Diabetes MellitusNCT02681185
Efficacy of a Virtual Care Clinic in the Management of Diabetes Mellitus
A study testing Virtual Care in people with Diabetes Mellitus, run by Endocrine Research Society at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Virtual Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2018to 4 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Virtual Care, Standard of Care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual CareOther
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.
Standard of CareOther
Standard of care offered in the patient's community. May involve in-person education at a diabetes centre and consultation with a healthcare professional.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Group | Experimental | The recruited participants will be provided access to Virtual Care suite via internet and telephone communication. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month intervals for 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Start and End of study (six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study start1 Mar 2018
- Primary completion4 Jul 2023
- Study completion4 Jul 2023
Why it stopped: enrollment not satisfied
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental vs. Standard of Care
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endocrine Research Society
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERS Gap Student, Endocrine Research Society
- Investigators
- Adam White, MD, Principal investigator, Clinical Associate Professor, UBCMonika Pawlowska, MD, Principal investigator, Clinical Assistant Professor, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681185
- Sponsor's protocol ID
- Virtual Care
- Status last verified
- Sep 2023
- First submitted
- 19 Jan 2016
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 16371630Intensive 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.
PubMed 9742976Hirsch 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.
PubMed 18937550Austin 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.
PubMed 17102152Tildesley 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.
PubMed 20668152Tildesley 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.
PubMed 24500556Tildesley 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.
PubMed 24459161Tildesley 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.
PubMed 25456641
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Virtual Care Clinic in the Management of Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02681185
- Acronym / sponsor ID
- Virtual Care
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment not satisfied
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Endocrine Research SocietyUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 4 Jul 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental vs. Standard of Care
| Arm | Type | Receives |
|---|---|---|
| Interventional Group | Experimental | Other: Virtual CareThe recruited participants will be provided access to Virtual Care suite via internet and telephone communication. |
| Standard of Care | Active comparator | Other: Standard of CareThe recruited participants will receive the standard of diabetes care as offered by the services in their community. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual CareVirtual 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. | Other | Interventional Group |
| Standard of CareStandard of care offered in the patient's community. May involve in-person education at a diabetes centre and consultation with a healthcare professional. | Other | Standard of Care |
Primary outcome
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.
2 secondary outcomes
Survey of Healthcare Utilization
Time frame: Start and End of study (six months)
Survey of Quality of Life
Time frame: Start and End of study (six months)
Results and safety
The study was stopped early (reason given: enrollment not satisfied). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 16371630Nathan 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.
- Background: PubMed 9742976Intensive 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.
- Background: PubMed 18937550Hirsch 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.
- Background: PubMed 17102152Austin 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.
- Background: PubMed 20668152Tildesley 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.
- Background: PubMed 24500556Tildesley 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.
- Background: PubMed 24459161Tildesley 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.
- Background: PubMed 25456641Tildesley 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam White, MD principal investigator
Clinical Associate Professor, UBC
Monika Pawlowska, MD principal investigator
Clinical Assistant Professor, UBC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Care in people with Diabetes Mellitus, run by Endocrine Research Society at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: enrollment not satisfied). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 3 month intervals for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681185, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.