Diabetes Mellitus, Type 2, Obesity
Conditions
Keywords
Diabetes, Diabetes Mellitus, Type 2, obesity, self-monitoring, goal setting, mobile health, connected health
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.
Interventions
BEHAVIORALMobile 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.
Sponsors
University of Pittsburgh
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed