Glucose Sensor With Prediction App for Adults With Type 1 or Type 2 Diabetes
Tests a glucose sensor's prediction app in adults using insulin.
Plain-language title generated from the registry record
Registry title: Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App
Key facts
- Where
- Bad Mergentheim, GermanySee the site
Where in Germany
- Fidam RdcBad Mergentheim, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- FIDAM RDC
- Trial code
- NCT07814508
- Record updated
- 22 October 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: 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: Current treatment with psychiatric medications; Diabetes duration < 3 months; Severe complications (e.g. kidney disease, cancer); Use of the SmartGuide CGM solution; AID use; Current or planned pregnancy; Peripheral neuropathy that will impact sleep quality according to the judgement of the participant.