Clinical trial NCT02681185: Efficacy of a Virtual Care Clinic in the Management of Diabetes Mellitus
Official title: Efficacy of a Virtual Care Clinic in the Management of Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Endocrine Research Society
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 11
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental vs. Standard of Care
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c
timeFrame: 3 month intervals for 6 months
Secondary outcomes:
measure: Survey of Healthcare Utilization
timeFrame: Start and End of study (six months)
measure: Survey of Quality of Life
timeFrame: Start and End of study (six months)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Endocrine Research Society
state: British Columbia
Study officials:
affiliation: Clinical Associate Professor, UBC
name: Adam White, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Assistant Professor, UBC
name: Monika Pawlowska, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187.
citation: Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53.
citation: Hirsch IB, Bode BW, Childs BP, Close KL, Fisher WA, Gavin JR, Ginsberg BH, Raine CH, Verderese CA. Self-Monitoring of Blood Glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research. Diabetes Technol Ther. 2008 Dec;10(6):419-39. doi: 10.1089/dia.2008.0104.
citation: Austin MM, Haas L, Johnson T, Parkin CG, Parkin CL, Spollett G, Volpone MT. Self-monitoring of blood glucose: benefits and utilization. Diabetes Educ. 2006 Nov-Dec;32(6):835-6, 844-7. doi: 10.1177/0145721706295873. No abstract available.
citation: Tildesley HD, Mazanderani AB, Ross SA. Effect of Internet therapeutic intervention on A1C levels in patients with type 2 diabetes treated with insulin. Diabetes Care. 2010 Aug;33(8):1738-40. doi: 10.2337/dc09-2256.
citation: Tildesley HD, Wright AM, Chan JH, Mazanderani AB, Ross SA, Tildesley HG, Lee AM, Tang TS, White AS. A comparison of internet monitoring with continuous glucose monitoring in insulin-requiring type 2 diabetes mellitus. Can J Diabetes. 2013 Oct;37(5):305-8. doi: 10.1016/j.jcjd.2013.05.006.
citation: Tildesley HD, Conway ME, Ross SA, Lee AM, Chan JH, Mazanderani AB, Tildesley HG, White AS. Review of the effect of internet therapeutic intervention in patients with type 1 and type 2 diabetes. Diabetes Care. 2014 Feb;37(2):e31-2. doi: 10.2337/dc13-1940. No abstract available.
citation: Tildesley HD, Po MD, Ross SA. Internet blood glucose monitoring systems provide lasting glycemic benefit in type 1 and 2 diabetes: a systematic review. Med Clin North Am. 2015 Jan;99(1):17-33. doi: 10.1016/j.mcna.2014.08.019. Epub 2014 Oct 18.