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

  Show Detailed Description

  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
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014