DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control by comparing the MD-Logic automated insulin delivery system to sensor augmented pump therapy in patients with type 1 diabetes at home.
Adolescent
Blood Glucose
/ metabolism
Blood Glucose Self-Monitoring
Circadian Rhythm
Cross-Over Studies
Diabetes Mellitus, Type 1
/ drug therapy
Female
Fuzzy Logic
Humans
Hypoglycemia
/ chemically induced
Hypoglycemic Agents
/ administration & dosage
Insulin
/ administration & dosage
Insulin Infusion Systems
Male
Monitoring, Ambulatory
Pancreas, Artificial
Young Adult
CSII
HbA1c
MDI
adolescents
closed loop
insulin pump
pediatric
type 1 diabetes
Journal
Diabetes, obesity & metabolism
ISSN: 1463-1326
Titre abrégé: Diabetes Obes Metab
Pays: England
ID NLM: 100883645
Informations de publication
Date de publication:
04 2019
04 2019
Historique:
received:
01
09
2018
revised:
02
11
2018
accepted:
13
11
2018
pubmed:
28
11
2018
medline:
8
9
2020
entrez:
28
11
2018
Statut:
ppublish
Résumé
Previous DREAM studies demonstrated the safety and efficacy of the CE marked MD-Logic closed-loop system (DreaMed GlucoSitter) in different settings for overnight glycaemic control. The present study aimed to evaluate the system for day and night use for 60 hours during the weekend at home compared to sensor-augmented pump (SAP) therapy in participants with type 1 diabetes. This was a prospective, multicentre, crossover, controlled study (clinicaltrials.gov NCT01238406). All participants were connected in randomized order for one weekend to SAP therapy or the MD-Logic System. In the intervention arm only, the amount of carbohydrate was entered into the bolus calculator; the rest of insulin delivery was automated and wireless via a tablet computer. The primary endpoint was percentage of glucose values between 70 and 180 mg/dL. The ITT population comprised 48 (19 males, 29 females) adolescents and adults experienced in sensor use: (median, [IQR]): age, 16.1years [13.2-18.5]; diabetes duration, 9.4 years [5.0-12.7]; pump use, 5.4 years [3.1-9.4]; HbA1c, 7.6% [7.0-8.1]. A significant increase in the percentage of time within target range (70-180 mg/dL) (66.6% vs 59.9%, P = 0.002) was observed with the closed-loop system vs control weekends with unchanged percentage of time below 70 mg/dL (2.3% vs 1.5%, P = 0.369). Mean weekend glucose level per participant was significantly lower (153 [142-175] vs 164 [150-186] mg/dL, P = 0.003). No safety signals were observed. The MD-Logic system was safe and associated with better glycaemic control than SAP therapy for day and night use. The absence of remote monitoring did not lead to safety signals in adapting basal rates nor in administration of automated bolus corrections.
Substances chimiques
Blood Glucose
0
Hypoglycemic Agents
0
Insulin
0
Banques de données
ClinicalTrials.gov
['NCT01238406']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
822-828Informations de copyright
© 2018 John Wiley & Sons Ltd.
Références
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