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

NCT02681185 | Terminated

• 1 other identifier: Virtual Care
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Survey of Healthcare Utilization

  Start and End of study (six months)

• Survey of Quality of Life

  Start and End of study (six months)

Study Arms (2)

Interventional Group

EXPERIMENTAL

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

Other: Virtual Care

Standard of Care

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

Virtual Care OTHER

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.

Interventional Group

Standard of Care OTHER

Standard of care offered in the patient's community. May involve in-person education at a diabetes centre and consultation with a healthcare professional.

Standard of Care

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endocrine Research Society: lead

Study Sites (1)

Endocrine Research Society

Vancouver, British Columbia, V6J4Y3, Canada

Location

Related Publications (8)

• 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.

  PMID: 16371630 BACKGROUND

• 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.

  PMID: 9742976 BACKGROUND

• 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.

  PMID: 18937550 BACKGROUND

• 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.

  PMID: 17102152 BACKGROUND

• 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.

  PMID: 20668152 BACKGROUND

• 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.

  PMID: 24500556 BACKGROUND

• 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.

  PMID: 24459161 BACKGROUND

• 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.

  PMID: 25456641 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Telemedicine; Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Quality Indicators, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Adam White, MD

  Clinical Associate Professor, UBC

  PRINCIPAL INVESTIGATOR

• Monika Pawlowska, MD

  Clinical Assistant Professor, UBC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Experimental vs. Standard of Care

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 12, 2016
• Study Start: March 1, 2018
• Primary Completion: July 4, 2023
• Study Completion: July 4, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)