An interventional study of Accu-Chek SmartGuide CGM Solution and Accu-Chek SmartGuide Sensor and Blinded Apps in Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, sponsored by Hoffmann-La Roche. Recruiting at 19 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Hoffmann-La Roche · Not applicable, Interventional, and Diagnostic
This is an open label, two-arm, randomized multi-center clinical device study in adult subjects with Type 1 diabetes (T1D) or insulin-dependent Type 2 diabetes (T2D) on a multiple daily injection (MDI) regime.
The goal of the study is to investigate the impact of the Accu-Chek SmartGuide CGM solution on the change in overall time in range (TIR) of blood glucose concentrations of 70-180 mg/dl compared with that using self-monitoring of blood glucose (SMBG).
Exclusion Criteria:
Device: Accu-Chek SmartGuide CGM Solution
Device: Accu-Chek SmartGuide Sensor and Blinded Apps · Device: SMBG Device
The Accu-Chek SmartGuide CGM solution is used for real-time continuous glucose monitoring (CGM) in the interstitial fluid. It consists of the Accu-Chek SmartGuide device and two smartphone applications (apps): the Accu-Chek SmartGuide app and the Accu-Chek SmartGuide Predict app. The Accu-Chek SmartGuide device contains a CGM sensor pre-assembled in a sensor applicator. It has connectivity to the smartphone that is running the Accu-Chek apps. The Accu-Chek SmartGuide app is the primary display of the real-time glucose values. The Accu-Chek SmartGuide Predict app is an information management tool that further visualizes and analyzes diabetes data from the Accu-Chek SmartGuide device.
The participants in the SMBG control group will wear a SmartGuide sensor with blinded SmartGuide apps intermittently, i.e., during the assessment periods. It is not possible to read out the glucose data from the blinded app, hence neither the SmartGuide app nor the SmartGuide Predict functionalities can be accessed by the participants in this group.
With the SmartGuide apps in blinded mode, participants in the SMBG control group will continue using their own SMBG device or they may use the Accu-Chek Instant meter that will be provided for calibration of the SmartGuide device.
Change in the Percentage of Time in Range of a Blood Glucose Concentration of 70 to 180 mg/dL from the Baseline Period to Assessment Period A
Time frame: Baseline Period (Weeks 1 and 2) and Assessment Period A (Weeks 5 and 6)
Change in the Percentage of Time in Range of a Blood Glucose Concentration of 70 to 180 mg/dL from the Baseline Period to Assessment Period B
Time frame: Baseline Period (Weeks 1 and 2) and Assessment Period B (Weeks 13 and 14)
Change in the Percentage of Time in Range of a Blood Glucose Concentration of 70 to 180 mg/dL from the Baseline Period to Assessment Period C
Time frame: Baseline Period (Weeks 1 and 2) and Assessment Period C (Weeks 25 and 26)
Percentage of Time in Tight Range of a Blood Glucose Concentration of 70 to 140 mg/dL by Study Period
Time frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Percentage of Time Above Range (Blood Glucose Concentration of >180 to ≤250 mg/dL) in Level 1 Hyperglycemia by Study Period
Time frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Percentage of Time Above Range (Blood Glucose Concentration >250 mg/dL) in Level 2 Hyperglycemia by Study Period
Time frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Percentage of Time Below Range (Blood Glucose Concentration of ≥54 to <70 mg/dL) in Level 1 Hypoglycemia by Study Period
Time frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Percentage of Time Below Range (Blood Glucose Concentration <54 mg/dL) in Level 2 Hypoglycemia by Study Period
Time frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Number of Level 1 Hypoglycemia Events by Study Period
A level 1 hypoglycemia event is defined as a blood glucose concentration of ≥54 to \<70 mg/dL for at least 15 minutes.
Time frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Number of Level 2 Hypoglycemia Events by Study Period
A level 2 hypoglycemia event is defined as a blood glucose concentration of \<54 mg/dL for at least 15 minutes.
Time frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Average Glucose Management Indicator, as an Estimate of HbA1c, by Study Period
Time frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Average Blood Glucose Concentration by Study Period
Time frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Average Glycemic Variability in Blood Glucose Concentration by Study Period
Time frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Average HbA1c Values from the Central Laboratory
Time frame: Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Average Daily Insulin Dose
Time frame: Baseline (Week 1), Weeks 5, 13, and 25
Average Number of Daily Insulin Boluses Injected
Time frame: Baseline (Week 1), Weeks 5, 13, and 25
Average Daily Amount of Carbohydrates Consumed
Time frame: Baseline (Week 1), Weeks 5, 13, and 25
Hypoglycemia Fear Survey-II (HFS-II) Score at Specified Timepoints
Time frame: Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Diabetes Distress Scale 17 (DDS-17) Questionnaire Score at Specified Timepoints
Time frame: Baseline (Week 1 Day 1), Week 15 Day 1, and Week 27 Day 1
Ecological Momentary Assessment (EMA) Questionnaire Score at Specified Timepoints
Time frame: Baseline Period (Weeks 1 and 2), Assessment Periods A (Weeks 5 and 6), B (Weeks 13 and 14), and C (Weeks 25 and 26)
Number of Participants by Their Responses to the Roche Diabetes Care SmartGuide Usability Questionnaire (Group A Only)
Time frame: Week 27 Day 1
Number of Healthcare Providers (HCP) by Their Responses to the Roche Diabetes Care HCP Accu-Chek Care Questionnaire
Time frame: Week 27 Day 1
Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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