NCT02664233

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for early_phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

December 9, 2015

Last Update Submit

October 29, 2016

Conditions

Diabetes Mellitus, Type 2Obesity

Keywords

DiabetesDiabetes Mellitus, Type 2obesityself-monitoringgoal settingmobile healthconnected health

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Usability of the connected interface technology as indicated by a System Usability Scale

    3 months post enrollment

Study Arms (2)

Connected group

EXPERIMENTAL

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

Usual diabetes education and care

NO INTERVENTION

Participants will receive standard diabetes education and care; each of the recruiting clinics offers diabetes self-management education programs.

Interventions

Mobile and connected healthBEHAVIORAL

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.

Connected group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. Currently undergoing current treatment for a severe psychiatric disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Pittsburgh

Pittsburgh, Pennsylvania, 77030, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Wang J, Coleman DC, Kanter J, Ummer B, Siminerio L. Connecting Smartphone and Wearable Fitness Tracker Data with a Nationally Used Electronic Health Record System for Diabetes Education to Facilitate Behavioral Goal Monitoring in Diabetes Care: Protocol for a Pragmatic Multi-Site Randomized Trial. JMIR Res Protoc. 2018 Apr 2;7(4):e10009. doi: 10.2196/10009.

    PMID: 29610111DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jing Wang, PhD, MPH, RN

    The University of Texas Health Science Center at Houston, School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 9, 2015

First Posted

January 26, 2016

Study Start

June 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

US(2)