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Effect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: a randomised controlled trial protocol
- Source :
- BMJ Open
- Publication Year :
- 2018
- Publisher :
- BMJ Publishing Group, 2018.
-
Abstract
- IntroductionManual determination of insulin dosing largely fails to optimise glucose control in type 1 diabetes. Automated insulin delivery via closed-loop systems has improved glucose control in short-term studies. The objective of the present study is to determine the effectiveness of 6 months’ closed-loop compared with manually determined insulin dosing on time-in-target glucose range in adults with type 1 diabetes.Methods and analysisThis open-label, seven-centre, randomised controlled parallel group clinical trial will compare home-based hybrid closed-loop versus standard diabetes therapy in Australia. Adults aged ≥25 years with type 1 diabetes using intensive insulin therapy (via multiple daily injections or insulin pump, total enrolment target n=120) will undertake a run-in period including diabetes and carbohydrate-counting education, clinical optimisation and baseline data collection. Participants will then be randomised 1:1 either to 26 weeks of MiniMed 670G hybrid closed-loop system therapy (Medtronic, Northridge, CA, USA) or continuation of their current diabetes therapy. The hybrid closed-loop system delivers insulin automatically to address basal requirements and correct to target glucose level, while bolus doses for meals require user initiation and carbohydrate estimation. Analysis will be intention to treat, with the primary outcome time in continuous glucose monitoring (CGM) target range (3.9–10.0 mmol/L) during the final 3 weeks of intervention. Secondary outcomes include: other CGM parameters, HbA1c, severe hypoglycaemia, psychosocial well-being, sleep, cognition, electrocardiography, costs, quality of life, biomarkers of vascular health and hybrid closed-loop system performance. Semistructured interviews will assess the expectations and experiences of a subgroup of hybrid closed-loop users.Ethics and disseminationThe study has Human Research Ethics Committee approval. The study will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Results will be disseminated at scientific conferences and via peer-reviewed publications.Trial registration numberNCT12617000520336.
- Subjects :
- Insulin pump
Adult
Blood Glucose
medicine.medical_specialty
Time Factors
type 1 diabetes
medicine.medical_treatment
030209 endocrinology & metabolism
closed loop
Artificial pancreas
Diabetes Therapy
law.invention
03 medical and health sciences
0302 clinical medicine
Insulin Infusion Systems
Randomized controlled trial
law
Diabetes mellitus
medicine
Protocol
Humans
Hypoglycemic Agents
Insulin
Multicenter Studies as Topic
030212 general & internal medicine
Prospective Studies
Randomized Controlled Trials as Topic
Glycated Hemoglobin
Type 1 diabetes
business.industry
Blood Glucose Self-Monitoring
Australia
General Medicine
medicine.disease
Home Care Services
Hypoglycemia
Clinical trial
Diabetes and Endocrinology
Diabetes Mellitus, Type 1
Treatment Outcome
Emergency medicine
Quality of Life
Regression Analysis
business
Subjects
Details
- Language :
- English
- ISSN :
- 20446055
- Volume :
- 8
- Issue :
- 6
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi.dedup.....b0f3f5f7702a9cdb7b1edc3ca6aa4abd