Diabetes Type 2CADSNCT01382264
Use of a Computer-Assisted Decision Support (CADS) System in Management of Patients With Type 2 Diabetes
A study testing Computer Assisted Decision Support in people with Diabetes Type 2, run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
The primary purpose of this study is to determine whether the use of a computer assisted decision support (CADS)system by primary care providers (PCPs) for their patients with type 2 diabetes mellitus (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Computer Assisted Decision Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Oct 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providers
- Non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
- Absence of orders for deployment or permanent change of station
- Willingness to recruit up to 19 patients prior to randomization
- Willingness to deliver "usual care" as defined below in Section 6.3.2.
- Patients
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- Patients with a diagnosis of Type 2 DM of at least three months duration;
- History of inadequate glycemic control (A1C < 7.0% but ≤ 11%) determined by at least two A1C values within the previous 6 months
- Willingness to test blood glucose four or more times each day at least once a week, and 8 times each day for one day per month;
- Willingness to upload their glucometer to transmit data to a central database every 2 weeks
- Access to a land line telephone in order to upload their glucometer data every 2 weeks
- Not using "prandial" regular or a short-acting insulin (e.g. insulin aspart, lispro, glulisine)
- Not using "premixed insulin" (Novolin Mix, Novolog Mix, Humulin Mix, Humalog Mix)
- 18 years of age or older
- Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous six months)
- Not taking or not expected to be taking any oral glucocorticoids except for replacement therapy for those with adrenal insufficiency, amphetamines, anabolic, or weight-reducing agents during the course of the study
- Not receiving chemotherapy or immunosuppressive therapy access to telephone capable of transmitting data for downloading of a glucose meter
Who cannot join
- Providers
- Specialist physicians
- Orders for deployment or permanent change of station
- Unwillingness to recruit up to 19 patients prior to randomization
- No prior experience with management of type 2 diabetes in adults
- Unwillingness to deliver "usual care" as defined below
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- Patients
- Patients with Type 1 diabetes or those with Type 2 on prandial rapid-acting insulin or premixed insulins
- Unwillingness to test blood glucose four or more times a day at least once a week and 8 times a day once a month;
- Unwillingness or inability to receive training in using the technology and/or upload blood glucose data every 2 weeks.
- No access to a land line telephone in order to upload their glucometer data every 2 week
- Inability to communicate in written and spoken English
- Organ (kidney, pancreas, liver) transplant recipients
- Severe impairment of dexterity, vision, or intellectual function
- Pregnancy verified by a urine pregnancy test at baseline in pre-menopausal women. The pregnancy test will be administered by the project officer at each study site.
- Individuals who are not likely to return for the follow-up because they or their sponsors are likely to have a permanent change of station or termination of service before completion of the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
Robert A Vigersky, MD
About this study
Official title: The Use of a Computer-Assisted Decision Support (CADS) System to Improve Outcomes in Patients With Type 2 Diabetes
The primary purpose of this study is to determine whether the use of a computer assisted decision support (CADS)system by primary care providers (PCPs) for their patients with type 2 diabetes mellitus (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1C, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.
Read the detailed description
Diabetes accounts for an enormous fraction of the cost of health care in the United States and presents a major burden on Military Medical Facilities for care of retirees and dependents. There are insufficient endocrinologists and other diabetes specialists to manage all patients with diabetes mellitus (DM) and a significant fraction of these patients have less than optimal control (hemoglobin A1C's [A1Cs] over 7%). Multiple barriers prevent the necessary improvement in glycemic control that would result in savings in lives and costs. The implementation of a telemedicine and web-based approach for patients to send their blood glucose data which, when combined with relevant laboratory, pharmacy, and A1C targets as set individually for each patient by the Primary Care Physician (PCP), triggers a clinical decision support system (DSS) for the providers can be expected to improve quality of care and efficiency of care. The computer assisted decision support (CADS) system has been integrated with the Comprehensive Diabetes Management Program (CDMP), a web-based, multi-platform, interactive patient and provider tool which is currently operative in the Walter Reed Health Care System (WRHCS), Wilford Hall Medical Center (WHMC) at Lackland Air Force Base (AFB), and five community clinics affiliated with the University of Hawaii (UH). This existing infrastructure permits CADS to be tested in a multiple sites that are geographically diverse with diverse patient populations.
This study will test the safety and efficacy of CADS as used by PCPs in a multi-site, ethnically and geographically diverse study in a 12-month, open, prospective, cluster-randomized, controlled clinical trial. The specific aims of the study are to: (1) monitor the impact of the intervention on: a) measures of glycemic control, b) the number of diabetes -related hospitalizations and emergency room visits, c) the control of co-morbidities, hyperlipidemia and hypertension, d) the number of clinic visits, e) the change in the patients' quality of life as a result of the intervention; and (2) evaluate the PCPs' satisfaction with the technology.
We will employ a cluster-randomized, controlled, clinical trial involving 30 PCPs who will each recruit approximately 19 patients from their respective geographic site. After completion of recruitment, PCPs and their patients will be randomly assigned to 1 of 2 "treatment" categories: CADS, or "Usual Care". Input data for use by the CADS system will come from the electronic medical record (laboratory and pharmacy data) and from the PCP who will set goals for each individual patient's glycemic control. Patients will upload blood glucose data through a modem to a password-protected, secure server at least every 2 weeks and receive modification in their treatment regimen at least every three months from their PCP, based in part on the recommendations provided by the CADS system to the PCP. We will compare quantitative outcome measures of glycemic control (the primary outcome is the change in the patient's A1C), blood pressure, and lipid levels from the two treatment groups. In addition, subjective qualitative data from the patients and providers will be obtained.
- Conditions
- Diabetes Type 2
- Being tested
- Computer Assisted Decision Support
- Keywords
- Poorly controlled diabetes Type 2, Computer Assisted Decision Support, Primary Care Providers
- 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.
Computer Assisted Decision SupportOther
Program to provide recommendations for achieving glycemic control in poorly controlled patients with T2 diabetes.
| Study group | Role | What they receive |
|---|---|---|
| CADS | Experimental | Not described Receives: Other: Computer Assisted Decision Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved glycemic control as determined by A1C in a population of patients with inadequately controlled type 2 diabetes mellitus.
The primary purpose of this 12-month, open, "cluster-randomized" trial study is to determine whether the use of a Computer Assisted Decision Support (CADS) System by primary care providers (PCPs) for their patients with type 2 diabetes mellitus (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1C, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.
Measured: One year
Secondary outcomes (4)
Blood pressure
Blood pressure (BP) and lipid levels will change over one year in those patients whose health care providers use CADS.
Measured: 1 year
Lipid levels
This study will determine whether the patients of CADS-enabled providers are more likely to improve specific diabetes-related co-morbidities that contribute to the development of the microvascular and macrovascular complications of diabetes i. Lipid profiles ii. Blood pressure
Measured: 1 year
Number of major and minor hypoglycemic episodes in the intervention and control groups.
The study will determine whether there is a decrease in the number of major and minor hypoglycemic episodesin the patients of CADS-enabled providers compared to patients receiving usual care.
Measured: 1 year
Satisfaction with treatment and quality of life.
This study will determine whether there is an improved satisfaction with treatment and quality of life for patients with DM based on the results of the Diabetes Treatment Satisfaction Questionnaire (DTSQ).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 2Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- 59th Medical Wing, University of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382264
- Sponsor's protocol ID
- 353757
- Acronym
- CADS
- Status last verified
- Jun 2011
- First submitted
- 23 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Computer-Assisted Decision Support (CADS) System to Improve Outcomes in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01382264
- Acronym / sponsor ID
- CADS / 353757
- Conditions
- Diabetes Type 2
- Keywords
- Poorly controlled diabetes Type 2, Computer Assisted Decision Support, Primary Care Providers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Collaborators
- 59th Medical Wing, University of Hawaii
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 27 Jun 2011 (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.
The primary purpose of this study is to determine whether the use of a computer assisted decision support (CADS)system by primary care providers (PCPs) for their patients with type 2 diabetes mellitus (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1C, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.
Detailed description
Diabetes accounts for an enormous fraction of the cost of health care in the United States and presents a major burden on Military Medical Facilities for care of retirees and dependents. There are insufficient endocrinologists and other diabetes specialists to manage all patients with diabetes mellitus (DM) and a significant fraction of these patients have less than optimal control (hemoglobin A1C's [A1Cs] over 7%). Multiple barriers prevent the necessary improvement in glycemic control that would result in savings in lives and costs. The implementation of a telemedicine and web-based approach for patients to send their blood glucose data which, when combined with relevant laboratory, pharmacy, and A1C targets as set individually for each patient by the Primary Care Physician (PCP), triggers a clinical decision support system (DSS) for the providers can be expected to improve quality of care and efficiency of care. The computer assisted decision support (CADS) system has been integrated with the Comprehensive Diabetes Management Program (CDMP), a web-based, multi-platform, interactive patient and provider tool which is currently operative in the Walter Reed Health Care System (WRHCS), Wilford Hall Medical Center (WHMC) at Lackland Air Force Base (AFB), and five community clinics affiliated with the University of Hawaii (UH). This existing infrastructure permits CADS to be tested in a multiple sites that are geographically diverse with diverse patient populations.
This study will test the safety and efficacy of CADS as used by PCPs in a multi-site, ethnically and geographically diverse study in a 12-month, open, prospective, cluster-randomized, controlled clinical trial. The specific aims of the study are to: (1) monitor the impact of the intervention on: a) measures of glycemic control, b) the number of diabetes -related hospitalizations and emergency room visits, c) the control of co-morbidities, hyperlipidemia and hypertension, d) the number of clinic visits, e) the change in the patients' quality of life as a result of the intervention; and (2) evaluate the PCPs' satisfaction with the technology.
We will employ a cluster-randomized, controlled, clinical trial involving 30 PCPs who will each recruit approximately 19 patients from their respective geographic site. After completion of recruitment, PCPs and their patients will be randomly assigned to 1 of 2 "treatment" categories: CADS, or "Usual Care". Input data for use by the CADS system will come from the electronic medical record (laboratory and pharmacy data) and from the PCP who will set goals for each individual patient's glycemic control. Patients will upload blood glucose data through a modem to a password-protected, secure server at least every 2 weeks and receive modification in their treatment regimen at least every three months from their PCP, based in part on the recommendations provided by the CADS system to the PCP. We will compare quantitative outcome measures of glycemic control (the primary outcome is the change in the patient's A1C), blood pressure, and lipid levels from the two treatment groups. In addition, subjective qualitative data from the patients and providers will be obtained.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CADS | Experimental | Other: Computer Assisted Decision Support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Providers
- Non-specialist physician (general internist or family practitioner), nurse practitioner, physicians assistant
- Absence of orders for deployment or permanent change of station
- Willingness to recruit up to 19 patients prior to randomization
- Willingness to deliver "usual care" as defined below in Section 6.3.2.
Key exclusion criteria (16 listed)
- Providers
- Specialist physicians
- Orders for deployment or permanent change of station
- Unwillingness to recruit up to 19 patients prior to randomization
- No prior experience with management of type 2 diabetes in adults
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 |
|---|---|---|
| Computer Assisted Decision SupportProgram to provide recommendations for achieving glycemic control in poorly controlled patients with T2 diabetes. | Other | CADS |
Primary outcome
Improved glycemic control as determined by A1C in a population of patients with inadequately controlled type 2 diabetes mellitus.
Time frame: One year
The primary purpose of this 12-month, open, "cluster-randomized" trial study is to determine whether the use of a Computer Assisted Decision Support (CADS) System by primary care providers (PCPs) for their patients with type 2 diabetes mellitus (T2DM) changes the quality of care relative to a "usual care" group in terms of objective outcome measures of glycemic control (e.g., A1C, mean blood glucose, frequency of hypoglycemic episodes) and in terms of subjective ratings by patients.
4 secondary outcomes
Blood pressure
Time frame: 1 year
Lipid levels
Time frame: 1 year
Number of major and minor hypoglycemic episodes in the intervention and control groups.
Time frame: 1 year
Satisfaction with treatment and quality of life.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Assisted Decision Support in people with Diabetes Type 2, run by Walter Reed Army Medical Center at 1 site 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 17 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 27 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 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert A. Vigersky, MD (202.782.6750, robert.vigersky@amedd.army.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved glycemic control as determined by A1C in a population of patients with inadequately controlled type 2 diabetes mellitus. (time frame: One year). 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 27 Jun 2011.