Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App
Changes in Person-reported Outcomes and Behavior Due to a Predictive Algorithm: A Pre-post Trial With the Accu-Chek SmartGuide CGM and the Predict App Solution
FIDAM RDC
89 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
SmartGuide CGM without Predict App Accu-Check SmartGuide CGM solution will be tested without the prediction function
SmartGuide CGM + Predict App Accu-Check SmartGuide CGM solution will be tested with the added benefit of the prediction function
Locations(1)
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NCT07814508