title: Psychological outcomes of evening and night closed-loop insulin delivery under free living conditions in people with Type 1 diabetes: a 2-month randomized crossover trial.
abstract: To assess the impact on fear of hypoglycaemia and treatment satisfaction with an artificial pancreas system used for 2 consecutive months, as well as participant acceptance of the artificial pancreas system.
  
  
  
  In a randomized crossover trial patient-related outcomes associated with an evening-and-night artificial pancreas and sensor-augmented pump therapy were compared. Both intervention periods lasted 8 weeks. The artificial pancreas acceptance questionnaire (range 0-90, higher scores better), Hypoglycaemia Fear Survey II (range 0-72, higher scores worse) and Diabetes Treatment Satisfaction Questionnaire (range 0-36, higher scores better) were completed by 32 participants. Semi-structured interviews were conducted after study completion in a subset of six participants. Outcomes were compared using a repeated-measures anova model or paired t-test when appropriate.
  
  
  
  The total artificial pancreas acceptance questionnaire score at the end of the artificial pancreas period was 69.1 (sd 14.7; 95% CI 63.5, 74.7), indicating a positive attitude towards the artificial pancreas. No significant differences were found among the scores at baseline, end of sensor-augmented pump therapy period or end of the artificial pancreas period with regard to fear of hypoglycaemia [28.2 (sd 17.5), 23.5 (sd 16.6) and 23.5 (sd 16.7), respectively; P = 0.099] or diabetes treatment satisfaction [29.0 (sd 3.9), 28.2 (sd 5.2) and 28.0 (sd 7.1), respectively; P = 0.43]. Themes frequently mentioned in the interviews were 'positive effects at work', 'improved blood glucose', 'fewer worries about blood glucose', but also 'frequent alarms', 'technological issues' and 'demand for an all-in-one device'.
  
  
  
  The psychological outcomes of artificial pancreas and sensor-augmented pump therapy were similar. Current artificial pancreas technology is promising but user concerns should be taken into account to ensure utility of these systems.
authors.affiliation: Internal Medicine F4-222, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Kropff
authors.affiliation: Internal Medicine F4-222, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: DeJong
authors.affiliation: Information Engineering, University of Padova, Padova, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Del Favero
authors.affiliation: Endocrinology, Diabetes, Nutrition, Montpellier University Hospital, Montpellier, France.
authors.forename: J
authors.initials: J
authors.lastname: Place
authors.affiliation: Civil Engineering and Architecture, University of Pavia, Pavia, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Messori
authors.affiliation: Endocrinology, Diabetes, Nutrition, Montpellier University Hospital, Montpellier, France.
authors.forename: B
authors.initials: B
authors.lastname: Coestier
authors.affiliation: Endocrinology, Diabetes, Nutrition, Montpellier University Hospital, Montpellier, France.
authors.forename: A
authors.initials: A
authors.lastname: Farret
authors.affiliation: Internal Medicine, University of Padova, Padova, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Boscari
authors.affiliation: Internal Medicine, University of Padova, Padova, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Galasso
authors.affiliation: Internal Medicine, University of Padova, Padova, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Avogaro
authors.affiliation: Internal Medicine, University of Padova, Padova, Italy.
authors.forename: D
authors.initials: D
authors.lastname: Bruttomesso
authors.affiliation: Information Engineering, University of Padova, Padova, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Cobelli
authors.affiliation: Endocrinology, Diabetes, Nutrition, Montpellier University Hospital, Montpellier, France.
authors.forename: E
authors.initials: E
authors.lastname: Renard
authors.affiliation: Civil Engineering and Architecture, University of Pavia, Pavia, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Magni
authors.affiliation: Internal Medicine F4-222, Academic Medical Centre, Amsterdam, The Netherlands.
authors.forename: J H
authors.initials: JH
authors.lastname: DeVries
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000378:metabolism; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000378:metabolism; D005239:Fear / Q000523:psychology*; D005260:Female; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000523:psychology*; D007004:Hypoglycemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage* / Q000009:adverse effects; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D019397:Pancreas, Artificial; D017060:Patient Satisfaction; D011795:Surveys and Questionnaires
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin