Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App

StatusRecruiting
PhaseNot applicable
SponsorFIDAM RDC
Started

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Record History

  1. Study First Submitted
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The goal of this controlled pre-post-trial is to test the Accu-Chek SmartGuide continuous glucose monitoring (CGM) system and whether its predictive features provide additional benefits for adults with type 1 diabetes or insulin- treated type 2 diabetes. The main questions this study aims to answer are: * Does using the Accu-Chek SmartGuide together with the Predict App change participants' fear of hypoglycemia? * Does the Predict App affect other psychological and behavioral outcomes, such as sleep quality, confidence in preventing hypoglycemia, diabetes- related distress, and diabetes empowerment? * Does the use of the predictive features affect glucose levels and the way participants use and respond to CGM alarms and trend information? Participants will use the Accu-Chek SmartGuide for 6 weeks. During the first 2 weeks, participants will use the CGM system without the predictive features. During the following 4 weeks, participants will use the system together with the Accu-Chek SmartGuide Predict App. Participants will complete online questionnaires at two time points (after 2 and after 6 weeks) and answer short questions twice a day through a smartphone app during the first 2 weeks and the last 2 weeks of the study. CGM data will be collected throughout the study. A subgroup of 10 participants will also be invited to take part in an online interview about their experiences with the predictive features.
Trial Details
NCT Number NCT07814508
Lead Sponsor FIDAM RDC
Collaborators: Roche Diabetes Care
Conditions
(from sponsor)
Diabetes (DM), Diabetes Mellitus, Diabetes Mellitus Type 2, Diabetes Mellitus Type 1, Diabetes Mellitus ( Type 1 and Type 2), Fear of Hypoglycemia, Sleep Quality, Diabetes Distress +6 more
Related terms Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders
Enrollment 89 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov