Feasibility and Acceptance of A Medtronic Next Generation Hybrid Closed Loop (Artificial Pancreas) System

Not Applicable

Active, not recruiting

• Conditions: Type 1 Diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12622000017729
• Lead Sponsor: St Vincent's Hospital Melbourne

Brief Summary

Results TBD

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-11
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Age greater than or equal to 18 years; T1D of >1 year duration; stable on insulin pump therapy for >3 months; proficient in carbohydrate counting; continuous glucose monitoring (CGM) sensor experience; HbA1c <10.0%.
Participants must have enrolled in a previously registered study in order to participate in this study (ACTRN12620000687998).

Exclusion Criteria

Pregnancy; eGFR<40; a history of diabetic ketoacidosis in the last 3 months; diabetic gastroparesis; tape allergy; unable to exercise; major medical or psychiatric illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Satisfaction measured by the Difference in the Diabetes Technology Questionnaire (DTQ) Change Score. [Treatment satisfaction will be determined at baseline (previous 12-weeks of original HCL treatment), after Stage 1 completion (12 weeks post-enrolment; most recent commercially available HCL treatment) and after Stage 2 completion (24 weeks post-enrolment; Investigational HCL treatment).]

Secondary Outcome Measures

Name	Time	Method
Glycaemic outcomes as measured via continuous glucose monitoring will be standardized according to convention as described by Maahs et al. across each 12-week period, including:<br>CGM % time spent in target glycaemia ([a] 3.9-10.0 mmol/L and [b] 3.9-7.8 mmol/L); hyperglycaemia (>10.0 mmol/L, >13.9mmol/L); hypoglycaemia (<3.9 mmol/L, <3.5 mmol/L, <3.0 mmol/L, and <2.8 mmol/L).<br>[Assessed daily from enrolment up to 12 weeks (Stage 1; most recent commercially available HCL treatment), then daily from 12 weeks to 24 weeks post-enrolment (Stage 2; Investigational HCL treatment).];HbA1c will be determined using a serum assay at baseline and at the end of the 12-week intervention. [HbA1c will be determined at the end of each 12 week stage - i.e. at 12 weeks and 24 weeks post-commencement of study]