PreDiabetesPreDM_CDSNCT04335331
PreDM Clinical Decision Support Intervention
An observational study of PreDiabetes, run by Northwestern University at 1 site in United States.
Trial summary
Clinical practice guidelines recommend intensive lifestyle interventions and metformin to prevent or delay type 2 diabetes; yet these treatments are not routinely used among the 86 million U.S. adults with prediabetes who may benefit from them. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- How many people
- 7,424 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2020to 2 Sep 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who receive primary care at participating clinics and who meet the study eligibility criteria based on automated searches of the electronic health record systems will be eligible to participate.
Who may be able to join
- age ≥18 years old
- prediabetes
- two weight measurements during the study period
Who cannot join
- The primary exclusion criterion is type 2 diabetes.
- The following additional criteria will exclude those in whom treatment is potentially harmful or outcomes assessment may be confounded: serum creatinine >1.4mg/dL in women and >1.5mg/dL in men, uncontrolled hypertension (≥180/100mmHg), prior antidiabetic medication orders, and gastric bypass surgery or pregnancy during the evaluation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevent Diabetes Mellitus PreDM Clinical Decision Support Intervention in Community Health Centers
Clinical practice guidelines recommend intensive lifestyle interventions and metformin to prevent or delay type 2 diabetes; yet these treatments are not routinely used among the 86 million U.S. adults with prediabetes who may benefit from them. While clinical decision support (CDS) represents an effective approach for delivering guideline-based care, the potential of this strategy to improve diabetes prevention efforts has not been definitively tested. This study developed the novel Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention and evaluated its impact on clinical outcomes.
Read the detailed description
Eighty six million U.S. adults have prediabetes, and up to 75% of them will eventually develop diabetes. Landmark clinical trials have established that intensive lifestyle interventions (ILI) and metformin are safe and effective treatments to prevent or delay diabetes in adults with prediabetes and overweight/obesity. Despite being included in expert clinical guidelines, these treatments are rarely used and few studies have explored how to promote their uptake in practice. One possible approach for increasing adoption of ILI and metformin in primary care includes clinical decision support (CDS), which uses electronic systems to create tailored recommendations for evidence-based clinical care. While a large body of evidence demonstrates that CDS can improve the delivery of other recommended preventive services, this approach has not been definitively studied for ILI and metformin. The investigators plan to address this critical knowledge gap by developing and evaluating the Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention for community health center patients with prediabetes and overweight/obesity. This novel CDS engages primary care providers and clinical staff to deliver intervention components.
This study tests the potential for CDS to promote diabetes prevention and weight loss efforts in primary care. The current study objectives were to: 1) interview providers about their preferences for CDS focused on prediabetes; 2) develop a novel CDS tool, the Prediabetes CDS (PreDM CDS), promoting evidence-based care for prediabetes; and 3) conduct a pilot evaluation of the novel CDS tool using electronic health record data. Study investigators hypothesize that the proposed PreDM CDS will increase patient's adoption of ILI and metformin, producing modest weight loss and improvements in other cardiometabolic markers.
- Conditions
- PreDiabetes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PreDM CDS | The PreDM CDS is a passive electronic health record button that appears automatically under the Assessment/ Plan only for patients with prediabetes. When clinicians choose to click on this button, the PreDM CDS displays the last three measurements of weight, body mass index (BMI), hemoglobin A1c (HbA1c), fasting glucose, random glucose, and creatinine. This tool included order options enabling prediabetes management in a single location within the electronic health record. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A1c order
Mean differences in rates of hemoglobin A1c orders between treatment arms evaluated using mixed models adjusted for clinic site, time between visits, sex, age, race/ethnicity, and baseline cardiometabolic markers.
Measured: 18 Months
Secondary outcomes (1)
Weight
Mean between group differences in weight (lbs) evaluated using mixed models adjusted for clinic site, time between visits, sex, age, race/ethnicity, and baseline cardiometabolic markers.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start27 Feb 2020
- Primary completion1 Aug 2021
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7,424 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- AllianceChicago, Erie Family Health Centers
- Responsible party
- Principal investigator, Matthew J O'Brien, Northwestern University
- Investigators
- Matthew O'Brien, MD, MSc, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335331
- Sponsor's protocol ID
- STU00209789
- Acronym
- PreDM_CDS
- Status last verified
- Feb 2023
- First submitted
- 31 Mar 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevent Diabetes Mellitus PreDM Clinical Decision Support Intervention in Community Health Centers
- ClinicalTrials.gov ID
- NCT04335331
- Acronym / sponsor ID
- PreDM_CDS / STU00209789
- Conditions
- PreDiabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,424 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- AllianceChicago, Erie Family Health Centers
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 6 Apr 2020 (actual)
- 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.
Clinical practice guidelines recommend intensive lifestyle interventions and metformin to prevent or delay type 2 diabetes; yet these treatments are not routinely used among the 86 million U.S. adults with prediabetes who may benefit from them. While clinical decision support (CDS) represents an effective approach for delivering guideline-based care, the potential of this strategy to improve diabetes prevention efforts has not been definitively tested. This study developed the novel Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention and evaluated its impact on clinical outcomes.
Detailed description
Eighty six million U.S. adults have prediabetes, and up to 75% of them will eventually develop diabetes. Landmark clinical trials have established that intensive lifestyle interventions (ILI) and metformin are safe and effective treatments to prevent or delay diabetes in adults with prediabetes and overweight/obesity. Despite being included in expert clinical guidelines, these treatments are rarely used and few studies have explored how to promote their uptake in practice. One possible approach for increasing adoption of ILI and metformin in primary care includes clinical decision support (CDS), which uses electronic systems to create tailored recommendations for evidence-based clinical care. While a large body of evidence demonstrates that CDS can improve the delivery of other recommended preventive services, this approach has not been definitively studied for ILI and metformin. The investigators plan to address this critical knowledge gap by developing and evaluating the Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention for community health center patients with prediabetes and overweight/obesity. This novel CDS engages primary care providers and clinical staff to deliver intervention components.
This study tests the potential for CDS to promote diabetes prevention and weight loss efforts in primary care. The current study objectives were to: 1) interview providers about their preferences for CDS focused on prediabetes; 2) develop a novel CDS tool, the Prediabetes CDS (PreDM CDS), promoting evidence-based care for prediabetes; and 3) conduct a pilot evaluation of the novel CDS tool using electronic health record data. Study investigators hypothesize that the proposed PreDM CDS will increase patient's adoption of ILI and metformin, producing modest weight loss and improvements in other cardiometabolic markers.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PreDM CDS | – | –The PreDM CDS is a passive electronic health record button that appears automatically under the Assessment/ Plan only for patients with prediabetes. When clinicians choose to click on this button, the PreDM CDS displays the last three measurements of weight, body mass index (BMI), hemoglobin A1c (HbA1c), fasting glucose, random glucose, and creatinine. This tool included order options enabling prediabetes management in a single location within the electronic health record. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who receive primary care at participating clinics and who meet the study eligibility criteria based on automated searches of the electronic health record systems will be eligible to participate.
Key inclusion criteria (3 listed)
- age ≥18 years old
- prediabetes
- two weight measurements during the study period
Key exclusion criteria (2 listed)
- The primary exclusion criterion is type 2 diabetes.
- The following additional criteria will exclude those in whom treatment is potentially harmful or outcomes assessment may be confounded: serum creatinine >1.4mg/dL in women and >1.5mg/dL in men, uncontrolled hypertension (≥180/100mmHg), prior antidiabetic medication orders, and gastric bypass surgery or pregnancy during the evaluation period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A1c order
Time frame: 18 Months
Mean differences in rates of hemoglobin A1c orders between treatment arms evaluated using mixed models adjusted for clinic site, time between visits, sex, age, race/ethnicity, and baseline cardiometabolic markers.
1 secondary outcome
Weight
Time frame: 18 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 8 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Matthew O'Brien, MD, MSc principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes, run by Northwestern University 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 3 inclusion and 2 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 8 Feb 2023. 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?
A1c order (time frame: 18 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 8 Feb 2023.