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

Purpose: To determine whether use of an Internet-based glucose monitoring system improves A1C levels in patients with type 2 diabetes mellitus.

Hypothesis:We propose that the standardized encounters between the patient and the health care profession using the Internet will improve the outcome of treatment for patients with type 2 DM.

Justification:The standard treatment will involve glucose monitoring by testing blood glucose 3 times daily, performing a laboratory test of blood hemoglobin every three months, and visiting the doctor every three months for standard care. All of the subjects will be under standard care; however, half will also use the Internet system to report glucose readings which will allow the health care professional to view the results and to provide feedback.

Research Method: Type 2 diabetes patients who satisfy the inclusion criteria will be recruited from St. Paul's Diabetes Teaching and Training Centre. They will be randomized into 2 groups (Intervention and Control). There is an equal chance, a 50/50 chance, of being placed in either group. The control subject group will receive standard care and will be asked to perform self-blood glucose monitoring 3 times daily for 6 months. The control subject group will also make visits to the endocrinologist every 3 months with laboratory test of A1c and serum creatinine measurements at 3-month intervals for 6 months.

The Intervention group will also receive standard care and will be asked to perform self-blood glucose monitoring 3 times daily for 6 months. However, the Intervention group will also be asked to report their blood glucose reading every 2 weeks through an Internet based glucose monitoring system. The Intervention group will also make visits to the endocrinologist every 3 months with A1c and serum creatinine measurements at 3-month intervals for 6 months. The laboratory measurements of both groups will be recorded and used for data analysis.

Statistical Analysis: The primary endpoint is the A1c 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. Patients who do not have the required number of SBGM tests performed or patients requiring new laser therapy will be asked to discontinue the study.

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. The planned sample size is 50.

Inclusion criteria

• Type 2 diabetes patients treated with insulin
• A1C 7-11%
• >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.