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

NCT07814508 | Recruiting

• 1 other identifier: FIDAM-IIS-2501
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes (DM); Diabetes Mellitus; Diabetes Mellitus Type 2; Diabetes Mellitus Type 1; Diabetes Mellitus ( Type 1 and Type 2); Fear of Hypoglycemia; Sleep Quality; Diabetes Distress; Ecological Momentary Assessment; Glycemic Responses; Glycemic Variability; Glucose Control; Continuous Glucose Monitoring System; Prediction

Keywords

Accu-Chek SmartGuide CGM; Predict App solution; Diabetes Mellitus; Fear of Hypoglycemia; Continuous glucose monitoring system

Outcome Measures

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

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

Secondary Outcomes (10)

• Overall sleep quality (PSQI)

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

• Hypoglycemia confidence (HCS)

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

• Diabetes distress (DDS)

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

• Diabetes Empowerment (DES-SF)

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

• Daily sleep quality

  14 days after enrollment and 14 days before study end with two prompts per day (morning & evening)

Study Arms (2)

SmartGuide CGM without Predict App

ACTIVE COMPARATOR

Device: SmartGuide CGM without Predict App

SmartGuide CGM with Predict App

EXPERIMENTAL

Device: SmartGuide CGM with Predict App

Interventions

SmartGuide CGM without Predict App DEVICE

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

Also known as: continuous glucose monitoring without predictive algorithm, CGM without predictive algorithm, Accu-Check SmartGuide CGM without Predict App

SmartGuide CGM without Predict App

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

Also known as: continuous glucose monitoring with predictive algorithm, CGM with predictive algorithm, Accu-Check SmartGuide CGM and Predict App

SmartGuide CGM with Predict App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• FIDAM RDC: lead
• Roche Diabetes Care: collaborator

Study Sites (1)

Fidam Rdc

Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

RECRUITING

Related Publications (3)

• Ehrmann D, Laviola L, Priesterroth LS, Hermanns N, Babion N, Glatzer T. Fear of Hypoglycemia and Diabetes Distress: Expected Reduction by Glucose Prediction. J Diabetes Sci Technol. 2024 Sep;18(5):1027-1034. doi: 10.1177/19322968241267886. Epub 2024 Aug 19.

  PMID: 39158974 BACKGROUND

• Glatzer T, Ehrmann D, Gehr B, Penalba Martinez MT, Onvlee J, Bucklar G, Hofer M, Stangs M, Wolf N. Clinical Usage and Potential Benefits of a Continuous Glucose Monitoring Predict App. J Diabetes Sci Technol. 2024 Sep;18(5):1009-1013. doi: 10.1177/19322968241268353. Epub 2024 Aug 19.

  PMID: 39158995 BACKGROUND

• Hussain S, Polonsky W, Scibilia R, Glatzer T. Beyond the Trend Arrow: Potential Value of Artificial Intelligence-Supported Glucose Predictions for People with Type 1 Diabetes Using Continuous Glucose Monitoring Systems. Diabetes Technol Ther. 2025 Nov;27(11):943-949. doi: 10.1089/dia.2025.0293. Epub 2025 May 29.

  PMID: 40441551 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Sleep Initiation and Maintenance Disorders

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Dominic Ehrmann, Prof. Dr.

CONTACT

+49 7931 96192 42; ehrmann@fidam.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 5, 2026
• First Posted: September 11, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Locations

DE (1)