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3-Month Trial Observation of A1c Change

This study has been terminated.
(Preliminary exploration of research concept did not prove to be viable.)
Sponsor:
Information provided by (Responsible Party):
Dr. Hugh Tildesley, Endocrine Research Society
ClinicalTrials.gov Identifier:
NCT01415271
First received: August 10, 2011
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

The incidence of type 2 diabetes in long term care facilities has been approximated at 25% with barriers to treatment including untimely access to a specialist and improper/poor adherence to insulin regimes. This 3 month trial will investigate the efficacy of improving overall glycemic control by using an internet blood glucose reporting system to facilitate bi-weekly consultations between long term care facility patients with type 2 diabetes and an endocrinologist.


Condition Intervention
Type 2 Diabetes
 Other: Internet Communication

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Assessment of an Internet Blood Glucose Management Program in a Chronic Care Hospital

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Endocrine Research Society:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 0 and 3 months ] [ Designated as safety issue: No ]
    Hemoglobin A1c will be measure at 0 and 3 months to determine the efficacy of the internet blood glucose monitoring system as measured by change in glycemic control.


Secondary Outcome Measures:
  • Staff satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measure of hospital staff satisfaction of using the Health-e-Connect platform to help patients communicate with an endocrinologist

  • Frequency of Self-Monitoring [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Measure the frequency of blood glucose self-monitoring of the patients by collecting the total number of tests using the provided meter.

  • unplanned hospitalizations [ Time Frame: 3 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


Estimated Enrollment: 10
Study Start Date: October 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Internet Intervention Other: Internet Communication
bi-weekly communication of blood sugars using an internet platform between patients with type 2 diabetes and an endocrinologist

Detailed Description:

Purpose: This project will investigate the benefits (as measured by change in the primary outcome measure hemoglobin A1c) of bi-weekly reporting of blood sugar values for patients with type 2 diabetes in long term care facilities.

Hypothesis: Our hypothesis is bi-weekly reporting will result in a reduction in A1c after 3 months.

Justification: Elevated A1c values increase risk of health complications for people with type 2 diabetes.

Objectives: Improved type 2 diabetes management for patients in long term care facilities.

Research Methods: Patients who meet the inclusion / exclusion criteria and are interested in participating in the study will self-identify to the research coordinator. Consent will be done in person with any questions answered. Strips and blood glucose meters will be provided. Blood glucose values and testing frequency will be recorded using the internet reporting system Heath-e-Connect. HbA1c, serum creatinine and demographic data will be collected at 0 and 3 months to determine effect of bi-weekly remote communication of blood glucose with an endocrinologist.

Statistical Analysis: HbAlc values at 0 and 3 months will be compared using an unpaired t-test to measure the effect of the intervention

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type II diabetes mellitus patients at Point Grey Private Hospital
  • Trained in self-blood glucose monitoring
  • Willingness to test blood glucose levels a minimum of 3 times daily
  • Willingness to be trained on IBGMS

Exclusion Criteria:

  • Patients with medical conditions that may affect their study participation or results will be excluded.
  • Patients currently being treated with steroid medication
  • Patients that have impaired liver function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415271

Locations
Canada, British Columbia
Endocrine Research Society
Vancouver, British Columbia, Canada, V6E 1M7
Sponsors and Collaborators
Endocrine Research Society
Investigators
Principal Investigator: Hugh Tildesley Providence Health Care, University of British Columbia
  More Information

Publications:

Responsible Party: Dr. Hugh Tildesley, Director, Endocrine Research Society
ClinicalTrials.gov Identifier: NCT01415271     History of Changes
Other Study ID Numbers: Point Grey Trial
Study First Received: August 10, 2011
Last Updated: September 28, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Endocrine Research Society:
diabetes
A1c
internet
long term care

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

ClinicalTrials.gov processed this record on May 16, 2013