Safety and Initial Performance of the DiaGone Device on Type 2 Diabetes Patients
DiaGone™ First in Human (FIH) Study - Safety and Performance of the DiaGone™ Device for the Treatment of Type 2 Diabetes
1 other identifier
interventional
31
2 countries
3
Brief Summary
This is a multi-center, prospective, open label study of the Duodenal Glycemic Control™ procedure on type 2 diabetes patients sub-optimally controlled, to examine the safety and initial performance of the DiaGone™ system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Jul 2017
Longer than P75 for not_applicable diabetes-mellitus-type-2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 28, 2017
CompletedFirst Submitted
Initial submission to the registry
December 26, 2017
CompletedFirst Posted
Study publicly available on registry
January 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedDecember 18, 2024
August 1, 2024
7.1 years
December 26, 2017
December 15, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of procedure related SAEs.
7 days
Incidence of procedure related SAEs.
6 months
Secondary Outcomes (3)
Change to Fasting Glucose levels
12 months
Change to Post Prandial Glucose levels
12 months
Change to HbA1c levels
12 months
Study Arms (1)
Duodenal Glycemic Control™
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subjects who are ≥ 18 years and ≤ 75 years of age.
- 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
You may not qualify if:
- Diagnosed Type I diabetes
- Serum C peptide \<1ng/ml
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
IKEM
Prague, Czechia
Soroka Medical Center
Beersheba, Israel
Shaarei Tzedek
Jerusalem, Israel
Related Publications (4)
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.
PMID: 23388352BACKGROUNDFerrannini 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.
PMID: 19246589BACKGROUNDMingrone 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.
PMID: 20152737BACKGROUNDde 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.
PMID: 23526068BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2017
First Posted
January 4, 2018
Study Start
July 28, 2017
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
December 18, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share