mar 2023
- Study completion8 Sep 2023
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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Mixed Methods Design, incorporating adaptations before RCT trial commencement.
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Renee Pekmezaris, PhD, Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03960424
- Sponsor's protocol ID
- 19-0002
- Status last verified
- Oct 2023
- First submitted
- 9 May 2019
- Last updated
- 16 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pekmezaris R, Williams MS, Pascarelli B, Finuf KD, Harris YT, Myers AK, Taylor T, Kline M, Patel VH, Murray LM, McFarlane SI, Pappas K, Lesser ML, Makaryus AN, Martinez S, Kozikowski A, Polo J, Guzman J, Zeltser R, Marino J, Pena M, DiClemente RJ, Granville D. Adapting a home telemonitoring intervention for underserved Hispanic/Latino patients with type 2 diabetes: an acceptability and feasibility study. BMC Med Inform Decis Mak. 2020 Dec 7;20(1):324. doi: 10.1186/s12911-020-01346-0.
PubMed 33287815
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Management Program for Hispanic/Latino
- ClinicalTrials.gov ID
- NCT03960424
- Acronym / sponsor ID
- 19-0002
- Conditions
- Type 2 Diabetes Mellitus, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 12 Mar 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 23 May 2019 (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.
To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.
Detailed description
The investigators propose a multiphase mixed method, Comparative Effectiveness Research Randomized Control Trial (CER RCT) to:
Specific Aim 1: Assess usability of an evidence-based DTM intervention utilizing a Community Based Participatory Research (CBPR) approach and adapt it to facilitate acceptability and feasibility in a population of H/L patients with T2D, and their caregivers and providers.
Specific Aim 2: Assess whether H/L patients receiving DTM attain significantly improved patient-centered outcomes compared to COM, through a CER RCT. Expected outcomes include improved diabetes quality of life (QoL), glucose management (GM), blood pressure (BP), cholesterol, medication adherence, and diabetes self-efficacy (SE), and reduced diabetes distress, problem areas in diabetes (PAID), inpatient utilization, unscheduled T2D physician visits and sick days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed Methods Design, incorporating adaptations before RCT trial commencement.
| Arm | Type | Receives |
|---|---|---|
| Diabetes Telemonitoring (DTM) | Experimental | Behavioral: Diabetes TelemonitoringDiabetes Telehealth Management (DTM), based on the 2018 ADA Standards for Type 2 Diabetes (T2D), uses smart devices to share information between patients, caregivers, and clinicians. DTM includes:1) weekly real time "virtual" visit between patient and clinician 2) vital signs monitoring/interpretation 3) diabetes management 4) patient interactive educational videos and "teach back" quizzes, reinforcing self-management strategies 5) a caregiver app with supportive capability. |
| Comprehensive Outpatient Management (COM) | Active comparator | Other: Comprehensive Outpatient ManagementComprehensive Outpatient Management (COM) is the most realistic evidence-based comparator, in that it is the most frequently recommended and used option for US T2D patients. COM, like DTM, is consistent with the 2018 American Diabetes Association (ADA) Standards which include, but are not limited to, past medical and family history, social history, medications, screening, physical examination, laboratory evaluation, etc.Patients are instructed to monitor blood glucose (within physician recommendations), and have routine or "well" visits every 3 months. Patients can set appointments with a T2D educator. COM patients will receive monthly calls from the study Registered Nurse (RN) to collect data. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hispanic patients with a diagnosis of diabetes
- Speaks English or Spanish
Key exclusion criteria (2 listed)
- Patient is not Hispanic
- Patient does not have a diagnosis of diabetes
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 |
|---|---|---|
| Comprehensive Outpatient ManagementAlso: COMPatients receiving comprehensive outpatient management experience typical care received in the outpatient setting. | Other | Comprehensive Outpatient Management (COM) |
| Diabetes TelemonitoringAlso: DTMDiabetes Telehealth Management (DTM), based on the 2018 ADA Standards for T2D, uses smart devices to share information between patients, caregivers, and clinicians. | Behavioural | Diabetes Telemonitoring (DTM) |
Primary outcome
Hemoglobin A1C
Time frame: 6 months
HbA1c
9 secondary outcomes
HbA1c
Time frame: 12 months
Hypoglycemia episodes
Time frame: 6 months
Adherence
Time frame: 6 months
Diabetes self-efficacy
Time frame: 6 months
PAID
Time frame: 6 months
Weight
Time frame: 6 months
Cholesterol
Time frame: 6 months
Blood Pressure
Time frame: 6 months
Diabetes Quality of life
Time frame: 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 16 Oct 2023.
- Derived from this study: PubMed 33287815Pekmezaris R, Williams MS, Pascarelli B, Finuf KD, Harris YT, Myers AK, Taylor T, Kline M, Patel VH, Murray LM, McFarlane SI, Pappas K, Lesser ML, Makaryus AN, Martinez S, Kozikowski A, Polo J, Guzman J, Zeltser R, Marino J, Pena M, DiClemente RJ, Granville D. Adapting a home telemonitoring intervention for underserved Hispanic/Latino patients with type 2 diabetes: an acceptability and feasibility study. BMC Med Inform Decis Mak. 2020 Dec 7;20(1):324. doi: 10.1186/s12911-020-01346-0.
- 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.
Renee Pekmezaris, PhD principal investigator
Feinstein Institute for Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Outpatient Management and Diabetes Telemonitoring in people with Type 2 Diabetes Mellitus and Type 2 Diabetes, run by Northwell Health 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 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. 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?
Hemoglobin A1C (time frame: 6 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 NCT03960424, 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 16 Oct 2023.