Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 5:20 AM
Study NCT ID:
NCT00824694
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2009-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Accu-Chek 360 in Veterans With Type 2 Diabetes
Sponsor:
Biomedical Research Institute of New Mexico
Organization:
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 (PCP's) 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 7.0 - 9.5% if on OHA or 7.5 - 10.0% 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 1:1 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 PCP's will use 360 View to identify a patient's most significant glucose elevation(s) 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 VA's 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 PCP's will use 360 View to identify a patient's most significant glucose elevation(s) 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 VA's 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:
True
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?: