NCT07814508Recruiting
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 89 (estimated)
- First submitted
- 5 Sept 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- FIDAM RDC
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07814508
What you commit to
- Study type: Interventional
- Planned participants: 89
- From 1 Feb 2026 to the primary completion date, 31 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with psychiatric medications
Other illness
- Diabetes duration \< 3 months
- Severe complications (e.g. kidney disease, cancer)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fidam Rdc Coordinator of this site? Confirm its status | Bad Mergentheim | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.