Type 2 DiabetesNCT00824694
Impact of Accu-Chek 360 in Veterans With Type 2 Diabetes
A study testing Targeted Self-Monitoring Of Blood Glucose (SMBG), Provider Training and Patient Education in people with Type 2 Diabetes, run by Biomedical Research Institute of New Mexico at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Targeted Self-Monitoring Of Blood Glucose (SMBG), Provider Training and Patient Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- Active alcoholism or substance abuse
- Severe depression
- Chronic liver disease
- Pituitary or adrenal dysfunction
- Immunosuppression
- Hct < 35
- Creatinine ≥ 2.5
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108
Carl T. Hayden VAMC
Phoenix, Arizona, 85012
Southern Arizona VA Healthcare System
Tucson, Arizona, 85723
About this study
Official title: Impact of Accu-Chek 360 View on Practice Patterns and HBA1C in Veterans With Type 2 Diabetes.
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.
Read more
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Targeted Self-Monitoring Of Blood Glucose (SMBG), Provider Training, Patient Education
- Keywords
- Glucose, Diabetes Mellitus, Type 2, HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Self-Monitoring Of Blood Glucose (SMBG)Other
SMBG will alternate between 2 strategies: glucose profiling and target monitoring.
Provider TrainingOther
Focused on normalizing the most significant glucose abnormalities at any given time.
Patient EducationOther
Focused on normalizing the most significant glucose abnormalities at any given time.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 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. Receives: Other: Targeted Self-Monitoring Of Blood Glucose (SMBG); Other: Provider Training; Other: Patient Education |
| Control Arms | Active comparator | 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. Receives: Other: Targeted Self-Monitoring Of Blood Glucose (SMBG); Other: Provider Training; Other: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (1)
Secondary endpoints include changes in patient attitudes toward SMBG, daily carbohydrate consumption, physical activity level, BMI, and medication compliance (for subjects on OHA).
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biomedical Research Institute of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- New Mexico VA Healthcare System, Carl T. Hayden VA Medical Center, Southern Arizona VA Health Care System
- Investigators
- Glen H Murata, M.D., Principal investigator, New Mexico VA Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824694
- Sponsor's protocol ID
- Investigator Initiated
- Status last verified
- Jun 2011
- First submitted
- 16 Jan 2009
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Accu-Chek 360 View on Practice Patterns and HBA1C in Veterans With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT00824694
- Acronym / sponsor ID
- Investigator Initiated
- Conditions
- Type 2 Diabetes
- Keywords
- Glucose, Diabetes Mellitus, Type 2, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Biomedical Research Institute of New MexicoUniversity, hospital or other
- Collaborators
- New Mexico VA Healthcare System, Carl T. Hayden VA Medical Center, Southern Arizona VA Health Care System
- Study start
- Mar 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Targeted Self-Monitoring Of Blood Glucose (SMBG), Other: Provider Training, Other: Patient EducationThe 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. |
| Control Arms | Active comparator | Other: Targeted Self-Monitoring Of Blood Glucose (SMBG), Other: Provider Training, Other: Patient EducationSubjects 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Self-Monitoring Of Blood Glucose (SMBG)SMBG will alternate between 2 strategies: glucose profiling and target monitoring. | Other | Control Arms, Intervention |
| Provider TrainingFocused on normalizing the most significant glucose abnormalities at any given time. | Other | Control Arms, Intervention |
| Patient EducationFocused on normalizing the most significant glucose abnormalities at any given time. | Other | Control Arms, Intervention |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glen H Murata, M.D. principal investigator
New Mexico VA Healthcare System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Self-Monitoring Of Blood Glucose (SMBG), Provider Training and Patient Education in people with Type 2 Diabetes, run by Biomedical Research Institute of New Mexico at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2011.