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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

August 10, 2011
September 28, 2012
October 2011
September 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01415271 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
3-Month Trial Observation of A1c Change
Assessment of an Internet Blood Glucose Management Program in a Chronic Care Hospital

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.

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

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Type 2 Diabetes
Other: Internet Communication
bi-weekly communication of blood sugars using an internet platform between patients with type 2 diabetes and an endocrinologist
Experimental: Internet Intervention
Intervention: Other: Internet Communication

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01415271
Point Grey Trial
No
Dr. Hugh Tildesley, Endocrine Research Society
Endocrine Research Society
Not Provided
Principal Investigator: Hugh Tildesley Providence Health Care, University of British Columbia
Endocrine Research Society
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP