Changes in Person-reported Outcomes and Behavior Using the Accu-Chek SmartGuide CGM and Predict App

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFIDAM RDC

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • SmartGuide CGM without Predict App

    Device

    SmartGuide CGM without Predict App Accu-Check SmartGuide CGM solution will be tested without the prediction function

  • SmartGuide CGM with Predict App

    Device

    SmartGuide CGM + Predict App Accu-Check SmartGuide CGM solution will be tested with the added benefit of the prediction function

Treatment groups

89 Participants
are divided into 2 treatment groups
Group A: SmartGuide CGM without Predict AppActive comparator 1 intervention
Group B: SmartGuide CGM with Predict AppExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)

Secondary outcomes

1

Overall sleep quality (PSQI)

Changes will be analyzed using a questionnaire

Time frame
At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
2

Hypoglycemia confidence (HCS)

Changes will be analyzed using a questionnaire

Time frame
At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
3

Diabetes distress (DDS)

Changes will be analyzed using a questionnaire: Diabetes distress (DDS: total score + subscale scores), Hypoglycemia-related distress, Powerlessness

Time frame
At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
4

Diabetes Empowerment (DES-SF)

Changes will be analyzed using a questionnaire

Time frame
At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

FIDAM RDC

Lead sponsor

Roche Diabetes Care

Collaborator