Internet Monitoring vs Medication to Control Blood Sugar in Type 2 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Endocrine Research Society
Sponsor:
Information provided by (Responsible Party):
Dr. Hugh Tildesley, Endocrine Research Society
ClinicalTrials.gov Identifier:
NCT02185755
First received: July 7, 2014
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Other: Internet-Based Glucose Monitoring System
Drug: Normal Medication Positive Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Investigating if an Internet-Based Glucose Monitoring System is as Effective as Medication at Reducing HbA1c Levels in Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Endocrine Research Society:

Primary Outcome Measures:
  • HbA1c Levels before and after intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compare HbA1c Levels before and after intervention for both arms, as well as the difference in HbA1c Levels between arms.


Secondary Outcome Measures:
  • The secondary endpoint include severe hypoglycemia defined as requiring external aid (hospital or other). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • HbA1c levels remain at 8% or higher [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: August 2014
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Internet-Based Glucose Monitoring System
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.
Other: Internet-Based Glucose Monitoring System
Other Names:
  • Internet Blood Glucose Monitoring System
  • Remote Blood Glucose Monitoring System
Normal Medication Positive Control
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.
Drug: Normal Medication Positive Control

Detailed Description:
  1. Purpose:

    To determine the effectiveness of an Internet-based glucose monitoring system (IBGMS) in the absence of medication changes.

  2. Hypothesis:

    IBGMS without medication changes is comparable to conventional medication at reducing HbA1c levels over 8% in patients with T2DM.

  3. 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.

  4. 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.
  5. 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.

  6. 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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02185755

Contacts
Contact: Nelson Chow, BSc 604 602-1011 nchow.ers@shaw.ca

Locations
Canada, British Columbia
Dr. Hugh Tildesley Inc. Recruiting
Vancouver, British Columbia, Canada, V6E1M7
Contact: Nelson Chow, BSc    604 602 1011    nchow.ers@shaw.ca   
Principal Investigator: Hugh D Tildesley, MD, FRCP(C)         
Sponsors and Collaborators
Endocrine Research Society
Investigators
Principal Investigator: Hugh D Tildesley, MD Providence Health Care, University of British Columbia
  More Information

Publications:

Responsible Party: Dr. Hugh Tildesley, Medical Director, Endocrine Research Society
ClinicalTrials.gov Identifier: NCT02185755     History of Changes
Other Study ID Numbers: IBGMS standalone
Study First Received: July 7, 2014
Last Updated: September 8, 2014
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Endocrine Research Society:
Internet-Based Glucose Monitoring System
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014