Table 5: Summary of extended PICO to define research question that assessment will investigate Patients Intervention Comparator Outcomes to be Healthcare resources to be assessed considered Patients for DIAMOND™ Primary HbA1c IPG device all who PBS system Comparator Weight loss Gastric leads listed oral (plus OMT) 1: OAD Adverse events Insertion, removal or medications Complications replacement of IPG device medications that are associated with Insertion, removal or have failed or providing T2DM replacement of gastric leads are inadequate Hypoglycaemic Professional/clinic visits inappropriate control events Anaesthesia and as an 2: Injectable Quality of Hospital stay alternative to therapy life/utilities Endoscopy injectable Secondary Mortality GP visits therapies. Comparator Ongoing interrogation of device 1: Bariatric Prophylactic antibiotics surgery Endocrinologist visit Anti-diabetic medications Anti-diabetic monitoring Management of adverse events/complications Outpatient visits Emergency service Abbreviations: AEs, adverse events; OAD, Oral Anti-diabetic; OMT (optimal medical therapy) Blood tests will be included in the economic evaluation to monitor and identify patients who are inadequately controlled on standard oral glucose lowering (anti-diabetic) therapy. This will include home based blood glucose monitoring, HbA1c levels, triglycerides and cholesterol levels. Healthcare resources Using Table 6 provide a list of the health care resources whose utilisation is likely to be impacted should the proposed intervention be made available as requested Some of the health care resources whose utilisation is likely to be impacted should the proposed intervention be made available: Surgeon specialist time Hospital bed days Anaesthesia specialist time Anti-diabetic medications General practitioner time Accident and emergency visits
Table 5: Summary of extended PICO to define research question that assessment will investigate Patients Intervention Comparator Outcomes to be assessed Healthcare resources to be considered Patients for who all PBS listed oral medications have failed or are inappropriate and as an alternative to injectable therapies. DIAMOND™ system (plus OMT) Primary Comparator 1: OAD medications that are providing inadequate control 2: Injectable therapy Secondary Comparator 1: Bariatric surgery HbA1c Weight loss Adverse events Complications associated with T2DM Hypoglycaemic events Quality of life/utilities Mortality IPG device Gastric leads Insertion, removal or replacement of IPG device Insertion, removal or replacement of gastric leads Professional/clinic visits Anaesthesia Hospital stay Endoscopy GP visits Ongoing interrogation of device Prophylactic antibiotics Endocrinologist visit Anti-diabetic medications Anti-diabetic monitoring Management of adverse events/complications Outpatient visits Emergency service Abbreviations: AEs, adverse events; OAD, Oral Anti-diabetic; OMT (optimal medical therapy) Blood tests will be included in the economic evaluation to monitor and identify patients who are inadequately controlled on standard oral glucose lowering (anti-diabetic) therapy. This will include home based blood glucose monitoring, HbA1c levels, triglycerides and cholesterol levels. Healthcare resources Using Table 6 provide a list of the health care resources whose utilisation is likely to be impacted should the proposed intervention be made available as requested Some of the health care resources whose utilisation is likely to be impacted should the proposed intervention be made available: Surgeon specialist time Hospital bed days Anaesthesia specialist time Anti-diabetic medications General practitioner time Accident and emergency visits