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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Virtual Care
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental vs. Standard of Care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Group<br>The recruited participants will be provided access to Virtual Care suite via internet and telephone communication. | Other: Virtual Care<br>* Virtual Care consists of the following services and resources: Have a virtual consult through online methods or telephone with one of the study endocrinologists Be encouraged to report blood sugar readings every 2 weeks to their endocrinologist for regular follow-up and feedback via online methods Be given access to a website with modules that attempt to replicate the information learned in a diabetes teaching clinic 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.<br>|
| Active Comparator: Standard of Care<br>The recruited participants will receive the standard of diabetes care as offered by the services in their community. | Other: Standard of Care<br>* Standard of care offered in the patient's community. May involve in-person education at a diabetes centre and consultation with a healthcare professional.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | 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 | 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 | 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) |