Mobile Application to Enhance Diabetic Care

NCT01983917 | Withdrawn

• 1 other identifier: 12-001117
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective study to evaluate whether or not an internet application to coordinate and record diabetes management by the 1. diabetic patient/family caregiver 2. diabetic medical care team and 3. ophthalmology vision care team will decrease vision loss and blindness due to diabetic retinopathy. The aims will be measured through health psychology instruments to assess the effect of the application on management, motivation to control their disease, and commitment to comply with treatment. We will also measure objective health outcomes including Blood Pressure, Blood lipids level, hemoglobin A1c level, and Visual Acuity.

Conditions

Diabetes Mellitus

Keywords

diabetes; mobile application; diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

• Change of diabetic retinopathy risk factors

  risk factors normalization by assessment of hemoglobin A1c percent, blood lipids level and blood pressure level as continuous variables.

  1 year

Secondary Outcomes (1)

• Motivation for adhering to treatment recommendations and follow-up

  every 4 months

Study Arms (1)

Use of the Diabetes Application

OTHER

Behavioral: Diabetes Mobile Application

Interventions

Diabetes Mobile Application BEHAVIORAL

Use of the Diabetes Application

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with diabetes mellitus and receiving care from either Jules Stein Eye Institute or the Gonda Diabetes Center at UCLA.
• Between 14 and 75 years if age at the time of enrollment.
• Internet access with Apple i-Phone, Apple i-Pad, and/or Apple i-Pod Touch on a weekly basis.
• English language and Internet capability for data entry, monitoring, and comprehension of reports.
• Able to attend Standard of Care visits for 1 to 3 years.
• Able to understand and willing to sign the informed consent perform and comply with all study procedures

You may not qualify if:

• Any social, mental or physical condition that impairs ability to give consent, maintain Internet access or attend physician visits.
• Prior or concurrent eye or vision condition that would interfere with participation in or interpretation of the study.
• Prior or concurrent disease or medical condition that is likely to compromise interpretation of the study.
• \. Inability or unwillingness of the patient's diabetes medical care or ophthalmology vision care team to participate.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Jules Stein Eye Institute

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 14, 2013
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

US (1)