Ignite Creation Date:
2024-05-05 @ 9:10 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00824694
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2009-01-16
Brief Title:
Impact of Accu-Chek 360 in Veterans With Type 2 Diabetes
Sponsor:
Biomedical Research Institute of New Mexico
Organization:
Biomedical Research Institute of New Mexico
Study Overview
Official Title:
Impact of Accu-Chek 360 View on Practice Patterns and HBA1C in Veterans With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2011-06
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:
To show that a structured treatment plan based upon Accu-Chek 360 View has a favorable effect on physician decision-making and HbA1c for patients on oral hypoglycemic agents OHA or insulin for type 2 diabetes T2D
Hypothesis 1 Compared to controls intervention subjects will undergo a greater number of medication changes and have a lower HbA1 at the conclusion of the study
Hypothesis 2 Higher rates of monitoring at entry will be associated with lower CHO consumption lower percent body fat higher medication compliance and higher physical activity levels
Hypothesis 3 Patients with lower rates of monitoring at entry will have higher rates of depression more likely to have an external locus of control and express greater fear about self-testing
Hypothesis 1 Compared to controls intervention subjects will undergo a greater number of medication changes and have a lower HbA1 at the conclusion of the study
Hypothesis 2 Higher rates of monitoring at entry will be associated with lower CHO consumption lower percent body fat higher medication compliance and higher physical activity levels
Hypothesis 3 Patients with lower rates of monitoring at entry will have higher rates of depression more likely to have an external locus of control and express greater fear about self-testing
Detailed Description:
Primary care providers PCPs will be randomized to intervention and control arms Their T2D patients will be identified by searching computerized pharmacy records for OHA or insulin followed until they are on a stable medical regimen and eligible to participate if their baseline HbA1c is 70 - 95 if on OHA or 75 - 100 if on insulin Two sample frames will be created for intervention patients one of patients on OHA alone and one of patients on insulin alone or in combination with OHA The same procedure will be used to develop corresponding sample frames for control patients OHA patients will be randomly sampled from the intervention and control groups at a ratio of 11 until 174 subjects have been enrolled Insulin patients will be recruited in the same manner until another 174 subjects are recruited At entry patients will have measurements of fat mass insulin-resistance stimulated C-peptide carbohydrate intake and physical activity level
The intervention will consist of targeted SMBG provider training and patient education all of which will be focused on normalizing the most significant glucose abnormalities at any given time SMBG will alternate between 2 strategies glucose profiling and target monitoring Intervention PCPs will use 360 View to identify a patients most significant glucose elevations and devise a treatment plan that includes the medication to be used starting dose dose increment per cycle interval between dose increases monitoring times and frequency goal for the target and stop criteria Separate treatment protocols will be recommended for OHA patients with basal hyperglycemia OHA patients with PP hyperglycemia insulin patients with basal hyperglycemia and insulin patients with PP hyperglycemia Treatment will conform to current standards of practice as defined by package inserts and Micromedex the VAs official on-line drug reference Subjects will repeat the dose titration cycle under the guidance of a case manager until the target is reached maximal recommended doses of medications are used or a stop criterion is met They will then resume glucose profiling to identify the next target This process is repeated until all targets reach their optimal value Intervention subjects will undergo no less than 4 cycles in 48 weeks Control patients will monitor and be treated in the customary manner
The intervention will consist of targeted SMBG provider training and patient education all of which will be focused on normalizing the most significant glucose abnormalities at any given time SMBG will alternate between 2 strategies glucose profiling and target monitoring Intervention PCPs will use 360 View to identify a patients most significant glucose elevations and devise a treatment plan that includes the medication to be used starting dose dose increment per cycle interval between dose increases monitoring times and frequency goal for the target and stop criteria Separate treatment protocols will be recommended for OHA patients with basal hyperglycemia OHA patients with PP hyperglycemia insulin patients with basal hyperglycemia and insulin patients with PP hyperglycemia Treatment will conform to current standards of practice as defined by package inserts and Micromedex the VAs official on-line drug reference Subjects will repeat the dose titration cycle under the guidance of a case manager until the target is reached maximal recommended doses of medications are used or a stop criterion is met They will then resume glucose profiling to identify the next target This process is repeated until all targets reach their optimal value Intervention subjects will undergo no less than 4 cycles in 48 weeks Control patients will monitor and be treated in the customary manner
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