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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: FIDAM RDC • ClinicalTrials.gov ID: NCT07814508

Registry updated: 2026-09-11
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Description

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.

Interventions

  • SmartGuide CGM without Predict App (Device)
    SmartGuide CGM without Predict App Accu-Check SmartGuide CGM solution will be tested without the prediction function
  • SmartGuide CGM with Predict App (Device)
    SmartGuide CGM + Predict App Accu-Check SmartGuide CGM solution will be tested with the added benefit of the prediction function

Eligibility criteria

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)

Conditions

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 Ecological Momentary Assessment Glycemic Responses Glycemic Variability Glucose Control Continuous Glucose Monitoring System Prediction

Locations

  • Fidam Rdc — Bad Mergentheim, Baden-Wurttemberg, Germany
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record