Efficacy of a Virtual Care Clinic in the Management of Diabetes Mellitus

September 18, 2023 updated by: ERS Gap Student, Endocrine Research Society
The study's goal is to promote accessible and cost-effective diabetes care through electronic means. Underserved populations including rural areas do not have diabetes specialists. Previous study data has shown the effectiveness of Internet communication in lowering a patient's Hemoglobin A1C, a measure of blood sugars, closer to the target number. The investigators thus wish to test the effectiveness of diabetes care provided by virtual means, including virtual consultations, online monitoring of blood sugars, diabetes education via web-based videos, and support/advice provided through phone or email by an Endocrinologist. The goal is to test if virtual care is a viable means to extend care for diabetes to underserved populations.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

  1. Purpose To determine if a virtual-care based system can effectively provide care for patients with diabetes.

  2. Hypothesis Alternative: Virtual-care is associated with achieving glycemic control in patients with diabetes.

    Null: Virtual-care is not associated with achieving glycemic control in patients with diabetes.

  3. Justification The potential study participants would normally receive care from a primary care physician and have no access to a diabetes specialist. In the study, they would have access to an Endocrinologist through online communication and by telephone.
  4. Objectives The primary end-point is to determine if patients using virtual care have reduced HbA1c values at followup. The data may be used to write a white paper guiding diabetes treatment guidelines within the province of British Columbia, Canada. The goal is for diabetes specialists to be able to provide care to underserved areas without requiring to be physically at the location.

  5. Research Method Participants satisfying the inclusion criteria will be recruited and followed for six months. Their family physician or Diabetes Center will provide a referral to one of the investigators, who are diabetes specialists, for a virtual consult via telephone. Relevant medical records will be transferred for this consult.

    After the consult, participants will be asked to submit self-monitored blood glucose levels via email to the diabetes specialists for follow-up every two weeks. These follow-up reports may lead to the diabetes specialists making adjustments to therapy.

    Concurrently, the participants during the followup period will be provided access to a free website containing modules on diabetes education similar to a diabetes clinic education program. They will be allowed to view them at their own discretion..

    Every 3 months participants will be asked to have regular blood work done to assess management, including A1C levels. This is part of routine care, but the data will be used for analysis.

  6. Statistical Analysis Outcomes will be tested for significant differences via t tests, as well as the other clinical measures, while the summarized survey responses will be tallied and tested for correlation with changes in clinical measures.

The planned sample size of 100 was estimated from previous studies' mean changes in A1C and standard deviations involving similar methods. For calculating the sample size, a statistical power of 0.80 and alpha of 0.05 were used.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6J4Y3
        • Endocrine Research Society

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Type 2 Diabetes
  • Access and the ability to use the internet on a computer or mobile device
  • Access to a family physician and lab for blood tests

Exclusion Criteria:

  • Patients that are pregnant or attempting to conceive
  • Liver disease (AST or ALT levels >2.5 times the reference level)
  • Renal insufficient with a serum creatine level >200 umol/L
  • Patients who see an endocrinologist or diabetes specialist within their community

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Group
The recruited participants will be provided access to Virtual Care suite via internet and telephone communication.
Other: Virtual Care

Virtual Care consists of the following services and resources:

  1. Have a virtual consult through online methods or telephone with one of the study endocrinologists
  2. Be encouraged to report blood sugar readings every 2 weeks to their endocrinologist for regular follow-up and feedback via online methods
  3. Be given access to a website with modules that attempt to replicate the information learned in a diabetes teaching clinic
  4. Be given access to a certified diabetes educator through online methods or telephone. This will cover any other information that cannot be personalized on the teaching website, such as specific diet advice and social support.
Active Comparator: Standard of Care
The recruited participants will receive the standard of diabetes care as offered by the services in their community.
Other: Standard of Care
Standard of care offered in the patient's community. May involve in-person education at a diabetes centre and consultation with a healthcare professional.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 3 month intervals for 6 months
Routine blood work measuring average blood sugar levels, at total of two tests will be preformed at three month intervals over the 6 month study period. Baseline A1C at recruitment will also be included in analysis.
3 month intervals for 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survey of Healthcare Utilization
Time Frame: Start and End of study (six months)
At the start and end of study (six months), participants will complete a self-reported survey of their utilization of healthcare services, including hospitalizations, physician visits, intervention website visits, perceived medication changes.
Start and End of study (six months)
Survey of Quality of Life
Time Frame: Start and End of study (six months)
At the start and end of study (six months), participants will complete the Audit for Diabetes Dependent Quality of Life survey.
Start and End of study (six months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Endocrine Research Society

Investigators

  • Principal Investigator: Adam White, MD, Clinical Associate Professor, UBC
  • Principal Investigator: Monika Pawlowska, MD, Clinical Assistant Professor, UBC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

July 4, 2023

Study Completion (Actual)

July 4, 2023

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimated)

February 12, 2016

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 18, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Virtual Care

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data collected during the study will be stored on study site in an encrypted format, all data pertaining to individual patients will be available only to the study investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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