Role of Mobile Technology to Improve Diabetes Care in Adults With Type 1 Diabetes: the REMOTE-T1D Study, a Pilot Study (REMOTE-T1D)
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|ClinicalTrials.gov Identifier: NCT01825382|
Recruitment Status : Completed
First Posted : April 5, 2013
Last Update Posted : May 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: iBGStar meter||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Role of Mobile Technology to Improve Diabetes Care in Adults With Type 1 Diabetes: the REMOTE-T1D Study, a Pilot Study|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||November 2013|
No Intervention: Accu-chek Meter
Patients receiving the Accu-chek nano meter for use during the study.
Experimental: iBGStar meter interventional Arm
Subjects are given iBGstar meter along with iPhone to use as interventional meter.
Device: iBGStar meter
Subjects will receive iBGStar meter and iPhone to use as meter during the study.
- Patient Reported Outcomes as it relates to hypoglycemia fear and quality of life. [ Time Frame: 6 months ]Primary outcome is patient related outcomes and changes based on the hypoglycemia fear questionnaire and changes in patient comfort in meter use.
- Improvement in glucose control and indices off glucose variability from SMBG and CGM data. [ Time Frame: 6 months ]Improvement in parameters of glycemic variability as measured by glucose excursions from SMBG and CGM downloads and various indices (J-index, mean amplitude of glycemic excursion (MAGE), high blood glucose index (HBGI), low blood glucose index (LBGI), from, CGM downloads. Reduction in A1c of 0.3% from screening to 3-months and maintained at 6-months, and reduction of hypoglycemia (measured or self reported). Cost analysis will be done based upon primary and secondary outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825382
|United States, Colorado|
|Barbara Davis Center|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Satish K Garg, MD||University of Colorado, Denver|