Safety and Initial Performance of the DiaGone Device on Type 2 Diabetes Patients
NCT ID: NCT03390322
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
31 participants
INTERVENTIONAL
2017-07-28
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Subjects who meet all inclusion and exclusion criteria after screening are hospitalized and go through the Duodenal Glycemic Control™ treatment.
Duodenal Glycemic Control™ treatment is conducted by a gastroenterologist, in an endoscopic suite, with an off-the-shelf endoscope, using the DiaGone™ system.
Patients are followed for 6 months for AE and SAE. Patients are followed for 12 months for glycemic control parameters.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Duodenal Glycemic Control™
DiaGone™
Duodenal Glycemic Control™ using the DiaGone™ system
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
DiaGone™
Duodenal Glycemic Control™ using the DiaGone™ system
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* HbA1c at 7.5%-12%
* On oral glucose lowering drugs in a stable medication regimen
* Fasting plasma glucose level at ≥125mg/dL
* BMI 25-40 Kg/m2
Exclusion Criteria
* Serum C peptide \<1ng/ml
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Digma Medical Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
IKEM
Prague, , Czechia
Soroka Medical Center
Beersheba, , Israel
Shaarei Tzedek
Jerusalem, , Israel
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Salinari S, Bertuzzi A, Guidone C, Previti E, Rubino F, Mingrone G. Insulin sensitivity and secretion changes after gastric bypass in normotolerant and diabetic obese subjects. Ann Surg. 2013 Mar;257(3):462-8. doi: 10.1097/SLA.0b013e318269cf5c.
Ferrannini E, Mingrone G. Impact of different bariatric surgical procedures on insulin action and beta-cell function in type 2 diabetes. Diabetes Care. 2009 Mar;32(3):514-20. doi: 10.2337/dc08-1762. No abstract available.
Mingrone G, Castagneto-Gissey L. Mechanisms of early improvement/resolution of type 2 diabetes after bariatric surgery. Diabetes Metab. 2009 Dec;35(6 Pt 2):518-23. doi: 10.1016/S1262-3636(09)73459-7.
de Jonge C, Rensen SS, Verdam FJ, Vincent RP, Bloom SR, Buurman WA, le Roux CW, Schaper NC, Bouvy ND, Greve JW. Endoscopic duodenal-jejunal bypass liner rapidly improves type 2 diabetes. Obes Surg. 2013 Sep;23(9):1354-60. doi: 10.1007/s11695-013-0921-3.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLD-008
Identifier Type: -
Identifier Source: org_study_id