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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Obesity

Intervention / Treatment
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* Behavioral: Mobile and connected health


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes Overweight or obese with an BMI > 25 Able to read and write English Own a smart phone that is Jawbone compatible Exclusion Criteria: 1. Currently undergoing current treatment for a severe psychiatric disorder.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Connected group<br>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. | Behavioral: Mobile and connected health<br>* 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.<br>|
| No Intervention: Usual diabetes education and care<br>Participants will receive standard diabetes education and care; each of the recruiting clinics offers diabetes self-management education programs. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c levels from baseline to 3 months | 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. | baseline and 3 months post enrollment | 
| Change in weight measures from baseline to 3 months | Participant weight will be measured via a weight scale or via self-report. | baseline and 3 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usability of the connected interface technology as indicated by a System Usability Scale | 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. | 3 months post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Diabetes Mellitus, Type 2, obesity, self-monitoring, goal setting, mobile health, connected health