NCT03960424

Brief Summary

To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 30, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 12, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2023

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

3.4 years

First QC Date

May 9, 2019

Last Update Submit

October 13, 2023

Conditions

Type 2 Diabetes MellitusType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1C

    HbA1c

    6 months

Secondary Outcomes (9)

  • HbA1c

    12 months

  • Hypoglycemia episodes

    6 months

  • Adherence

    6 months

  • Diabetes self-efficacy

    6 months

  • PAID

    6 months

  • +4 more secondary outcomes

Study Arms (2)

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.

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.

Other: Comprehensive Outpatient Management

Interventions

Comprehensive Outpatient ManagementOTHER

Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting.

Also known as: COM
Comprehensive Outpatient Management (COM)
Diabetes TelemonitoringBEHAVIORAL

Diabetes Telehealth Management (DTM), based on the 2018 ADA Standards for T2D, uses smart devices to share information between patients, caregivers, and clinicians.

Also known as: DTM
Diabetes Telemonitoring (DTM)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hispanic patients with a diagnosis of diabetes
  • Speaks English or Spanish

You may not qualify if:

  • Patient is not Hispanic
  • Patient does not have a diagnosis of diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Feinstein Institute of Medical Research

Manhasset, New York, 11030, United States

Location

Related Publications (1)

  • 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.

    PMID: 33287815DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Renee Pekmezaris, PhD

    Feinstein Institute for Medical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Mixed Methods Design, incorporating adaptations before RCT trial commencement.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 23, 2019

Study Start

September 30, 2019

Primary Completion

March 12, 2023

Study Completion

September 8, 2023

Last Updated

October 16, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)