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Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus

ConditionsType 1 Diabetes MellitusType 2 Diabetes Mellitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHoffmann-La Roche

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Type 1 Diabetes mellitus (T1D) or Type 2 Diabetes mellitus (T2D) diagnosed at least 12 months prior to screening, using multiple daily injection (MDI) regime for at least six months prior to screening

Performing SMBG, no CGM/flash glucose monitoring (FGM) use during the last six months prior screening

HbA1c ≥8% and ≤10% based on analysis from a local laboratory

Disqualifiers

Untreated adrenal or thyroid insufficiency

Severe visual impairment

Significant renal impairment: eGFR <30 ml/min within last one year

Serious acute or chronic concomitant disease or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject

Trial design

Design model

Parallel

Treatments tested in this trial

  • Accu-Chek SmartGuide CGM Solution

    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.

  • Accu-Chek SmartGuide Sensor and Blinded Apps

    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.

  • SMBG Device

    Device

    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.

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: Group A: Accu-Chek SmartGuide CGM SolutionExperimental treatment 1 intervention
Group B: Group B: Self-Monitoring of Blood Glucose (SMBG)Other 2 interventions

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

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

Hoffmann-La Roche

Lead sponsor

Roche Diabetes Care

Collaborator

Source ClinicalTrials.gov
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