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.

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Internet Communication

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6E 1M7
      • Endocrine Research Society

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	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.	0 and 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Endocrine Research Society
• Investigators: Principal Investigator: Hugh Tildesley, Providence Health Care, University of British Columbia

Publications and helpful links

General Publications

• Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.
• Clement M and Leung F. Diabetes and the Frail Elderly in Long-term Care. Can J Diabetes. 2009;33(2):114-121.
• Austin MM, Haas L, Johnson T, Parkin CG, Parkin CL, Spollett G, Volpone MT. Self-monitoring of blood glucose: benefits and utilization. Diabetes Educ. 2006 Nov-Dec;32(6):835-6, 844-7. doi: 10.1177/0145721706295873. No abstract available.
• American Diabetes Association. Standards of medical care in diabetes--2008. Diabetes Care. 2008 Jan;31 Suppl 1:S12-54. doi: 10.2337/dc08-S012. No abstract available.
• Karter AJ, Ackerson LM, Darbinian JA, D'Agostino RB Jr, Ferrara A, Liu J, Selby JV. Self-monitoring of blood glucose levels and glycemic control: the Northern California Kaiser Permanente Diabetes registry. Am J Med. 2001 Jul;111(1):1-9. doi: 10.1016/s0002-9343(01)00742-2.
• Hirsch IB, Bode BW, Childs BP, Close KL, Fisher WA, Gavin JR, Ginsberg BH, Raine CH, Verderese CA. Self-Monitoring of Blood Glucose (SMBG) in insulin- and non-insulin-using adults with diabetes: consensus recommendations for improving SMBG accuracy, utilization, and research. Diabetes Technol Ther. 2008 Dec;10(6):419-39. doi: 10.1089/dia.2008.0104.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimate): August 11, 2011

Study Record Updates

• Last Update Posted (Estimate): August 13, 2015
• Last Update Submitted That Met QC Criteria: August 10, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: diabetes; internet; A1c; long term care
• Other Study ID Numbers: Point Grey Trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No