Role of Mobile Technology to Improve Diabetes Care in Adults With Type 1 Diabetes: the REMOTE-T1D Study, a Pilot Study
Completed · Phase 4
Conditions studied: Type 1 Diabetes
In brief
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 questionnaire. In the future, this study might lead to investigating the role of social media with mobile phones in Type 1 Diabetes (T1D) care. Moreover, the number of patients with T1D continues to increase, and such technology could conceivably help compensate for the shortages of endocrinologists providing care.
Key facts
- Study ID
- NCT01825382
- Run by
- University of Colorado, Denver
- People needed
- 100
- Starts
- 2012-12-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2014-05-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Barbara Davis Center — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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