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

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ClinicalTrials.gov Identifier: NCT02185755
Recruitment Status : Active, not recruiting
First Posted : July 10, 2014
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
ERS Gap Student, Endocrine Research Society

Brief 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. 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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Internet-Based Glucose Monitoring System Drug: Normal Medication Positive Control Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2014
Actual Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


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


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02185755


Locations
Canada, British Columbia
Dr. Hugh Tildesley Inc.
Vancouver, British Columbia, Canada, V6E1M7
Sponsors and Collaborators
Endocrine Research Society
Investigators
Principal Investigator: Hugh D Tildesley, MD Providence Health Care, University of British Columbia

Publications:

Responsible Party: ERS Gap Student, Medical Director, Endocrine Research Society
ClinicalTrials.gov Identifier: NCT02185755     History of Changes
Other Study ID Numbers: IBGMS standalone
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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

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