N/A
N=600
Diabetes Outcomes and Unmet Resources
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03950973 ↗Enrolled (actual)
600
Serious AEs
41.3%
Results posted
May 2024
Primary outcome: Primary: Change in HbA1c as Measured by an HbA1c Machine — 0.07; -0.10 percentage of average glucose 3 months
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CareAvenue (Behavioral); Guest Assistance Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1c as Measured by an HbA1c Machine |
0.07; -0.10 | — |
| SECONDARY Change in Systolic Blood Pressure as Measured an Automated Blood Pressure Machine |
-4.00; -6.00 | — |
| SECONDARY Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Diabetes as Measured by Participant Questionnaire |
-0.45; -0.91 | — |
| SECONDARY Change in Cost-Related Non-Adherence Behaviors With Prescribed Treatment Regimens Related to Other Conditions Being Managed as Measured by Participant Questionnaire |
-0.07; -0.06 | — |
| SECONDARY Change in Perceived Financial Burden as Measured by the Comprehensive Score for Financial Toxicity (COST) - Functional Assessment of Chronic Illness Therapy (FACIT) |
2.01; 2.74 | — |
| SECONDARY Change in Unmet Social Risk Factors as Measured by 20 Items in Participant Questionnaire |
-1.05; -1.48 | — |
| SECONDARY Change in Unmet Social Risk Factors as Measured by Participant Questionnaire |
-0.26; -0.27 | — |
Summary
This study will refine and test the effectiveness of CareAvenue, an automated e-health tool that informs and activates patients with uncontrolled diabetes to take steps in accessing resources and engaging in self-care. Our central hypothesis is that activating patients with uncontrolled diabetes and linking them to resources to address financial burden and unmet social risk factors will improve both intermediate outcomes and measures of disease control above and beyond existing services, especially for high need patients.
Eligibility Criteria
Inclusion Criteria
- Be 18-75 years of age
- Be diagnosed with type 1 or type 2 diabetes with prescribed anti-hyperglycemic medication
- Have a most recent hemoglobin A1c(HbA1c) level within the past 6 months of ≥7.5% for individuals ≤70 years and >8.0% for individuals between 70-75 years in age
- Have access to a telephone that can receive and send text messages
- Not participating in another diabetes intervention research study
Exclusion Criteria
- Significant cognitive impairment precluding individuals from completing the study as evidenced by ability to complete study intake procedures.
Data sourced from ClinicalTrials.gov (NCT03950973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.