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

Endocrine Research Society

Status: Terminated

Conditions: Diabetes Mellitus

Treatments: Other: Virtual Care; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT02681185

Virtual Care

Details and patient eligibility

About

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.

Full description

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

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.

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. 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.

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.

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.

Enrollment: 11 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Interventional Group

Experimental group

Description:

The recruited participants will be provided access to Virtual Care suite via internet and telephone communication.

Treatment:

Other: Virtual Care

Standard of Care

Active Comparator group

Description:

The recruited participants will receive the standard of diabetes care as offered by the services in their community.

Treatment:

Other: Standard of Care