Connecting Smartphones With Electronic Health Record to Facilitate Behavioral Goal Monitoring in Diabetes Care

Early Phase 1

Completed

• Conditions: Obesity; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Mobile and connected health

• Registration Number: NCT02664233
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

In order to facilitate the evidence-based goal setting and self-monitoring intervention into the diabetes education practice, the investigator proposes to use Chronicle Diabetes, an electronic system provided available to the American Diabetes Association diabetes education programs, to set patient diet and physical activity goals, and connect patient self-monitoring information collected from smart phones and fitness trackers to Chronicle Diabetes system to facilitate educators' monitoring of patient adherence to their goals.

Detailed Description

Specific Aim 1: To develop and test an interface with Chronicle Diabetes to transfer smartphone collected self-monitoring diet and physical activity information from patients to diabetes educators.

Specific Aim 2: To 2a) conduct usability testing and 2b) examine efficacy of this connected interface technology in a 3-month randomized clinical trial in 60 overweight or obese patients with type 2 diabetes in Houston, Texas and Pittsburgh, Pennsylvania.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-29
• Last Update Posted: 2016-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Diagnosed with type 2 diabetes
2. Overweight or obese with an BMI > 25
3. Able to read and write English
4. Own a smart phone that is Jawbone compatible

Exclusion Criteria

1. Currently undergoing current treatment for a severe psychiatric disorder.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Connected group	Mobile and connected health	Patients will use a smart phone and a fitness tracker for self-monitoring of diet and physical activity for 3 months; 3) Smart phones will provide feedback with graphical presentation of self-monitored information to patients; 4) Patient self-monitored information will be integrated into Chronicle Diabetes, so that educators will be able to view this information and give feedback in a follow-up visit.

Primary Outcome Measures

Name	Time	Method
Change in weight measures from baseline to 3 months	baseline and 3 months post enrollment	Participant weight will be measured via a weight scale or via self-report.
Change in HbA1c levels from baseline to 3 months	baseline and 3 months post enrollment	Glycemic control will be determined by HbA1c level. HbA1c will be measured using the A1c NOW self check system via a finger stick or extracted from clinical visit data.

Secondary Outcome Measures

Name	Time	Method
Usability of the connected interface technology as indicated by a System Usability Scale	3 months post enrollment	The System Usability Scale measures patients' and educators' acceptability, satisfaction, and perceived usefulness of the intervention that is the focus of this study (that is, the connected interface technology within Chronicle Diabetes--Chronicle Diabetes is an electronic diabetes education documentation system to transfer smartphone and wristband collected self-monitoring diet and physical activity information from patients to diabetes educators). Patients and educators are asked to rate each usability item in the scale from 0 to 100.

Trial Locations

Locations (2)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States