3-Month Trial Observation of A1c Change
|ClinicalTrials.gov Identifier: NCT01415271|
Recruitment Status : Terminated (Preliminary exploration of research concept did not prove to be viable.)
First Posted : August 11, 2011
Last Update Posted : August 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Other: Internet Communication||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|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|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
|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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415271
|Canada, British Columbia|
|Endocrine Research Society|
|Vancouver, British Columbia, Canada, V6E 1M7|
|Principal Investigator:||Hugh Tildesley||Providence Health Care, University of British Columbia|