Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatments internet-based glucose monitoring system, normal medication positive control
Sponsor Endocrine Research Society
Start date August 2014
End date August 2016
Trial size 60 participants
Trial identifier NCT02185755, IBGMS standalone

Summary

Managing blood sugar levels is important for patients with type 2 diabetes (T2DM) to minimize health problems and complications. One way for patients to notify doctors and receive feedback about their blood sugar management is through an online system. As Internet-based glucose monitoring systems (IBGMS) have already been shown to be effective, the investigators hypothesize that IBGMS is effective as an intervention even when limiting feedback to non-medicine related changes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
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 provide feedback limited to non-medicine related comments and suggestions.
internet-based glucose monitoring system Internet Blood Glucose Monitoring System
(Other)
The subjects will be prescribed a new medication as appropriate for normal therapy. This group will receive no biweekly feedback nor require to report online, but will see the endocrinologist every 3 months up to 6 months.
normal medication positive control

Primary Outcomes

Measure
HbA1c Levels before and after intervention
time frame: 6 months

Secondary Outcomes

Measure
The secondary endpoint include severe hypoglycemia defined as requiring external aid (hospital or other).
time frame: 6 months
A secondary endpoint includes adverse events such as unplanned hospitalizations for any cause that last more than 24 hours
time frame: 6 months
HbA1c levels remain at 8% or higher
time frame: 3 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Type 2 diabetes patients being treated with oral hypoglycemic agents - HbA1c > 8% - Willingness to test blood glucose levels a minimum of 3 times daily - Willingness to be trained on using the Internet-Based Glucose Monitoring System - Willingness to be randomized - Trained in self-blood glucose monitoring - Internet access on a computer - No prior use or training on IBGMS Exclusion Criteria: - Patient with medical conditions that may affect their study participation or results will be excluded. - Patients using medications known to influence control of diabetes (eg steroids systemic or inhaled) - Liver disease (AST (aspartate aminotransferase) or ALT (alanine aminotransferase) levels > 2.5 times the reference level) - Renal insufficient with a serum creatinine level > 200 μmol/L

Additional Information

Official title Investigating if an Internet-Based Glucose Monitoring System is as Effective as Medication at Reducing HbA1c Levels in Type 2 Diabetes Mellitus
Principal investigator Hugh D Tildesley, MD
Description 1. Purpose: To determine the effectiveness of an Internet-based glucose monitoring system (IBGMS) in the absence of medication changes. 2. Hypothesis: IBGMS without medication changes is comparable to conventional medication at reducing HbA1c levels over 8% in patients with T2DM. 3. Justification: Patients with T2DM having elevated HbA1c levels may be prescribed additional medications to help manage their blood sugar levels, which include oral hypoglycemic agents and/or insulin. As IBGMS has been shown to be effective in reducing HbA1c in T2DM, there is an opportunity to determine whether if this system could be used as an alternative to medication. The benefits would include reduced side effects as a result of substituting for the effects of medication, as well as reduced financial costs associated with acquiring medication. Considering that IBGMS increases the frequency at which patients receive feedback to change medications as compared to typical treatment, the risk is as typical for a patient opting for no medication changes for the same period of time. 4. Objectives: The primary end-point is to determine if patients using IBGMS have reduced HbA1c values at followup, and to compare the reduction to the control group on typical medications. 5. Research Method: 120 patients with T2DM satisfying the inclusion criteria will be recruited and have baseline HbA1c established through regular lab blood tests. They will be randomized into one of two groups, one that will be trained to use IBGMS and one control group going on an appropriate additional medication. The IBGMS group will be asked to report their blood sugars to their endocrinologist biweekly and receive feedback for each report. No medication changes will be offered in the feedback, but lifestyle or dietary recommendations may be included. The control group will be asked to take their new medications as indicated by their endocrinologist. Both groups will have followup visits with their endocrinologist at 3 and 6 months, and will also have blood tests done at those time points checking their HbA1c levels. The effectiveness of both interventions will be evaluated individually and against each other. For the IBGMS group, a rescue secondary endpoint occurs if a subject maintains an HbA1c level at or greater than 8% after 3 months; the subject will be withdrawn from the study and put under standard care. 6. Statistical Analysis: The sample size was calculated to be 120 by estimating mean differences and standard deviations using data from previous studies. For the calculation the statistical power was 0.80 and alpha of 0.05.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Endocrine Research Society.