BSPED2019 ORAL COMMUNICATIONS Oral Communications 3 (2 abstracts)
1Brighton & Sussex University Hospitals NHS Trust, Brighton, UK; 2Parent, Brighton, UK
Introduction: The use of Closed Loop (CL) system has slowly progressed from using a short time overnight to prolonged periods under everyday living conditions. In the last few years, Do-It-Yourself Closed Loop (DIY-CL) technology has become openly available as part of patient-led global initiative (#Wearenotwaiting) outside the conventional regulatory pathways, raising many medico-legal and ethical dilemmas.
Methods: Majority of the DIY-CL users are adults; we describe using this new technology as a parent-led initiative for 2 years in an adolescent. Type 1 diabetes (T1D) was diagnosed at 3.5 years in 2008; Islet Cell antibodies were positive at diagnosis; and patients father was known to have T1D too.
Results:
Time Period | Age (Years) | Insulin Regimen* | Average Insulin dose (units/kg per day) | Mean HbA1c (mmol/mol) (%) |
20092010 | 45 | BD | 0.78 | 66 (8.2%) |
201116 | 611 | CSII | 0.82 | 54 (7.1%) |
2017 | 12 | CSII + CGM | 0.79 | 55 (7.2%) |
20182019 | 1314 | DIY-CL | 1.03 | 41 (5.9%) |
Time Period | Age (Years) | Insulin Regimen* | Average Insulin dose (units/kg per day) | Mean HbA1c (mmol/mol) (%) |
20092010 | 45 | BD | 0.78 | 66 (8.2%) |
201116 | 611 | CSII | 0.82 | 54 (7.1%) |
2017 | 12 | CSII + CGM | 0.79 | 55 (7.2%) |
20182019 | 1314 | DIY-CL | 1.03 | 41 (5.9%) |
CGM sensor data capture over 90 days in AprJun 2019 was 97.2%; lost readings were mainly due to sensor warm up.
Parents reported numerous advantages (improved sleep & quality of life; no fear of hypoglycaemia; decreased diabetes care burden) and broadly no disadvantages, but high costs if not funded. Adolescent reported many advantages (100% school attendance; easy to check if system not working, less obvious than pump and no huge effect on sugar levels if a bolus dose is missed!) and no disadvantages.
Description | Glucose Value (mmol/l) | Number of readings | % of time |
Euglycaemia | 410 | 22 819 | 92.4% |
Level 1 Hypoglycaemia | 33.9 | 683 | 2.8% |
Level 2 Hypoglycaemia | <2.9 | 142 | 0.6% |
Level 1 Hyperglycaemia | 10.113.9 | 1003 | 4.0% |
Level 2 Hyperglycaemia | >13.9 | 59 | 0.2% |
Conclusions: DIYCL system appears safe and effective in reducing hypoglycaemia, minimising hyperglycaemia and achieving good HbA1c consistently over 2 years, even during adolescence. It improved quality of life for patient & family and decreased diabetes burden for them. Many ethical dilemmas, especially the non-regulated off-license use of this technology, still persist.