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

RecruitingNAAges 18 Years - anyAllFIDAM RDC
NCT07814508 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 fe

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📋 Eligibility rules (as published)
Inclusion Criteria: * Type 1 diabetes or Type 2 diabetes with intensified insulin therapy (defined as basal-bolus therapy with self-adjustment of bolus doses) * CGM use during the past 3 months (without predictive features) * Age ≥ 18 years * HbA1c \< 10% * Informed consent Exclusion Criteria: * Use of the SmartGuide CGM solution * AID use * Current treatment with psychiatric medications * Diabetes duration \< 3 months * Current or planned pregnancy * Peripheral neuropathy that will impact sleep quality according to the judgement of the participant * Severe complications (e.g. kidney disease, cancer)
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What it tests

  • SmartGuide CGM with Predictive Features
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Where

1 site
Fidam Rdc
Bad Mergentheim, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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