3-Month Trial Observation of A1c Change

Not Applicable

Terminated

• Conditions: Type 2 Diabetes
• Interventions: Other: Internet Communication

• Registration Number: NCT01415271
• Lead Sponsor: Endocrine Research Society

Brief Summary

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.

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

Study Timeline

• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Study Start: 2011-10
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet Intervention	Internet Communication	-

Primary Outcome Measures

Name	Time	Method
HbA1c	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

Name	Time	Method
Frequency of Self-Monitoring	3 months	Measure the frequency of blood glucose self-monitoring of the patients by collecting the total number of tests using the provided meter.
Staff satisfaction	3 months	Measure of hospital staff satisfaction of using the Health-e-Connect platform to help patients communicate with an endocrinologist
unplanned hospitalizations	3 months	A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours

Trial Locations

Locations (1)

Endocrine Research Society; 🇨🇦 Vancouver, British Columbia, Canada