Predictive CGM with App for people with type 1 or insulin-treated type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this remote, six-week, pre-post study, adults with type 1 or insulin-treated type 2 diabetes use the Accu-Chek SmartGuide CGM for two weeks without predictive features, then four weeks with the Predict App. Online questionnaires assess fear of hypoglycemia, sleep quality, confidence in preventing hypoglycemia, diabetes distress, and empowerment, along with glucose trends and alarm responses. The trial compares outcomes between the two phases to see if predictive features add benefit. No in-person visits are required, and the study is conducted in Germany via the dia*link online panel.

Why it matters

Who can join: the full rules

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)

Where it's running

• Fidam Rdc
  Bad Mergentheim, Baden-Wurttemberg, Germany Recruiting

Study contacts

• Study coordinator: Dominic Ehrmann, Prof. Dr.
• Email: ehrmann@fidam.de
• Phone: +49 7931 96192 42

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.