Diabetes Self-Management Education with Sleep Hygiene

University of Arkansas

Status: Withdrawn

Conditions: Diabetes Mellitus, Type 2; Sleep Hygiene

Treatments: Behavioral: Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)

Study type: Interventional

Funder types: Other

Identifiers

NCT04420845

239740

Details and patient eligibility

About

This study will test whether adding sleep hygiene education and support to diabetes self-management education and support (DSMES) in diverse patients (African American, Hispanic, Pacific Islander, and Caucasian) with type 2 diabetes myelitis (T2DM) from rural UAMS Regional Programs clinics is more effective than DSMES alone. The specific aims for this study are:

• Aim 1A (Primary): Determine if this model improves blood glucose levels as measured by the HbA1c test in diverse adults with T2DM.
• Aim 1B: Determine the preliminary effectiveness of DSMES+SHES on sleep duration and sleep quality, blood pressure, fasting lipids, body mass index (BMI), self-management behavior, self-efficacy, diabetes-related distress, and diabetes-related quality of life in diverse adults with T2DM.
• Aim 2A: Determine the feasibility and acceptability of DSMES+ SHES when implemented with diverse adults with T2DM.
• Aim 2B: Determine the feasibility and acceptability of DSMES+ SHES implementation in Regional Programs clinics.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Diagnosed with type 2 diabetes
• Speak English

Exclusion criteria

• Received DSME in the past three years
• Have a condition that makes it unlikely they will be able to follow the protocol

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

0 participants in 1 patient group

Intervention

Other group

Treatment:

Behavioral: Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)