RECRUITING

RESET System Pivotal Trial (Rev F)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET System for Glycemic Improvement in Patients with Inadequately Controlled Type 2 Diabetes and Obesity, the STEP-1 Study. A multi-center, double-blinded, randomized, sham-controlled trial to evaluate the safety and effectiveness of the RESET System plus moderate intensity lifestyle and dietary counseling compliant with 2024 ADA Standard of Care as compared to a sham control receiving moderate intensity lifestyle and dietary counseling. Both the treatment and sham group will practice medical management compliant with STEP-1 Study Guidelines. Patients will be randomized 3 (RESET):1 (Sham).

Official Title

A Randomized, Multi-Center, Pivotal Efficacy and Safety Study Evaluating the RESET® System for Glycemic Improvement in Patients With Inadequately Controlled Type 2 Diabetes and Obesity

Quick Facts

Study Start:2019-09-09

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04101669

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥22 years and ≤ 65 years 2. Have understood and signed the approved informed consent form 3. Diagnosis of type 2 diabetes 4. HbA1c ≥ 7.5% and ≤10% 5. BMI ≥30kg/m2 and ≤ 50kg/m2 6. Willing and able to comply with study requirements 7. Documented negative pregnancy test in women of childbearing potential 8. Women of childbearing potential not intending to become pregnant (continue to be on an approved form of birth control) for the duration of their trial participation, including post explant period. Women of child-bearing age without known sterilization will be placed on 1 form of birth-control to prevent unwanted pregnancies 9. At least one year of medical records available, including detailed medical therapy and dosing information 10. Failed to achieve adequate HbA1c reduction (\<7.5%) after dual therapy for at least 3-month stable dosage of diabetes medication(s), including insulin, metformin, SGLT-2 inhibitor, GLP-1 RA, Dual GLP-1/GIPR agonist or, other medications including meglitinides, sulfonylureas, thiazolidinediones, or DPP-4s.	1. Previous treatment with the RESET System 2. Previous GI surgery that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner, or abnormal GI anatomical finding that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner 3. Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance 4. Known history of liver disease (e.g., viral or autoimmune etiology, METAVIR grade 2 or higher fibrosis/cirrhosis from a biopsy within the past 6 months, but not including incidental fatty liver) 5. eGFR of less than 45 ml/min/1.73 m2 6. Prior history of an abscess requiring hospitalization, intravenous antibiotics or drainage 7. Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement 8. Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis 9. Fasting C-peptide \< 1.0 ng/mL 10. Triglyceride level \> 600 mg/dL 11. Vitamin D deficiency (\<20ng/ml) 12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy 13. Height \< 5 feet (152.4 cm) 14. Current alcohol addiction, current drug addiction or usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers 15. History of pancreatitis, including gallstone related pancreatitis (subsequent to which patient has cholecystectomy) 16. Diagnosis of osteopenia or osteoporosis or currently taking denosumab, romosozumab-aqqg, bisphosphonates or teriparatide 17. Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma) 18. Active or recent (less than 12 months) gastroesophageal reflux disease (GERD) unless treated with H2RAs not PPI. 19. Uncontrolled thyroid disease, including a history of thyroid cancer, hyperthyroidism, or taking thyroid hormone for any reason other than primary hypothyroidism (TSH level must be between 0.4-4) 20. Currently taking prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 9 months post implant procedure 21. Currently taking the following medications (within 30 days prior to randomization) and/or there is a need or expected need to use these medications during the trial 12 months post index procedure: 22. Active H. pylori 23. History of Crohn's disease, atresias or untreated stenoses 24. Abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or upper gastrointestinal bleeding conditions within 3 months of randomization 25. Patients may be disqualified for study inclusion for any condition determined by the PI that places the patient at undue risk 26. Poor dentition not allowing complete chewing of food 27. Enrolled in another investigational study within 3 months of screening for this study (enrollment in observational studies is permitted) 28. Residing in a location without ready access to study site medical resources 29. Documented weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization 30. Positive Fecal Immunochemical Test (FIT) at time of screening 31. History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan 32. No access to an active telephone and internet service for provision of Follow Up Schedule calls and electronic diary 33. Having donated blood or received a blood transfusion in the 90 days prior to baseline labs. Patients should agree not to donate blood during the study 34. Any condition that increases red cell turnover, such as thalassemia 35. Existence of (\>5 cm string test) Pseudomonas aeruginosa, Stenotrophomonas maltophilia and/or Klebsiella pneumoniae serotype K1 and K2 36. A known sensitivity to nickel or titanium 37. Do not meet the screening criteria for MRI (i.e., MRI unsafe, or MRI conditional but not appropriate for the region of interest) 38. Patients with history or suspicion of coronary artery disease

Inclusion Criteria

Exclusion Criteria

1. Age ≥22 years and ≤ 65 years
2. Have understood and signed the approved informed consent form
3. Diagnosis of type 2 diabetes
4. HbA1c ≥ 7.5% and ≤10%
5. BMI ≥30kg/m2 and ≤ 50kg/m2
6. Willing and able to comply with study requirements
7. Documented negative pregnancy test in women of childbearing potential
8. Women of childbearing potential not intending to become pregnant (continue to be on an approved form of birth control) for the duration of their trial participation, including post explant period. Women of child-bearing age without known sterilization will be placed on 1 form of birth-control to prevent unwanted pregnancies
9. At least one year of medical records available, including detailed medical therapy and dosing information
10. Failed to achieve adequate HbA1c reduction (\<7.5%) after dual therapy for at least 3-month stable dosage of diabetes medication(s), including insulin, metformin, SGLT-2 inhibitor, GLP-1 RA, Dual GLP-1/GIPR agonist or, other medications including meglitinides, sulfonylureas, thiazolidinediones, or DPP-4s.

1. Previous treatment with the RESET System
2. Previous GI surgery that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner, or abnormal GI anatomical finding that could preclude the ability to place the RESET Liner or affect the function of the RESET Liner
3. Hypoglycemia and/or DKA/HHNK in the last 6 months requiring 3rd party assistance
4. Known history of liver disease (e.g., viral or autoimmune etiology, METAVIR grade 2 or higher fibrosis/cirrhosis from a biopsy within the past 6 months, but not including incidental fatty liver)
5. eGFR of less than 45 ml/min/1.73 m2
6. Prior history of an abscess requiring hospitalization, intravenous antibiotics or drainage
7. Previous treatment for severe liver disease and/or biliary tract disease, including but not limited to, surgery, bile duct dilatation, and stent placement
8. Diagnosis of type 1 diabetes mellitus or having any history of ketoacidosis
9. Fasting C-peptide \< 1.0 ng/mL
10. Triglyceride level \> 600 mg/dL
11. Vitamin D deficiency (\<20ng/ml)
12. Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter, or known coagulopathy
13. Height \< 5 feet (152.4 cm)
14. Current alcohol addiction, current drug addiction or usage, of drugs such as, narcotics, opiates, or benzodiazepines and other addictive tranquilizers
15. History of pancreatitis, including gallstone related pancreatitis (subsequent to which patient has cholecystectomy)
16. Diagnosis of osteopenia or osteoporosis or currently taking denosumab, romosozumab-aqqg, bisphosphonates or teriparatide
17. Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
18. Active or recent (less than 12 months) gastroesophageal reflux disease (GERD) unless treated with H2RAs not PPI.
19. Uncontrolled thyroid disease, including a history of thyroid cancer, hyperthyroidism, or taking thyroid hormone for any reason other than primary hypothyroidism (TSH level must be between 0.4-4)
20. Currently taking prescription antithrombotic therapy (e.g. anticoagulant or antiplatelet agent) within 10 days prior to randomization and/or there is a need or expected need to use during the trial 9 months post implant procedure
21. Currently taking the following medications (within 30 days prior to randomization) and/or there is a need or expected need to use these medications during the trial 12 months post index procedure:
22. Active H. pylori
23. History of Crohn's disease, atresias or untreated stenoses
24. Abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or upper gastrointestinal bleeding conditions within 3 months of randomization
25. Patients may be disqualified for study inclusion for any condition determined by the PI that places the patient at undue risk
26. Poor dentition not allowing complete chewing of food
27. Enrolled in another investigational study within 3 months of screening for this study (enrollment in observational studies is permitted)
28. Residing in a location without ready access to study site medical resources
29. Documented weight loss of 5% total body weight (TBW) anytime during the 3 months preceding randomization
30. Positive Fecal Immunochemical Test (FIT) at time of screening
31. History or observation of psychological disorder or behavior which could preclude compliance to the treatment and follow up plan
32. No access to an active telephone and internet service for provision of Follow Up Schedule calls and electronic diary
33. Having donated blood or received a blood transfusion in the 90 days prior to baseline labs. Patients should agree not to donate blood during the study
34. Any condition that increases red cell turnover, such as thalassemia
35. Existence of (\>5 cm string test) Pseudomonas aeruginosa, Stenotrophomonas maltophilia and/or Klebsiella pneumoniae serotype K1 and K2
36. A known sensitivity to nickel or titanium
37. Do not meet the screening criteria for MRI (i.e., MRI unsafe, or MRI conditional but not appropriate for the region of interest)
38. Patients with history or suspicion of coronary artery disease

Contacts and Locations

Study Contact

Stephen J Linhares, BS

CONTACT

774-454-3259

slinhares@gidynamics.com

Aoife Devery, BS

CONTACT

617-528-8880

adevery@gidynamics.com

Principal Investigator

Christopher C Thompson, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

MedStar Health Research Institute

Washington, District of Columbia, 20010

United States

University of Miami Hospital

Miami, Florida, 33166

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Michigan Medicine, Division of Gastroenterology and Hepatology

Ann Arbor, Michigan, 48109

United States

Weill Cornell Medicine

New York, New York, 10021

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Morphic Medical Inc.

Christopher C Thompson, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-09

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2019-09-09

Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

Type 2 Diabetes
Obesity

Additional Relevant MeSH Terms

Diabetes type2
Obesity