Effect of Internet Therapeutic Intervention on A1C Levels in Type 2 Diabetes Mellitus (DM) on Combination Oral Therapy

This study has suspended participant recruitment.
(Other projects warranted more attention)
Sponsor:
Information provided by:
Endocrine Research Society
ClinicalTrials.gov Identifier:
NCT01060241
First received: February 1, 2010
Last updated: June 28, 2011
Last verified: January 2010
  Purpose

This project will test the effectiveness of an Internet based glucose monitoring system on the A1C levels of patients with type 2 diabetes. All of the patients are given a meter and test strips to test their blood glucose levels, however, half of them will be required to also upload their meter onto the Internet which can then be viewed by their endocrinologist. The doctor can then send a message back to the patient and comment on the readings. The effect of the ongoing communication will be measured by the changes in the glucose levels (HbA1C) over 3 and 6 months.


Condition Intervention
Type 2 Diabetes Mellitus
Other: Internet Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effect of Internet Therapeutic Intervention on A1C Levels in Type 2 Diabetes Mellitus on Combination Oral Therapy

Resource links provided by NLM:


Further study details as provided by Endocrine Research Society:

Primary Outcome Measures:
  • The primary endpoint is the A1c level or the change in A1c level [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary endpoints include severe hypoglycemia defined as requiring external aid, hospital admissions for any CVD related intervention, and adverse events such as unplanned hospitalizations for any cause that last more than 24 hours [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2010
Arms Assigned Interventions
Experimental: Internet Intervention
The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.
Other: Internet Intervention
The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.
Other Name: Remote Blood Glucose Monitoring System
No Intervention: Standard Care
This arm will receive standard care which includes self-blood glucose monitoring at least 3 times daily and visit to the endocrinologist at least once every 3 months.

Detailed Description:

Purpose: To determine whether use of an Internet-based glucose monitoring system (ALR Technologies Inc.) improves Hemoglobin A1c (HbA1c) levels in patients with type 2 diabetes mellitus treated with 2 or more oral anti-diabetic medication.

Hypothesis: We propose that the standardized encounters using the Internet will improve the outcome of treatment for patients with type 2 DM.

Justification: An important aspect of diabetes care is the self-monitoring of blood glucose (SMBG) levels in order to assess the effectiveness of treatment and to modify the treatment to achieve the desirable glucose levels. All patients with type 2 DM are recommended to perform SMBG. However, it often requires intervention by health professionals in order to prevent the immediate and serious complications of hyper or hypoglycemia. The frequent SMBG and effective interventions by the health professionals may eventually allow tighter control of blood glucose levels and delay or prevent the complications associated with diabetes.

Objectives: We propose to measure HbA1c levels at the beginning of the study and compare this with HbA1c levels at three and six months after initiating Internet-based blood glucose monitoring system (IBMS).

Research Method: Fifty patients will be randomized equally (a 50/50 chance) to either conventional therapy or the use of the Internet blood glucose monitoring system.

Conventional therapy (Control group) will consist of general care comprising of SMBG 3 or more times per day and visits to the endocrinologist at 3-month intervals with HbA1c, cholesterols, and serum creatinine determinations at 3-month intervals for 6 months.

Those patients randomized to the Internet system (Intervention group) will be required to perform SMBG 3 or more times per day and to upload their metered glucose values online every 2 weeks to be reviewed by the doctor. As well, there will be visits to the endocrinologist every 3 months with HbA1c, cholesterols, and serum creatinine measurements at 3-month intervals for 6 months.

Statistical Analysis: The primary endpoint is the HbA1c level or the change in A1c level. The secondary endpoints include severe hypoglycemia defined as requiring external aid, hospital admissions for any CVD related intervention, and adverse events such as unplanned hospitalizations for any cause that last more than 24 hours. For each group, A1C levels before the start of study will be compared to A1C levels 3 and 6 months after the start of the study. Paired t-tests and random effects models (longitudinal analyses) will examine differences in A1C values before and after the study duration. Unpaired, independent t-tests will be done to examine the difference in A1C values between the two groups before and after the interventions. Planned sample size is 50.

  Eligibility

Ages Eligible for Study:   25 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes patients treated with 2 or more oral anti-diabetic medication
  • A1C >7%
  • >25 years of age
  • Willingness to test blood glucose levels a minimum of 3 times daily
  • Willingness to be randomized
  • Trained in self blood glucose monitoring
  • Internet Access

Exclusion Criteria:

  • Patients who do not meet the inclusion criteria or are not willing to participate will not be included in the study.
  • In addition patients with the potential to become pregnant or patients using medications known to influence control of diabetes (eg steroids systemic or inhaled) are excluded from the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060241

Locations
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Endocrine Research Society
Investigators
Principal Investigator: Hugh D Tildesley, MD Providence Health Care, University of British Columbia
  More Information

Publications:
Responsible Party: Dr. Hugh Tildesley, Providence Health Care
ClinicalTrials.gov Identifier: NCT01060241     History of Changes
Other Study ID Numbers: T2D Combination-Internet BGM
Study First Received: February 1, 2010
Last Updated: June 28, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Endocrine Research Society:
Remote Blood Glucose Monitoring System, Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014