Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 1:05 AM
Study NCT ID:
NCT01162694
Status:
SUSPENDED
Last Update Posted:
2014-09-11
First Post:
2010-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Internet Blood Glucose Monitoring System and Continuous Glucose Monitoring System
Sponsor:
Endocrine Research Society
Organization:
Study Overview
Official Title:
Protocol: Comparing the Effect of Using an Internet-Based Glucose Monitoring System Versus the Continuous Glucose Monitoring System on HbA1c Levels in Type 2 DM
Status:
SUSPENDED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was expanded and included in another study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Management of type 2 diabetes is an ongoing challenge for patients and their doctors. In order to prevent short and long term complications, patients need to monitor and control their blood sugar levels. In addition, they may need to have an ongoing communication with their doctor in order to modify treatment. In this study the investigators wish to compare two systems of monitoring and communication of blood sugar levels. The first is the use of continuous glucose monitoring system and the second is the use of an Internet-based glucose monitoring system. The investigators want to compare their effect and/or benefits.
Detailed Description:
Purpose: To compare the benefits of the Internet-based glucose monitoring system with the Continuous Glucose monitoring system in patients with type 2 diabetes mellitus.
Hypothesis:The investigators propose that the benefits from the Internet-based glucose monitoring system (IBGMS) will be comparable to the benefits of the Continuous Glucose monitoring system (CGMS) for patients with type 2 DM.
Justification: Half of the subject will be on the standard treatment, which 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. They will also use the internet system to report their glucose readings,which will allow the health care professions to view the results and provide feedback. The other half will use the continuous glucose monitoring system, which will involve a minimum of testing blood glucose at least 2 times a day to calibrate the sensor, performing 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;
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 (IBGMS and CGMS). There is an equal chance, a 50/50 chance, of being placed in either group.
The IBGMS group will receive standard care and will be asked to perform self-blood glucose monitoring 3 times daily for 6 months. The IBGMS group will also be asked to report their blood glucose reading every 2 weeks through an Internet based glucose monitoring system. The IBGMS group will make visits to the endocrinologist every 3 months with A1c and serum creatinine measurements at 3-month intervals for 6 months.
The CGMS group will also receive standard care and will be asked to perform self-blood glucose monitoring at least 2 times a day for 6 months to calibrate the sensor.The CGMS group will also be using the internet system to generate a report of their blood glucose readings and can be used at the patient's own preference. Their readings will also be sent to the endocrinologist for feedback every 2 weeks. The CGMS group will 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 SMBG (Self monitored blood glucose) 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.
Hypothesis:The investigators propose that the benefits from the Internet-based glucose monitoring system (IBGMS) will be comparable to the benefits of the Continuous Glucose monitoring system (CGMS) for patients with type 2 DM.
Justification: Half of the subject will be on the standard treatment, which 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. They will also use the internet system to report their glucose readings,which will allow the health care professions to view the results and provide feedback. The other half will use the continuous glucose monitoring system, which will involve a minimum of testing blood glucose at least 2 times a day to calibrate the sensor, performing 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;
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 (IBGMS and CGMS). There is an equal chance, a 50/50 chance, of being placed in either group.
The IBGMS group will receive standard care and will be asked to perform self-blood glucose monitoring 3 times daily for 6 months. The IBGMS group will also be asked to report their blood glucose reading every 2 weeks through an Internet based glucose monitoring system. The IBGMS group will make visits to the endocrinologist every 3 months with A1c and serum creatinine measurements at 3-month intervals for 6 months.
The CGMS group will also receive standard care and will be asked to perform self-blood glucose monitoring at least 2 times a day for 6 months to calibrate the sensor.The CGMS group will also be using the internet system to generate a report of their blood glucose readings and can be used at the patient's own preference. Their readings will also be sent to the endocrinologist for feedback every 2 weeks. The CGMS group will 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 SMBG (Self monitored blood glucose) 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: