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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:
ClinicalTrials.gov Identifier:
NCT01415271
First Posted: August 11, 2011
Last Update Posted: August 13, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Hugh Tildesley, Endocrine Research Society
  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: None (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:


Further study details as provided by Dr. Hugh Tildesley, Endocrine Research Society:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 0 and 3 months ]
    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 ]
    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 ]
    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 ]
    A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours


Enrollment: 10
Study Start Date: October 2011
Study Completion Date: September 2012
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): 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:
Clement M and Leung F. Diabetes and the Frail Elderly in Long-term Care. Can J Diabetes. 2009;33(2):114-121.
Tildesley HD, Mazanderani, AB, Chan, JHM et al. Efficacy of A1c Reduction Using Internet Intervention in Patients with Type 2 Diabetes Treated with Insulin. Can J Diabetes. 2011; 35(3): 250-253.

Responsible Party: Dr. Hugh Tildesley, Director, Endocrine Research Society
ClinicalTrials.gov Identifier: NCT01415271     History of Changes
Other Study ID Numbers: Point Grey Trial
First Submitted: August 10, 2011
First Posted: August 11, 2011
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by Dr. Hugh Tildesley, Endocrine Research Society:
diabetes
A1c
internet
long term care