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Diabetes Technol Ther. 2019 Dec 19. doi: 10.1089/dia.2019.0400. [Epub ahead of print]

Prospective analysis of the impact of commercialised hybrid closed-loop system on glycaemic control, glycaemic variability and patient-related outcomes in children and adults: a focus on superiority over predictive low glucose suspend technology.

Author information

1
University Hospital Complex Badajoz, 54390, Avda. Elvas s/n, Badajoz, Spain, 06006; pilar.beato@salud-juntaex.es.
2
University Hospital Complex Badajoz, 54390, Badajoz, Spain; fibygamero@gmail.com.
3
University Hospital Complex Badajoz, 54390, Badajoz, Extremadura, Spain; lucialazarom@gmail.com.
4
Complejo Hospitalario Virgen de la Macarena, 16582, Sevilla, Andalucía, Spain; mmromeroperez@hotmail.com.
5
University Hospital Complex Badajoz, 54390, Badajoz, Extremadura, Spain; fcojavier.arroyo@gmail.com.

Abstract

BACKGROUND:

Automatization of insulin delivery by closed-loop systems represents a major step in type 1 diabetes (T1D) management. The aim of this study was to analyse the effect of the commercialised hybrid closed-loop system, the MiniMed 670G system, on glycaemic control, glycaemic variability and patient satisfaction.

METHODS:

A prospective study, including T1D patients consecutively starting on the 670G system in one adult and two paediatric hospitals, was performed. Baseline and 3-month visits were documented. Two weeks of data from the system were downloaded. Glycaemic variability measures were calculated. Adults and adolescents completed a set of questionnaires (Gold and Clarke scores, Hypoglycemia Fear Survey, Diabetes Quality of Life, Diabetes Treatment Satisfaction, Diabetes Distress Scale, Pittsburgh Sleep Quality Index).

RESULTS:

58 patients were included (age: 28±15 years (7-63), <18 years-old: 38% (n=22), 59% (n=34) females, previous use of SAP-PLGS: 60% (n=35)). HbA1c was reduced from 57±10 to 53±7 mmol/l (7.4±0.9% to 7.0±0.6%) (p<0.001) and time in range 70-180 mg/dl was increased from 63.0±11.4% to 72.7±8.7% (p<0.001). In patients with high baseline hypoglycaemia risk, time <54 mg/dl and <70 mg/dl were reduced from 0.9±1.1% to 0.45±0.7% (p=0.021) and from 3.3±2.8% to 2.1±2.1% (p=0.019), respectively. Glycaemic variability measures improved. Time in Auto Mode was 85±17%, the number of Auto Mode exits was 0.6±0.3/day and the number of alarms was 8.5±3.7/day. Fear of hypoglycaemia, diabetes quality of life, diabetes treatment satisfaction and diabetes distress improved, while the percentage of patients with poor sleep quality was reduced. The discontinuation rate was 3%.

CONCLUSION:

The commercialised hybrid closed-loop system improves glycaemic control and glycaemic variability in children and adults, reducing the burden of living with T1D.

PMID:
31855446
DOI:
10.1089/dia.2019.0400

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