NCT05541120

Brief Summary

This is a randomized controlled trial of the use of Remote Patient Monitoring (RPM) compared to usual care among rural patients with poorly controlled type 2 diabetes. Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program and Primary Care Provider evaluation and management at the providers' discretion, including medication adjustment or interventions, and other types of interventions depending on clinical judgement.

Trial Health

50
Monitor

Trial Health Score

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

Timeline
4mo left

Started Oct 2022

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Progress92%
Oct 2022Aug 2026

First Submitted

Initial submission to the registry

August 30, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 18, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

3.7 years

First QC Date

August 30, 2022

Last Update Submit

February 15, 2023

Conditions

Diabetes Mellitus, Type 2

Keywords

remote patient monitoringglycemic control

Outcome Measures

Primary Outcomes (6)

  • Mean HbA1c%

    Average glycated hemoglobin

    6 months after enrollment

  • Mean HbA1c%

    Average glycated hemoglobin

    9 months after enrollment

  • Mean change in HbA1c%

    Average change in percentage of HbA1c from baseline to 6 months after enrollment

    6 months after enrollment

  • Mean change in HbA1c%

    Average change in percentage of HbA1c from baseline to 9 months after enrollment

    9 months after enrollment

  • Percentage of participants in each group who have HbA1c < 7%

    Percentage of participants in each group with HbA1c \< 7%

    6 months after enrollment

  • Percentage of participants in each group who have HbA1c < 7%

    Percentage of participants in each group with HbA1c \< 7%

    9 months after enrollment

Secondary Outcomes (4)

  • PAM-13 at 6 months after enrollment

    6 months after enrollment

  • PAM-13 at 9 months after enrollment

    9 months after enrollment

  • Mean change in PAM-13 at 6 months

    6 months after enrollment

  • Mean change in PAM-13 at 9 months

    9 months after enrollment

Study Arms (2)

Living Well with Diabetes

NO INTERVENTION

Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program, PCP evaluation and management, including medication adjustment or interventions, and other types of interventions depending on clinical judgement. This may include eConsults between the provider and a pharmacist, in-person visits between the provider and the patient, synchronous telemedicine visits between the provider and the patient, and synchronous telemedicine visits between the pharmacist and the patient.

Living Well with Diabetes + Remote Patient Monitoring

EXPERIMENTAL

Remote patient monitoring as the intervention is defined as a tablet and Bluetooth-enabled glucometer technology that collects point-of-care (POC) blood glucose data from a patient outside of a traditional clinical setting, and securely transmits this data to Epic for review and potential intervention.

Device: Remote Patient Monitoring

Interventions

Remote Patient MonitoringDEVICE

Remote patient monitoring as the intervention is defined as a tablet and Bluetooth-enabled glucometer technology that collects point-of-care (POC) blood glucose data from a patient outside of a traditional clinical setting, and securely transmits this data to Epic for review and potential intervention.

Living Well with Diabetes + Remote Patient Monitoring

Eligibility Criteria

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

You may qualify if:

  • Be enrolled in Living Well with Diabetes education program
  • Have an HbA1c% ≥ 8 in the prior 6 months
  • Be capable of providing consent
  • Be adults (age 18 or over)

You may not qualify if:

  • Primarily managed by endocrinology for their diabetes (\> 1 visit with endocrinology in the previous 12 months)
  • Incarcerated
  • PCP not at one of the 30 primary care practices listed (see attachment List of PCP Practices)
  • Diagnosed with type 1 diabetes
  • Candidate for continuous glucose monitoring, as defined by Centers for Medicare and Medicaid Services as using at least three insulin injections per day, any combination of types of insulins
  • Pregnant
  • Have previously participated in the Living Well with Diabetes/Virtual Diabetes Self-Management Program
  • Have previously used a remote patient monitoring device for diabetes management
  • Have a diagnosis of dementia or other clinical diagnosis that would impair participation capacity
  • Currently participating in any other clinical trial regarding diabetes care or management
  • Currently enrolled in hospice
  • Currently residing in a long term care or rehabilitation facility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PenBay Medical Center

Rockport, Maine, 04856, United States

Location

Related Publications (53)

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    PMID: 31856796BACKGROUND

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    PMID: 25716663BACKGROUND

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Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Tracy Jalbuena, MD

    MaineHealth

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled trial of the use of RPM compared to usual care among MaineHealth's rural patients with poorly controlled diabetes, where the participant's diabetes is managed primarily by primary care (as opposed to endocrinology). Usual care is defined as participation in Living Well with Diabetes/Virtual Diabetes Self-Management Program, PCP evaluation and management at the providers' discretion, including medication adjustment or interventions, and other types of interventions depending on clinical judgement. This may include eConsults between the provider and a pharmacist, in-person visits between the provider and the patient, synchronous telemedicine visits between the provider and the patient, and synchronous telemedicine visits between the pharmacist and the patient.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Lead for Telehealth

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 15, 2022

Study Start

October 18, 2022

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)