CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 182 enrolled
Drug / intervention
DM Pgm + device +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01975428
NCT01975428N/ACompleted

Scripps Wired for Health Monitoring Study

Scripps Translational Science Institute·interventional·Posted Nov 4, 2013·Updated Apr 21, 2023

In Brief

A clinical study evaluating DM Pgm + device and Control for Diabetes and 2 related conditions. Completed, enrolled 182 participants across 1 site.

Detailed Summary

People with chronic diseases such as diabetes, hypertension (high blood pressure) and cardiac (heart) arrhythmias tend to go to the doctor more often and have more tests done than those without those diseases. This can lead to increasing costs of healthcare and extra visits to doctors and healthcare facilities. There are now medical devices that can be used at home to monitor blood sugar, blood pressure, heart rhythms as well as other measurements. There have been some studies which show that when people take their own health readings, they are better able to control their disease, stay healthier and go to the doctor less often. In order to participate in the study participants will have been diagnosed with 1 or more of the following: Diabetes, Hypertension, Cardiac Arrhythmias. This study is designed to test those devices and see if they can help participants stay healthier through the recording and tracking of health measurements. Investigators will also be testing how easy it is to use these devices and whether or how easy it is to fit them in their daily schedule. Participants will be given an iPhone for use during the study and their recordings will be stored and displayed on the phone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsScripps Health

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 4, 2013
Enrollment StartNov 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.7 years ago

Interventions

DM Pgm + devicedevice

Disease management program plus a device corresponding to an individual's disease(s): iBGStar - iPhone enabled capillary blood glucose meter. Subjects test blood glucose up to 4 times per day, every day. Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week. iPhone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic.

Controlbehavioral

All study participants, including participants randomized to the control arm, were enrolled in the HealthComp disease management program, which involved outreach by HealthComp nursing staff for purposes of relaying medical education and wellness information with regard to disease prevention and chronic disease management.