About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
Use of the SmartGuide CGM solution
AID use
Current treatment with psychiatric medications
Diabetes duration < 3 months
Trial design
Single group
Treatments tested in this trial
SmartGuide CGM without Predict App
DeviceSmartGuide CGM without Predict App Accu-Check SmartGuide CGM solution will be tested without the prediction function
SmartGuide CGM with Predict App
DeviceSmartGuide CGM + Predict App Accu-Check SmartGuide CGM solution will be tested with the added benefit of the prediction function
Treatment groups
Trial outcomes
Primary outcomes
Fear of hypoglycemia (HFS-II)
Within-person change in fear of hypoglycemia from baseline to follow-up, assessed via the Hypoglycemia-Fear Survey II questionnaire
Secondary outcomes
Overall sleep quality (PSQI)
Changes will be analyzed using a questionnaire
Hypoglycemia confidence (HCS)
Changes will be analyzed using a questionnaire
Diabetes distress (DDS)
Changes will be analyzed using a questionnaire: Diabetes distress (DDS: total score + subscale scores), Hypoglycemia-related distress, Powerlessness
Diabetes Empowerment (DES-SF)
Changes will be analyzed using a questionnaire
Sponsors and contacts
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FIDAM RDC
Lead sponsor
Roche Diabetes Care
Collaborator