Family Diabetes Self-Management Education and Support for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Diabetes Mellitus, Type 2
Family Diabetes Self-Management Education and Support - Behavioral
Eligibility
18+
All Sexes
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Study Summary

This trial will compare the effectiveness of a diabetes education program that includes family members to a diabetes education program that does not include family members.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

Month 18
Change in mean BMI from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean HbA1c (NGSP%) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean blood glucose from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean blood pressure (systolic & diastolic, mmHg) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean high-density lipoproteins (HDL) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean low-density lipoproteins (LDL) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean triglycerides from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Change in mean waist circumference from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention medical record abstraction
Month 18
Change in mean total cholesterol (mg/dL) from baseline to immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention
Month 12
Change in diabetes self-efficacy from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Change in diabetes self-management behaviors from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Change in diabetes-related distress from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Change in diabetes-related quality of life from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention
Change in medication adherence from baseline to immediate post-intervention, 6 months post-intervention, and 12 months post-intervention

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard-DSME
1 of 2
Family-DSME
1 of 2
Active Control
Experimental Treatment

1200 Total Participants · 2 Treatment Groups

Primary Treatment: Family Diabetes Self-Management Education and Support · No Placebo Group · N/A

Family-DSME
Behavioral
Experimental Group · 1 Intervention: Family Diabetes Self-Management Education and Support · Intervention Types: Behavioral
Standard-DSME
Behavioral
ActiveComparator Group · 1 Intervention: Standard Diabetes Self-Management Education and Support · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, and 18 months post-intervention

Who is running the clinical trial?

University of ArkansasLead Sponsor
459 Previous Clinical Trials
145,310 Total Patients Enrolled
11 Trials studying Diabetes Mellitus, Type 2
1,578 Patients Enrolled for Diabetes Mellitus, Type 2
Patient-Centered Outcomes Research InstituteOTHER
492 Previous Clinical Trials
29,826,475 Total Patients Enrolled
16 Trials studying Diabetes Mellitus, Type 2
2,153,435 Patients Enrolled for Diabetes Mellitus, Type 2
Pearl McElfish, PhDPrincipal InvestigatorUAMS
2 Previous Clinical Trials
668 Total Patients Enrolled
2 Trials studying Diabetes Mellitus, Type 2
668 Patients Enrolled for Diabetes Mellitus, Type 2

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: October 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.