Effect of Internet Therapeutic Intervention on A1C Levels in Type 2 Diabetes Mellitus (DM) on Combination Oral Therapy
|First Received Date ICMJE||February 1, 2010|
|Last Updated Date||June 28, 2011|
|Start Date ICMJE||February 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The primary endpoint is the A1c level or the change in A1c level [ Time Frame: 6 Months ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01060241 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||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 ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effect of Internet Therapeutic Intervention on A1C Levels in Type 2 Diabetes Mellitus (DM) on Combination Oral Therapy|
|Official Title ICMJE||Effect of Internet Therapeutic Intervention on A1C Levels in Type 2 Diabetes Mellitus on Combination Oral Therapy|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Condition ICMJE||Type 2 Diabetes Mellitus|
|Intervention ICMJE||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
|Study Arm (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Suspended|
|Estimated Enrollment ICMJE||50|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||25 Years to 79 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT01060241|
|Other Study ID Numbers ICMJE||T2D Combination-Internet BGM|
|Has Data Monitoring Committee||No|
|Responsible Party||Dr. Hugh Tildesley, Providence Health Care|
|Study Sponsor ICMJE||Endocrine Research Society|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Endocrine Research Society|
|Verification Date||January 2010|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP