Testing New Models of Diabetes Self-Management to Improve Population Health

Texas A&M University

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Living Healthier with Diabetes

Study type: Interventional

Funder types: Other

Identifiers

NCT06370494

IRB2020-0956D

Details and patient eligibility

About

Aim 1.1 To understand if diabetes self-management education and support (DSMES) improves diabetes-related outcomes among those with Type 2 diabetes living in Texas.

Aim 1.2 To examine how rurality affects study participation, engagement in, and effectiveness of different education interventions.

These aims are based on a randomized controlled trial of different evidence-based diabetes self-management interventions.

Full description

A randomized controlled trial (RCT) was conducted to assess the outcomes associated with different technological intervention approaches. This 3-arm RCT assessed independent and combined interventions:

Enrollment: 191 patients

Sex: All

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus (T2DM) - self-reported diagnosis by a health care provider
• HbA1c value greater than or equal to 7.5%
• Adults ages 25 years and older
• All genders
• Have access to device (smartphone/tablet which meets iOS 13 or above or similar system requirements/iPhone 7 and above or Android 6 and above) and internet in order to view online diabetes education content
• Ability to read and speak English
• Resides in Texas

Exclusion criteria

• Pregnant women
• Participation in ADA-recognized or AADE-accredited diabetes self-management education program lasting at least eight hours within previous six months
• Engagement with ADA-recognized or AADE-accredited smartphone application with certified diabetes educators providing tracking and health coaching within the previous six months
• Those diagnosed with any conditions listed below (determined by self-report): Liver failure, End-stage renal disease (stage 4 or 5), Congestive heart failure (grade C or D), Organ transplant or bone marrow transplant, Cystic fibrosis, Malignant neoplasm or bone marrow transplant
• Criteria excludes individuals based on language. Participants must be able to read and speak English. Technology-based education and support (TBES) is available only in English.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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191 participants in 3 patient groups

Virtual Making Moves with Diabetes [MMWD] Group

Experimental group

Description:

Virtual asynchronous training and periodic one-on-one counseling with a clinical diabetes educator, either a Registered Nurse (RN) or Registered Dietitian Nutritionist (RDN). The program was recognized by the American Diabetes Association during this study. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, and 3 and 6-month follow-ups.

Treatment:

Behavioral: Living Healthier with Diabetes

App Group

Experimental group

Description:

Smartphone application for more continuous but less structured chat support. This app was recognized by the American Diabetes Association. The intervention included access to online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups.

Treatment:

Behavioral: Living Healthier with Diabetes

Combo Group

Experimental group

Description:

A combined approach for maximal support and reinforcement. The intervention included 8 hours of online diabetes education, 30 minute 1:1 virtual education and counseling with a diabetes educator, access to the app with online diabetes support tools and ability to message a diabetes specialist for support, and 3 and 6-month follow-ups.

Treatment:

Behavioral: Living Healthier with Diabetes