Diabetes Mellitus, Type 2NCT04862858

Educational Intervention to Increase Select Guideline-recommended Cardioprotective Medications in Patients With Diabetes

A study testing Educational Intervention in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Humana Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is an educational outreach to patients with type 2 diabetes mellitus (T2DM) and atherosclerotic cardiovascular disease (ASCVD) and their primary care and specialist providers to improve use of guideline-recommended treatments, specifically sodium-glucose cotransporter 2 inhibitor (SGLT2i) and glucagon-like… Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Diabetes Mellitus, Type 2, Cardiovascular Diseases
What is being tested?: Educational Intervention
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4,197 participants
Where: 1 siteUnited States
Study dates: 18 Aug 2021to 16 Aug 2022
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

Patient
Patients with T2DM defined as ≥2 outpatient diagnoses of T2DM in any position on separate days; OR ≥1 inpatient diagnosis T2DM in any position; OR ≥1 outpatient diagnosis in any position AND ≥1 medication claim for T2DM
≥1 diagnosis code for ASCVD (coronary artery disease diagnoses or procedures, cerebrovascular disease, peripheral artery disease of atherosclerotic origin) on any claim type in any position within the 24-month period prior to identification
Enrolled in a Humana Medicare Advantage Prescription Drug plan with ≥12 months pre-identification continuous enrollment (no more than a 31 day gap) as of the identification date and currently enrolled as of the identification date
Age 18-85 years at time of identification
Patients residing in Kentucky (KY), West Virginia (WV), Pennsylvania (PA), and 6 counties in south New Jersey (NJ) (Burlington, Camden, Cumberland, Gloucester, Mercer, Salem) (United States)
Provider
Primary care providers of the identified patients

Who cannot join

Patients
≥1 diagnosis or procedure code for end-stage kidney disease, renal transplant, dialysis or kidney failure
Any hospice or long-term care residence
≥1 code for pregnancy/childbirth
Patients with any use of SGLT2i or GLP-1 RA medications in the pre-identification period
Patients without an attributed primary care provider

Show all 13Show fewer

Patients on do not contact lists
Patients without valid addresses and telephone numbers
Patients with ≥1 diagnosis for type 1 diabetes pre-identification
Primary care providers
Providers on do not contact lists
Providers without valid fax/mailing address and phone number
Providers with <3 or >50 eligible patients

Trial locations and contacts

1 site in 1 country.

United States1 site

Humana
Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: Improving Outcomes in Patients With Comorbid T2DM and ASCVD: Population Health Management Interventions Supporting Guideline-recommended SGLT2i and GLP-1 RA Medications

Read the detailed description

Patients with type 2 diabetes mellitus, a history of atherosclerotic cardiovascular disease, without use of select guideline-recommended medications in the previous year will be identified from administrative claims. Primary care providers will be identified, randomly selected and randomized to the intervention arm or control arm. All eligible patients for that provider will be included. The patient's specialist providers (cardiologist and/or endocrinologist, as applicable) will be identified and contacted. The intervention will include a multi-faceted strategy to support providers in the care of their patients by sharing recent guideline-based treatment recommendations and provide patients with information regarding ways to reduce their cardiovascular risk. Outreach will occur for all patients and providers randomized for the intervention - there will be no active enrollment or recruitment.

Conditions: Diabetes Mellitus, Type 2, Cardiovascular Diseases
Being tested: Educational Intervention
Medical subject headings: Diabetes Mellitus, Type 2, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Educational InterventionOther
The educational intervention will involve guideline-based treatment recommendation information for providers via fax/mail and phone and provide resources via mail and phone for patients to learn more about ways to reduce their cardiovascular risk.

Study groups in NCT04862858
Study group	Role	What they receive
Intervention	Active comparator	The educational outreach intervention will entail a multi-faced strategy to provide patients resources to learn more about reducing their risk for heart disease and supporting providers in the care of their patients by sharing recent guideline-recommended treatments for these high-risk individuals. Receives: Other: Educational Intervention
Control	No intervention	Patients and primary care providers randomly selected and assigned to the control arm will not receive any of the educational outreach communications.

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Percentage of individuals with T2D \& ASCVD who have ≥1 pharmacy claim for SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products
Measured: 6-months

Secondary outcomes (5)

Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Percentage of individuals with T2D \& ASCVD who have ≥1 pharmacy claim for SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products
Measured: 12-months
Percentage of individuals adherent to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Adherence to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, measured by proportion of days covered based on days' supply of medications from pharmacy claims
Measured: 6-months
Percentage of individuals persistent to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Persistence to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, measured by <90 day gap in treatment based on pharmacy claims
Measured: 6-months
Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products, based on administrative claims data
Percentage of individuals with T2D \& ASCVD who have ≥1 pharmacy claim for SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products
Measured: 6-months
Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products, based on administrative claims data
Percentage of individuals with T2D \& ASCVD who have ≥1 pharmacy claim for SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products
Measured: 12-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Aug 202116 Aug 2022

First posted28 Apr 2021
Study start18 Aug 2021
Primary completion30 Nov 2021
Study completion16 Aug 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, 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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 4,197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04862858
Sponsor's protocol ID: 1236
Status last verified: May 2022
First submitted: 12 Apr 2021
Last updated: 20 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S111-S124. doi: 10.2337/dc21-S009.
PubMed 33298420
American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S125-S150. doi: 10.2337/dc21-S010.
PubMed 33298421
Das SR, Everett BM, Birtcher KK, Brown JM, Januzzi JL Jr, Kalyani RR, Kosiborod M, Magwire M, Morris PB, Neumiller JJ, Sperling LS. 2020 Expert Consensus Decision Pathway on Novel Therapies for Cardiovascular Risk Reduction in Patients With Type 2 Diabetes: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2020 Sep 1;76(9):1117-1145. doi: 10.1016/j.jacc.2020.05.037. Epub 2020 Aug 5. No abstract available.
PubMed 32771263

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Outcomes in Patients With Comorbid T2DM and ASCVD: Population Health Management Interventions Supporting Guideline-recommended SGLT2i and GLP-1 RA Medications
ClinicalTrials.gov ID: NCT04862858
Acronym / sponsor ID: 1236
Conditions: Diabetes Mellitus, Type 2, Cardiovascular Diseases
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 4,197 participants (actual)
Lead sponsor: Humana Inc.Industry (pharma, biotech, devices)
Collaborators: Boehringer Ingelheim, Humana Healthcare Research, Inc.
Study start: 18 Aug 2021 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 16 Aug 2022 (estimated)
First posted: 28 Apr 2021 (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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intervention	Active comparator	Other: Educational InterventionThe educational outreach intervention will entail a multi-faced strategy to provide patients resources to learn more about reducing their risk for heart disease and supporting providers in the care of their patients by sharing recent guideline-recommended treatments for these high-risk individuals.
Control	No intervention	–Patients and primary care providers randomly selected and assigned to the control arm will not receive any of the educational outreach communications.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Patient
Patients with T2DM defined as ≥2 outpatient diagnoses of T2DM in any position on separate days; OR ≥1 inpatient diagnosis T2DM in any position; OR ≥1 outpatient diagnosis in any position AND ≥1 medication claim for T2DM
≥1 diagnosis code for ASCVD (coronary artery disease diagnoses or procedures, cerebrovascular disease, peripheral artery disease of atherosclerotic origin) on any claim type in any position within the 24-month period prior to identification
Enrolled in a Humana Medicare Advantage Prescription Drug plan with ≥12 months pre-identification continuous enrollment (no more than a 31 day gap) as of the identification date and currently enrolled as of the identification date
Age 18-85 years at time of identification

Key exclusion criteria (13 listed)

Patients
≥1 diagnosis or procedure code for end-stage kidney disease, renal transplant, dialysis or kidney failure
Any hospice or long-term care residence
≥1 code for pregnancy/childbirth
Patients with any use of SGLT2i or GLP-1 RA medications in the pre-identification period

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
Educational InterventionThe educational intervention will involve guideline-based treatment recommendation information for providers via fax/mail and phone and provide resources via mail and phone for patients to learn more about ways to reduce their cardiovascular risk.	Other	Intervention

Primary outcome

Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Time frame: 6-months
Percentage of individuals with T2D \& ASCVD who have ≥1 pharmacy claim for SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products

5 secondary outcomes

Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Time frame: 12-months
Percentage of individuals adherent to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Time frame: 6-months
Percentage of individuals persistent to guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data
Time frame: 6-months
Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products, based on administrative claims data
Time frame: 6-months
Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, including combination products, based on administrative claims data
Time frame: 12-months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
Background: PubMed 33298420American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S111-S124. doi: 10.2337/dc21-S009.
Background: PubMed 33298421American Diabetes Association. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S125-S150. doi: 10.2337/dc21-S010.
Background: PubMed 32771263Das SR, Everett BM, Birtcher KK, Brown JM, Januzzi JL Jr, Kalyani RR, Kosiborod M, Magwire M, Morris PB, Neumiller JJ, Sperling LS. 2020 Expert Consensus Decision Pathway on Novel Therapies for Cardiovascular Risk Reduction in Patients With Type 2 Diabetes: A Report of the American College of Cardiology Solution Set Oversight Committee. J Am Coll Cardiol. 2020 Sep 1;76(9):1117-1145. doi: 10.1016/j.jacc.2020.05.037. Epub 2020 Aug 5. No abstract available.
Individual participant dataSharing planned: No

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
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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.

Alexjandro Daviano, DN, DrPH principal investigator

Humana Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Educational Intervention in people with Diabetes Mellitus, Type 2 and Cardiovascular Diseases, run by Humana Inc. 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 8 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: status not confirmed, as of the sponsor's last update on 20 May 2022. 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?

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?

Percentage of individuals who initiate guideline-based SGLT2i or GLP-1 RA medications with cardiovascular benefit, excluding combination products, based on administrative claims data (time frame: 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04862858, which also lists 3 linked publications.

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 20 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.