Type II Diabetes MellitusCADSNCT01648244
The Use of a Computer Program to Help Primary Care Providers Treat Patients With Type 2 Diabetes
A study testing Computer-Assisted Decision Support in people with Type II Diabetes Mellitus, run by Walter Reed National Military Medical Center at 1 site in United States.
Trial summary
The primary purpose of this study is to determine whether the use of CADS by primary care providers (PCPs) for their patients with type 2 diabetes (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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- Computer-Assisted Decision Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 in Section 6.3.2 of the protocol.
Who cannot join
- 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 in Section 6.3.2 of the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: The Use of a Computer Assisted Diabetes Decision Support (CADS) System to Improve Outcomes in Patients With Type 2 Diabetes Who Are Treated by Primary Care Providers
The primary purpose of this study is to determine whether the use of CADS by primary care providers (PCPs) for their patients with type 2 diabetes (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
The CADS software integrates the patient's home blood glucose data with appropriate laboratory data (e.g. A1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses. The software makes a recommendation about what medication changes are appropriate with potential alternates. Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- Computer-Assisted Decision Support
- Keywords
- DM, T2DM, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted Decision SupportOther
The CADS software makes a recommendation about what medication changes are appropriate with potential alternates. CADS providers will either "accept" or "reject" the recommendation by the software.Providers with their patients are block randomized into CADS or "Usual Care" for 1 year. Patients associated with a CADS provider will upload their blood glucose data weekly and perform a 7-point glucose profile once per month. They will report major hypoglycemic events and hospitalizations at the time of their quarterly visit. Those getting "usual care" will be seen quarterly and will do self-monitoring of blood glucose and have A1c tests as determined by the provider but no less than twice a year.
| Study group | Role | What they receive |
|---|---|---|
| Computer-Assisted Decision Support | Experimental | These providers will use the CADS program to treat their enrolled patients. Receives: Other: Computer-Assisted Decision Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1c
Change is A1c will be measured 5 times over the course of the study to compare the patients for whom the provider is using CADS to those patients whose providers are delivering "usual care".
Measured: baseline, 12, 24, 36, and 48 months
Secondary outcomes (10)
Major events
The number of major ("severe") hypoglycemic events whether subjective (undocumented) or objective (SMBG or other confirmation, need for intervention, seizure, coma), and emergency room visits for DM-related causes.
Measured: ongoing
Other DM-related events
Number of ER visits for DM-related causes, DM-related hospitalizations and hospital days, and DM-related clinic visits.
Measured: ongoing
Glucose measures
Mean pre-prandial glucose, mean post-prandial glucose, post-prandial glucose excursions
Measured: baseline, 12, 24, 36, 48 months
Blood pressure
Clinically significant or statistically detectable changes in BP
Measured: baseline, 12, 24, 36, and 48 months
Lipids
Clinically significant or statistically detectable changes in lipid profile.
Measured: baseline, 12, 24, 36, and 48 months
Patient satisfaction with treatment
Clinically significant or statistically detectable changes in satisfaction with treatment as measured by the DTSQ.
Measured: basline and 48 months
Quality of life
Clinically significant or statistically detectable changes in quality of life for patients with DM as measured by the SF-8.
Measured: baseline and 48 months
Degree of Acceptance
The degree of acceptance of CADS by PCPs as measured by a technical assessment questionnaire.
Measured: baseline and 48 months
Acceptance of uploading data
The degree of acceptance of uploading the glucose meters by patients as measured by a technical assessment questionnaire.
Measured: baseline, 12, 24, 36, and 48 months
Demographic variables
The relationship of the primary and/or secondary outcomes to the type of provider, board-certification or eligibility, years in practice, age and gender.
Measured: baseline and 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Walter Reed National Military Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Alicia L. Warnock, Walter Reed National Military Medical Center
- Investigators
- Robert A Vigersky, M.D., Principal investigator, Walter Reed National Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648244
- Sponsor's protocol ID
- 353757
- Acronym
- CADS
- Status last verified
- Nov 2015
- First submitted
- 17 Jul 2012
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Computer Assisted Diabetes Decision Support (CADS) System to Improve Outcomes in Patients With Type 2 Diabetes Who Are Treated by Primary Care Providers
- ClinicalTrials.gov ID
- NCT01648244
- Acronym / sponsor ID
- CADS / 353757
- Conditions
- Type II Diabetes Mellitus
- Keywords
- DM, T2DM, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Walter Reed National Military Medical CenterUS federal agency
- Study start
- Mar 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 24 Jul 2012 (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 CADS by primary care providers (PCPs) for their patients with type 2 diabetes (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
The CADS software integrates the patient's home blood glucose data with appropriate laboratory data (e.g. A1c, liver function, kidney function), demographic data (age, gender), current and previous medications, and active/inactive medical diagnoses. The software makes a recommendation about what medication changes are appropriate with potential alternates. Providers with their patients are block randomized into CADS or "Usual Care" for 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computer-Assisted Decision Support | Experimental | Other: Computer-Assisted Decision SupportThese providers will use the CADS program to treat their enrolled patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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 in Section 6.3.2 of the protocol.
Key exclusion criteria (5 listed)
- 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 in Section 6.3.2 of the protocol.
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 SupportThe CADS software makes a recommendation about what medication changes are appropriate with potential alternates. CADS providers will either "accept" or "reject" the recommendation by the software.Providers with their patients are block randomized into CADS or "Usual Care" for 1 year. Patients associated with a CADS provider will upload their blood glucose data weekly and perform a 7-point glucose profile once per month. They will report major hypoglycemic events and hospitalizations at the time of their quarterly visit. Those getting "usual care" will be seen quarterly and will do self-monitoring of blood glucose and have A1c tests as determined by the provider but no less than twice a year. | Other | Computer-Assisted Decision Support |
Primary outcome
Change in A1c
Time frame: baseline, 12, 24, 36, and 48 months
Change is A1c will be measured 5 times over the course of the study to compare the patients for whom the provider is using CADS to those patients whose providers are delivering "usual care".
10 secondary outcomes
Major events
Time frame: ongoing
Other DM-related events
Time frame: ongoing
Glucose measures
Time frame: baseline, 12, 24, 36, 48 months
Blood pressure
Time frame: baseline, 12, 24, 36, and 48 months
Lipids
Time frame: baseline, 12, 24, 36, and 48 months
Patient satisfaction with treatment
Time frame: basline and 48 months
Quality of life
Time frame: baseline and 48 months
Degree of Acceptance
Time frame: baseline and 48 months
Acceptance of uploading data
Time frame: baseline, 12, 24, 36, and 48 months
Demographic variables
Time frame: baseline and 48 months
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 25 Nov 2015.
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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.
Robert A Vigersky, M.D. principal investigator
Walter Reed National Military Medical Center
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 Type II Diabetes Mellitus, run by Walter Reed National Military 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 4 inclusion and 5 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 25 Nov 2015. 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?
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?
Change in A1c (time frame: baseline, 12, 24, 36, and 48 months). 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 25 Nov 2015.