Recruiting

Diabetes Distress Screening

Sponsor:

University of Chicago

Code:

NCT06887049

Conditions

Type 2 Diabetes Mellitus (T2DM)

Diabetes Distress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ARISE Learning Community Diabetes Distress Screening and Intervention

ARISE Enhanced Care brief training

Study Details

Brief summary:

The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM).

Conditions

Type 2 Diabetes Mellitus (T2DM)

Diabetes Distress

Study ID

NCT06887049

Start date

Mar 10, 2026

Status verified date

Jun, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient at a participating clinic
  • Type 2 diabetes
  • Adult (18 years or older)
  • A1C > 8%

Exclusion Criteria:

  • Pregnant

Study Design

Enrollment

1250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: ARISE Learning Community Arm

Community Health Centers will be given an in-depth training on the ARISE screening and intervention algorithm

other: ARISE Enhanced Care

Community Health Centers will be given a brief training on the 7A's model of diabetes distress screening and intervention

Interventions

ARISE Learning Community Diabetes Distress Screening and Intervention

In-depth training for frontline community health center staff on ARISE algorithm to screen for degree of diabetes distress using T2-DDAS Core. If positive, screen for sources of diabetes distress using T2-DDAS Sources. Discuss results with patient and make any relevant referrals.

ARISE Enhanced Care brief training

Brief training on American Diabetes Association guidelines for screening for diabetes distress using the 7A's model

Primary outcome measure

  • Rate of A1C across time [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Abby Sr. Research Project Manager, MSW

773-834-5646abigail.durgan@bsd.uchicago.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Sr. Research Project Manager

773-834-5646abigail.durgan@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Jul 8, 2026

Last verified

Jun, 2026

Keywords

  • diabetes distress screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-07-08.