RecruitingNot ApplicableNCT07814508

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


Sponsor

FIDAM RDC

Enrollment

89 participants

Start Date

Feb 1, 2026

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called SmartGuide CGM with Predict App and a medical device called SmartGuide CGM without Predict App for people with continuous glucose monitoring system, diabetes (dm), and other related conditions. The study is currently recruiting participants at 1 location.

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

DEVICESmartGuide CGM without Predict App

SmartGuide CGM without Predict App Accu-Check SmartGuide CGM solution will be tested without the prediction function

DEVICESmartGuide CGM with Predict App

SmartGuide CGM + Predict App Accu-Check SmartGuide CGM solution will be tested with the added benefit of the prediction function


Locations(1)

Fidam Rdc

Bad Mergentheim, Baden-Wurttemberg, Germany

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NCT07814508


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