Status:
COMPLETED
Role of Mobile Technology to Improve Diabetes Care in Adults With Type 1 Diabetes: the REMOTE-T1D Study, a Pilot Study
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Sanofi
Colorado Prevention Center
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The goal of this prospective pilot study is to evaluate the use of remote technology (iBGStar in combination with Diabetes Manager App on iPhone) to patient related outcomes, and a hypoglycemia fear q...
Detailed Description
This is a single-center, prospective, randomized, 'open-label,' investigator initiated pilot study evaluating the role of mobile technology to improve diabetes care in adults with type 1 diabetes (REM...
Eligibility Criteria
Inclusion
- Subjects that meet the following criteria will be considered for admission to the study:
- Signed informed consent before any study-related activities
- Male or female aged 18 years and older T1D duration \>1 year
- A1c \<10%
- Willingness to routinely practice at least 3-7 blood glucose measurements per day
- Ability and willingness to adhere to the protocol including scheduled study visits and blinded CGM wear intermittently) for 6 months. During the weeks of blinded CGM wear, subjects will not be able to use their own real-time CGMs (if they own it)
- Able to speak, read and write English
Exclusion
- Subjects will be excluded from the study if any of the following apply:
- Pregnant or intention to become pregnant during the course of the study
- Severe unexplained hypoglycemia requiring emergency treatment in the previous 6 months
- Use of systemic or inhaled corticosteroids
- History of hemoglobinopathies
- Diagnosis of anemia
- History of pancreatitis
- Extensive skin changes/diseases that inhibit wearing a sensor on normal skin
- Known allergy to adhesives
- Current participation in another investigational study protocol. Must have completed a previous study at least 30 days prior to enrollment.
- Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent
- Subjects will not be allowed to use real-time CGM during the blinded CGM wear week.
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01825382
Start Date
December 1 2012
End Date
November 1 2013
Last Update
May 21 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Barbara Davis Center
Aurora, Colorado, United States, 80045