Type 2 Diabetes MellitusNCT02185755
Internet Monitoring vs Medication to Control Blood Sugar in Type 2 Diabetes
A study testing Internet-Based Glucose Monitoring System in people with Type 2 Diabetes Mellitus, run by Endocrine Research Society at 1 site in Canada.
Trial summary
Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to minimize health problems and complications. One way for patients to notify doctors and receive feedback about their blood sugar management is through an online system. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Internet-Based Glucose Monitoring System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Aug 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients being treated with oral hypoglycemic agents
- HbA1c > 8%
- Willingness to test blood glucose levels a minimum of 3 times daily
- Willingness to be trained on using the Internet-Based Glucose Monitoring System
- Willingness to be randomized
- Trained in self-blood glucose monitoring
- Internet access on a computer
- No prior use or training on IBGMS
Who cannot join
- Patient with medical conditions that may affect their study participation or results will be excluded.
- Patients using medications known to influence control of diabetes (eg steroids systemic or inhaled)
- Liver disease (AST (aspartate aminotransferase) or ALT (alanine aminotransferase) levels > 2.5 times the reference level)
- Renal insufficient with a serum creatinine level > 200 μmol/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating if an Internet-Based Glucose Monitoring System is as Effective as Medication at Reducing HbA1c Levels in Type 2 Diabetes Mellitus
Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to minimize health problems and complications. One way for patients to notify doctors and receive feedback about their blood sugar management is through an online system. As Internet-based glucose monitoring systems (IBGMS) have already been shown to be effective, the investigators hypothesize that IBGMS is effective as an intervention even when limiting feedback to non-medicine related changes.
Read the detailed description
- Purpose: To determine the effectiveness of an Internet-based glucose monitoring system (IBGMS) in the absence of medication changes.
- Hypothesis: IBGMS without medication changes is comparable to conventional medication at reducing HbA1c levels over 8% in patients with T2DM.
- Justification: Patients with T2DM having elevated HbA1c levels may be prescribed additional medications to help manage their blood sugar levels, which include oral hypoglycemic agents and/or insulin. As IBGMS has been shown to be effective in reducing HbA1c in T2DM, there is an opportunity to determine whether if this system could be used as an alternative to medication. The benefits would include reduced side effects as a result of substituting for the effects of medication, as well as reduced financial costs associated with acquiring medication. Considering that IBGMS increases the frequency at which patients receive feedback to change medications as compared to typical treatment, the risk is as typical for a patient opting for no medication changes for the same period of time.
- Objectives: The primary end-point is to determine if patients using IBGMS have reduced HbA1c values at followup, and to compare the reduction to the control group on typical medications.
- Research Method: 120 patients with T2DM satisfying the inclusion criteria will be recruited and have baseline HbA1c established through regular lab blood tests. They will be randomized into one of two groups, one that will be trained to use IBGMS and one control group going on an appropriate additional medication. The IBGMS group will be asked to report their blood sugars to their endocrinologist biweekly and receive feedback for each report. No medication changes will be offered in the feedback, but lifestyle or dietary recommendations may be included. The control group will be asked to take their new medications as indicated by their endocrinologist. Both groups will have followup visits with their endocrinologist at 3 and 6 months, and will also have blood tests done at those time points checking their HbA1c levels. The effectiveness of both interventions will be evaluated individually and against each other. For the IBGMS group, a rescue secondary endpoint occurs if a subject maintains an HbA1c level at or greater than 8% after 3 months; the subject will be withdrawn from the study and put under standard care.
- Statistical Analysis: The sample size was calculated to be 120 by estimating mean differences and standard deviations using data from previous studies. For the calculation the statistical power was 0.80 and alpha of 0.05.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Internet-Based Glucose Monitoring System, Normal Medication Positive Control
- Keywords
- Internet-Based Glucose Monitoring System, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-Based Glucose Monitoring SystemOther
Also called Internet Blood Glucose Monitoring System, Remote Blood Glucose Monitoring System
Normal Medication Positive ControlDrug
| Study group | Role | What they receive |
|---|---|---|
| Internet-Based Glucose Monitoring System | Active comparator | The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and provide feedback limited to non-medicine related comments and suggestions. Receives: Other: Internet-Based Glucose Monitoring System |
| Normal Medication Positive Control | Other | The subjects will be prescribed a new medication as appropriate for normal therapy. This group will receive no biweekly feedback nor require to report online, but will see the endocrinologist every 3 months up to 6 months. Receives: Drug: Normal Medication Positive Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Levels before and after intervention
Compare HbA1c Levels before and after intervention for both arms, as well as the difference in HbA1c Levels between arms.
Measured: 6 months
Secondary outcomes (3)
The secondary endpoint include severe hypoglycemia defined as requiring external aid (hospital or other).
Measured: 6 months
A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours
Measured: 6 months
HbA1c levels remain at 8% or higher
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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
- Hugh D Tildesley, MD, Principal investigator, Providence Health Care, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185755
- Sponsor's protocol ID
- IBGMS standalone
- Status last verified
- Sep 2023
- First submitted
- 7 Jul 2014
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
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 20668152Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD, Yoo SJ, Song KH, Son HS, Kim HS, Lee WC, Cha BY, Son HY, Yoon KH. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006 Dec;29(12):2625-31. doi: 10.2337/dc05-2371.
PubMed 17130195
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
- Investigating if an Internet-Based Glucose Monitoring System is as Effective as Medication at Reducing HbA1c Levels in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02185755
- Acronym / sponsor ID
- IBGMS standalone
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Internet-Based Glucose Monitoring System, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Endocrine Research SocietyUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 10 Jul 2014 (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.
Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to minimize health problems and complications. One way for patients to notify doctors and receive feedback about their blood sugar management is through an online system. As Internet-based glucose monitoring systems (IBGMS) have already been shown to be effective, the investigators hypothesize that IBGMS is effective as an intervention even when limiting feedback to non-medicine related changes.
Detailed description
- Purpose: To determine the effectiveness of an Internet-based glucose monitoring system (IBGMS) in the absence of medication changes.
- Hypothesis: IBGMS without medication changes is comparable to conventional medication at reducing HbA1c levels over 8% in patients with T2DM.
- Justification: Patients with T2DM having elevated HbA1c levels may be prescribed additional medications to help manage their blood sugar levels, which include oral hypoglycemic agents and/or insulin. As IBGMS has been shown to be effective in reducing HbA1c in T2DM, there is an opportunity to determine whether if this system could be used as an alternative to medication. The benefits would include reduced side effects as a result of substituting for the effects of medication, as well as reduced financial costs associated with acquiring medication. Considering that IBGMS increases the frequency at which patients receive feedback to change medications as compared to typical treatment, the risk is as typical for a patient opting for no medication changes for the same period of time.
- Objectives: The primary end-point is to determine if patients using IBGMS have reduced HbA1c values at followup, and to compare the reduction to the control group on typical medications.
- Research Method: 120 patients with T2DM satisfying the inclusion criteria will be recruited and have baseline HbA1c established through regular lab blood tests. They will be randomized into one of two groups, one that will be trained to use IBGMS and one control group going on an appropriate additional medication. The IBGMS group will be asked to report their blood sugars to their endocrinologist biweekly and receive feedback for each report. No medication changes will be offered in the feedback, but lifestyle or dietary recommendations may be included. The control group will be asked to take their new medications as indicated by their endocrinologist. Both groups will have followup visits with their endocrinologist at 3 and 6 months, and will also have blood tests done at those time points checking their HbA1c levels. The effectiveness of both interventions will be evaluated individually and against each other. For the IBGMS group, a rescue secondary endpoint occurs if a subject maintains an HbA1c level at or greater than 8% after 3 months; the subject will be withdrawn from the study and put under standard care.
- Statistical Analysis: The sample size was calculated to be 120 by estimating mean differences and standard deviations using data from previous studies. For the calculation the statistical power was 0.80 and alpha of 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-Based Glucose Monitoring System | Active comparator | Other: Internet-Based Glucose Monitoring SystemThe subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and provide feedback limited to non-medicine related comments and suggestions. |
| Normal Medication Positive Control | Other | Drug: Normal Medication Positive ControlThe subjects will be prescribed a new medication as appropriate for normal therapy. This group will receive no biweekly feedback nor require to report online, but will see the endocrinologist every 3 months up to 6 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetes patients being treated with oral hypoglycemic agents
- HbA1c > 8%
- Willingness to test blood glucose levels a minimum of 3 times daily
- Willingness to be trained on using the Internet-Based Glucose Monitoring System
- Willingness to be randomized
Key exclusion criteria (4 listed)
- Patient with medical conditions that may affect their study participation or results will be excluded.
- Patients using medications known to influence control of diabetes (eg steroids systemic or inhaled)
- Liver disease (AST (aspartate aminotransferase) or ALT (alanine aminotransferase) levels > 2.5 times the reference level)
- Renal insufficient with a serum creatinine level > 200 μmol/L
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 |
|---|---|---|
| Internet-Based Glucose Monitoring SystemAlso: Internet Blood Glucose Monitoring System, Remote Blood Glucose Monitoring System | Other | Internet-Based Glucose Monitoring System |
| Normal Medication Positive Control | Drug | Normal Medication Positive Control |
Primary outcome
HbA1c Levels before and after intervention
Time frame: 6 months
Compare HbA1c Levels before and after intervention for both arms, as well as the difference in HbA1c Levels between arms.
3 secondary outcomes
The secondary endpoint include severe hypoglycemia defined as requiring external aid (hospital or other).
Time frame: 6 months
A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours
Time frame: 6 months
HbA1c levels remain at 8% or higher
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 17130195Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD, Yoo SJ, Song KH, Son HS, Kim HS, Lee WC, Cha BY, Son HY, Yoon KH. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006 Dec;29(12):2625-31. doi: 10.2337/dc05-2371.
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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.
Hugh D Tildesley, MD principal investigator
Providence Health Care, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-Based Glucose Monitoring System in people with Type 2 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 8 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: finished, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Levels before and after intervention (time frame: 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 NCT02185755, which also lists 6 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.