E10
Conditions
Interventions
Group 1: In this post-market clinical investigation, the Continuous Glucose Monitoring System (CGM system) Accu-Chek SmartGuide (ACSG), in particular the associated Predict App, is examined.
The aim i
Sponsors
Roche Diabetes Care GmbH, Roche Diagnostics
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Clinical diagnosis of type 1 diabetes mellitus - Intensified insulin therapy (MDI: three or more insulin injections per day) - Use of a CGM system - HbA1c =10% - Willingness to use ACSG for their therapy during the study - An understanding of and willingness to follow the protocol - Signed informed consent
Exclusion criteria
Exclusion criteria: - Not willing to discontinue use of their own CGM system during study - Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment - Hypoglycemia unawareness - Severe acute or severe chronic illness that might pose additional risk to the subject during the course of the study (at the physician’s discretion) - Known severe skin reactions (including allergic contact dermatitis) or allergies to medical adhesives - Skin alteration at the insertion sites (e.g., severe psoriasis vulgaris, severe scarring, severe lipodystrophia, severe rash) - Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of reported menopause, sterilization or hysterectomy) - Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g., mental or visual incapacity, language barriers, alcohol or drug misuse - Planned MRI, CT, X-ray, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound planned during the course of the study - Employee or immediate family member of an employee of the sponsor or the clinical investigation site - Participation in another study at the time of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the change in diabetes management between the control phase and the intervention phase within the same subject. Diabetes management will be characterized by the following variables: Glycemic control metrics: -Percentage of time below 180 mg/dl -Percentage of time >250 mg/dl -Glycemic variability in terms of the coefficient of variation -Frequency of hypoglycemic episodes Diabetes management behavior: -Characterization and quantification of carbohydrate intake -Characterization and quantification of insulin doses -Number of app consultations and duration of app usage Due to the exploratory pilot character of the study, no single variable will be defined as primary endpoint. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Reliability of the 2h prediction function of ACSG compared to trend arrow-based prediction of ACSG and FSL3 - Patient-reported outcomes during the control phase and the intervention phase | — |
Countries
Germany
Contacts
Public ContactGuido Freckmann
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Outcome results
None listed