Type 1 Diabetes Clinical Trial
Official title:
Role of Mobile Technology to Improve Diabetes Care in Adults With Type 1 Diabetes: the REMOTE-T1D Study, a Pilot Study
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.
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 (REMOTE-T1D). We hypothesize that the use of mobile technology (iBGStar®
technology [iPhone® plus the BGStar®]) will result in improvement in Patient Reported
Outcomes (PRO), and Treatment Satisfactions with a possible reductions of glucose
excursions, A1c, and severe hypoglycemia as compared to routine clinical care using
traditional glucose meter SMBG-Accu-chek®. This study aims to demonstrate the efficacy of
these technologies in a clinical setting with a hope to improve outcomes and health care
cost savings.
The study will enroll 100 patients from the Barbara Davis Center Adult clinic over the age
of 18 years who will be randomized in a 1:1 fashion to intervention group using mobile
technology (iBG Star) vs. continued routine clinical care (control) using SMBG-Accu-chek
meter. All subjects will be followed for study visits with similar frequency at baseline,
1-week, 1-month, 3-months, and 6-months and wear a continuous glucose monitor (CGM) using a
DexCom SEVEN Plus® system in a blinded mode for 7 days at baseline (wk0), 1mo, 3mo, and 6mo.
Laboratory analysis for A1c will be performed at baseline, 1-month 3-months, and 6-months.
Routine blood tests will be performed in all subjects at baseline, 3months, and 6-months.
Blinded CGM data will be analyzed for mean blood glucose values, time spent in hyperglycemic
(>240, >300mg/dl) and hypoglycemic (<50, <70, <80 mg/dl) ranges and various indices of
glycemic variability.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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