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Impact of Accu-Chek 360 in Veterans With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
New Mexico VA Healthcare System
Carl T. Hayden VA Medical Center
Southern Arizona VA Health Care System
Information provided by:
Biomedical Research Institute of New Mexico
ClinicalTrials.gov Identifier:
NCT00824694
First received: January 16, 2009
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Other: Targeted Self-Monitoring Of Blood Glucose (SMBG)
Other: Provider Training
Other: Patient Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Accu-Chek 360 View on Practice Patterns and HBA1C in Veterans With Type 2 Diabetes.

Resource links provided by NLM:


Further study details as provided by Biomedical Research Institute of New Mexico:

Primary Outcome Measures:
  • Principal endpoints will be measured 48 weeks after group assignment and include the number of medication changes and HbA1c. Interim analysis will include HbA1c measurement at 3 mont intervals. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoints include changes in patient attitudes toward SMBG, daily carbohydrate consumption, physical activity level, BMI, and medication compliance (for subjects on OHA). [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 348
Study Start Date: March 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention
The intervention will consist of targeted SMBG, provider training and patient education-all of which are 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 380 View to identify a patient's most significant glucose elevations(s) and devise a treatment plan that includes drug type, dose increases, monitoring times, goal for the target, and stop criteria.
Other: Targeted Self-Monitoring Of Blood Glucose (SMBG)
SMBG will alternate between 2 strategies: glucose profiling and target monitoring.
Other: Provider Training
Focused on normalizing the most significant glucose abnormalities at any given time.
Other: Patient Education
Focused on normalizing the most significant glucose abnormalities at any given time.
Active Comparator: Control Arms
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. Control patients will monitor and be treated in the customary manner.
Other: Targeted Self-Monitoring Of Blood Glucose (SMBG)
SMBG will alternate between 2 strategies: glucose profiling and target monitoring.
Other: Provider Training
Focused on normalizing the most significant glucose abnormalities at any given time.
Other: Patient Education
Focused on normalizing the most significant glucose abnormalities at any given time.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a primary care provider
  • Diabetes diagnosed after age 35
  • Eat 3 meals daily and ≤ 1 snack
  • If on OHA, have willingness to start insulin

Exclusion Criteria:

  • Type 1 diabetes or DKA
  • On insulin pump or CGM
  • Preference for language other than English
  • Can't or won't monitor
  • Unfavorable occupation or living arrangements
  • Terminal illness
  • Active alcoholism or substance abuse
  • Severe depression
  • Chronic liver disease
  • Pituitary or adrenal dysfunction
  • Immunosuppression
  • Hct < 35
  • Creatinine ≥ 2.5
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824694

Locations
United States, Arizona
Carl T. Hayden VAMC
Phoenix, Arizona, United States, 85012
Southern Arizona VA Healthcare System
Tucson, Arizona, United States, 85723
United States, New Mexico
New Mexico VA Health Care System
Albuquerque, New Mexico, United States, 87108
Sponsors and Collaborators
Biomedical Research Institute of New Mexico
New Mexico VA Healthcare System
Carl T. Hayden VA Medical Center
Southern Arizona VA Health Care System
Investigators
Principal Investigator: Glen H Murata, M.D. New Mexico VA Health Care System
  More Information

No publications provided

Responsible Party: Glen H. Murata, M.D., New Mexico VA Health Care System
ClinicalTrials.gov Identifier: NCT00824694     History of Changes
Other Study ID Numbers: Investigator Initiated
Study First Received: January 16, 2009
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Biomedical Research Institute of New Mexico:
Glucose
Diabetes Mellitus, Type 2
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 19, 2014