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 20 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Hoffmann-La Roche · Not applicable, Interventional, and Diagnostic
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Among 15 studies in Diabetes Mellitus, Type 1 by Hoffmann-La Roche — 1 open to participants now, 1 under way, none of them phase 3. Diabetes Mellitus, Type 1 · Hoffmann-La Roche.
Among the 15 studies in Diabetes Mellitus, Type 1 by Hoffmann-La Roche, this one has the largest planned enrollment, is the only one that started in 2025, is one of 13 with no phase, and was the 15th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →1 of the 15 studies in Diabetes Mellitus, Type 1 by Hoffmann-La Roche is open now, in 2 countries.
By country, each count listing its studies:
Of the 412 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 258 (63%) stop at 75 or younger; 185 take children under 18; 64 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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15 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 270 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 80 across the 15 interventional studies. Of the 14 that completed or were terminated, 6 (43%) have results posted.
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Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
1 of the studies in Diabetes Mellitus, Type 1 by Hoffmann-La Roche that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06704672Hoffmann-La RocheClinical 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 | 2026-11-15 |
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Among the 15 studies in Diabetes Mellitus, Type 1 by Hoffmann-La Roche, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Not enrolling at this site.
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
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Nov 2026, 19 months after the start.
Of 105 industry-sponsored interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's planned 19 months is above that.
Counting every sponsor, half of 950 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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