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

Torben Biester, Judith Nir, Kerstin Remus, Alon Farfel, Ido Muller, Sarah Biester, Eran Atlas, Klemen Dovc, Nataša Bratina, Olga Kordonouri, Tadej Battelino, Moshe Philip, Thomas Danne, Revital Nimri

Research output: Contribution to journalArticlepeer-review

26 Scopus citations

Abstract

Aims: 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. Methods: 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. Results: 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. Conclusions: 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.

Original languageEnglish
Pages (from-to)822-828
Number of pages7
JournalDiabetes, Obesity and Metabolism
Volume21
Issue number4
DOIs
StatePublished - Apr 2019
Externally publishedYes

Bibliographical note

Publisher Copyright:
© 2018 John Wiley & Sons Ltd

Keywords

  • CSII
  • HbA1c
  • MDI
  • adolescents
  • closed loop
  • insulin pump
  • pediatric
  • type 1 diabetes

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this