Actively Recruiting
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
Led by Hoffmann-La Roche · Updated on 2026-05-14
270
Participants Needed
18
Research Sites
89 weeks
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
R
Roche Diabetes Care
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Type 1 or Type 2 Diabetes Mellitus for at least 12 months before screening
- Using multiple daily insulin injections for at least six months before screening
- Performing self-monitoring of blood glucose without use of continuous or flash glucose monitoring in the last six months
- HbA1c level between 6% and 10% based on local laboratory analysis
You will not qualify if you...
- Untreated adrenal or thyroid insufficiency
- Severe visual impairment
- Significant kidney impairment with eGFR less than 30 ml/min in the past year
- Serious acute or chronic diseases posing risk to the participant
- Hematocrit more than 10% below lower normal limit
- Pregnancy, planned pregnancy, or breastfeeding (except those with menopause, sterilization, or hysterectomy)
- Allergy to adhesives used in the study devices
- Skin diseases at sensor application sites (e.g., psoriasis, bacterial infections)
- Sickle cell disease or hemoglobinopathy
- Planned elective surgery with general anesthesia during the study
- Current or expected acute use of glucocorticoids (oral, injectable, or intravenous)
- Medical conditions making it unsafe to target HbA1c below 7%, such as heart failure or recent cardiovascular events
- Chronic use of opioids or similar medications more than three times per week unless stopped at least 30 days before screening
- Use of hydroxyurea, levodopa, methyldopa, ascorbic acid, or high-dose aspirin unless stopped at least 30 days before screening
- Planned MRI, CT, X-ray, radiofrequency ablation, high-frequency heat, or high-intensity focused ultrasound during the study
- Planned flight or high-altitude hike above 3000 meters during baseline and assessment periods
- Shift work involving night shifts
- On or planning a diet intended for weight change
- Current abuse of illicit or prescription drugs or alcohol
- Any physical or psychological condition that could affect study adherence or conduct
- Dependence on study sponsors, investigators, or related companies
- Participation in another clinical study during this study period
AI-Screening
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Trial Site Locations
Total: 18 locations
1
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, Poland, 80-546
Actively Recruiting
2
Diabetes Technology Center, Jagiellonian University Medical College
Krakow, Poland, 31-501
Actively Recruiting
3
NZOZ Neuromed
Kraśnik, Poland, 23-204
Actively Recruiting
4
NZOZ Neuromed
Lublin, Poland, 20-064
Actively Recruiting
5
Institute of Rural Health
Lublin, Poland, 20-090
Actively Recruiting
6
KO-MED Centra Kliniczne Lublin II
Lublin, Poland, 30-362
Actively Recruiting
7
BioResearch Group Sp. z o. o.
Nadarzyn, Poland, 05-830
Actively Recruiting
8
Nbr Polska
Warsaw, Poland, 00-710
Actively Recruiting
9
Clinic of Internal Diseases, Endocrinology and Diabetology State Medical Institute MSWiA
Warsaw, Poland, 02-507
Actively Recruiting
10
ETG Warszawa
Warsaw, Poland, 02-677
Actively Recruiting
11
Baskent University Department of Endocrinology and Metabolism
Adana, Turkey (Türkiye), 01240
Actively Recruiting
12
Bakırköy Sadi Konuk Training and Research Hospital
Bakirkoy Istanbul, Turkey (Türkiye), 34147
Actively Recruiting
13
Koç University Hospital
Istanbul, Turkey (Türkiye), 34010
Actively Recruiting
14
Cerrahpasa Medical School Department of Endocrinology
Istanbul, Turkey (Türkiye), 34303
Actively Recruiting
15
Medical Faculty of Istanbul University, Division of Endocrinology and Metabolism
Istanbul, Turkey (Türkiye), 34303
Actively Recruiting
16
Göztepe Prof. Dr. Süleyman Yalçın City Hospital
Istanbul, Turkey (Türkiye), 34722
Actively Recruiting
17
Medeniyet University Hospital - İST (Prof. Dr. Süleyman Yalçın City Hospital, Internal Diseases)
Istanbul, Turkey (Türkiye), 34722
Actively Recruiting
18
Ümraniye Training and Research Hospital
Ümraniye / İstanbul, Turkey (Türkiye), 34764
Actively Recruiting
Research Team
S
Study ID Reference: DC000129 Roche Diabetes Care Poland and Turkey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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