STAR Study Investigating Performance and Safety of the Medical Device SiPore15™

Inclusion criteria

• Signed informed consent form.
• Male or female aged ≥18 years on the day of screening.
• Female subjects of childbearing potential must be on non-oral contraceptives, postmenopausal or sterile.
• Prediabetes or newly diagnosed T2D (not on blood sugar lowering drugs) defined as HbA1c levels: ≥42 to ≤57 mmol/mol (≥6.0 to ≤7.5%-according to DCCT).
• Body mass index (BMI) >25 kg/m2 and > or = 40 kg/m2.
• Stable weight for 3 months (+/-5 kg).
• No extreme changes in diet for the last 6 months such as anorexia, bulimia, etc.
• Subject must be able and willing to attend all scheduled visits and comply with all study procedures with no planned holiday longer than 2 weeks during the 12 weeks of treatment.

Exclusion criteria

• Diagnosed with type1 diabetes/Latent Autoimmune Diabetes in Adult (LADA) or secondary diabetes, as part of medical history or confirmed by laboratory test.
• Previous or current Metformin treatment or other glucose reducing drug therapy within 3 months before screening visit.
• Previous or current statin treatment or other blood lipid (LDL) reducing drug therapy, within 12 months before screening visit.
• Previous or current medication known to cause weight loss or weight gain, such as systemic corticosteroids, thyroid hormones or Estrogen, within 1 month before screening visit.
• Subjects who stopped smoking within 6 months before screening visit.
• Diagnosed with chronic somatic diseases, except for obesity and treatment naive T2D, that in the opinion of the investigator may therefore affect metabolic and /or intestinal function (e.g. inflammatory bowel disease, intestinal dysfunction, pancreatic dysfunction, other causes of malabsorption, recent (past 6 months) neoplastic disease.
• Any history of myocardial infarction or stroke within the 6 months before screening visit.
• Anemia, donated blood or other major blood loss within 3 months from screening visit that in the opinion of the clinician may interfere with the study.
• Pregnancy or breast feeding.
• Allergies to silicon dioxide.
• A diagnosed state that requires use of vitamin and/or mineral supplements during the study.
• Previous major gastric surgery that may affect the study outcome, such as bariatric surgery.
• Ongoing or unstable kidney condition with moderate to great reduction in glomerular filtration rate < 90 ml/min (GFR) that may affect metabolic parameters during the trial.
• Ongoing or unstable liver condition that may cause changes in liver enzymes exceeding 2x upper normal levels.
• Psychiatric or cognitive disorder and/or behavioral problems which in the opinion of the clinician may interfere with the study.
• History of or ongoing alcohol or drug addiction.
• Participation in any study involving an investigational drug or medical device within the past 30 days before the screening visit.
• Belongs to a vulnerable population or has any condition such that his/her ability to provide informed consent, comply with the follow-up requirements, or provide self- assessments is compromised (e.g. homeless, developmentally disabled and prisoner).
• Is a relative of the Investigator or an employee at the clinical study site.