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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 diabetes, or type 2 diabetes on intensive insulin treatment, who already use a continuous glucose monitor (CGM). They will test a CGM with predictive features for 6 weeks.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Type 1 diabetes, or type 2 diabetes with intensified insulin therapy (basal-bolus therapy with self-adjustment of bolus doses). HbA1c below 10% (86 mmol/mol).
- Earlier treatment
- Must have used a CGM without predictive features during the past 3 months. Must not use the SmartGuide CGM solution or an AID system.
- Biomarker or test result
- HbA1c below 10% (86 mmol/mol)
Main reasons for not taking part
- Already using the SmartGuide CGM solution
- Using an AID system
- Current treatment with psychiatric medications
- Diabetes for less than 3 months
- Current or planned pregnancy
Read by machine on 13 November 2026.
Where in Germany
- Fidam RdcBad Mergentheim, GermanyContact: Dominic Ehrmann, Prof. Dr.Taking 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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.