Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207207
Status:
COMPLETED
Last Update Posted:
2009-02-11
First Post:
2005-09-13
Brief Title:
Self Monitoring of Blood Glucose With Finger Tip vs Alternate Site Sampling Effect on Long Term Glycemic Control
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
Randomized Trial to Assess the Effect of Using Alternate Site Blood Glucose Testing Versus Finger-Tip Testing on Long-Term Glycemic Control
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to assess the effect of using ASBG alternate site blood glucose versus FTBG finger tip blood glucose testing on long-term glycemic control in diabetics Since ASBG measurements appear to lag behind FSBG measurements at times of changing glucose concentration it is possible that ASBG measurements will yield lower postprandial readings than FTBG potentially causing a negative impact on long-term control It is also possible that since ASBG is reportedly more comfortable than FTBG testing its use might improve adherence to testing and improve long term control
Detailed Description:
Patients undergo an initial screening visit Inclusion criteria include adults 18 -70 years of age with type II diabetes currently using insulin and recording SMBG measurements Exclusion criteria include history of severe hypoglycemic episodes current use of ASBG measurements serious co-morbid illness or pregnancy For eligible subjects baseline data including HbA1C is obtained The goal for enrollment is 176 subjects Subjects are randomized into either a fingertip or an arm-testing group within strata of baseline HbA1C Each subject who does not already have one receives a One Touch Ultra SMBG device All subjects receive training in the use of this device but for those in the arm-testing group this includes training on obtaining samples from the forearm Arm- testing subjects are encouraged to use arm testing as much as possible but to use finger testing if they are not able to obtain a sample from the arm All subjects are asked to perform SMBG testing before breakfast before dinner and 2 hours after dinner and to complete diaries of all SMBG readings At 1 3 and 5 months after the training visit subjects see a diabetes provider who makes adjustments in the therapeutic regimen based on the SMBG measurements as they would during routine diabetes management Diary sheets are then collected and the data they contain is entered into a database At months 2 4 and 7 subjects present for a visit to drop off their diary sheets At months 4 and 7 they have blood drawn for HbA1C measurement The principal outcome variable is level of diabetic control as measured by 7-month HbA1c The means for each group will be compared and we will test the hypothesis that glycemic control as represented by 7-month HbA1C is not worse for the ASBG group than the FTBG group Secondary outcome variables are compliance with testing and number of hypoglycemic episodes
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Contract 233-02-0077 | None | None | None |