Summary of clinical investigation plan for The DIATEC trial: in-hospital diabetes management by a diabetes team and continuous glucose monitoring or point of care glucose testing – a randomised controlled trial

Mikkel Thor Olsen*, Carina Kirstine Klarskov, Ulrik Pedersen-Bjergaard, Katrine Bagge Hansen, Peter Lommer Kristensen

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Abstract

Background
Worldwide, up to 20 % of hospitalised patients have diabetes mellitus. In-hospital dysglycaemia increases patient mortality, morbidity, and length of hospital stay. Improved in-hospital diabetes management strategies are needed. The DIATEC trial investigates the effects of an in-hospital diabetes team and operational insulin titration algorithms based on either continuous glucose monitoring (CGM) data or standard point-of-care (POC) glucose testing.

Methods
This is a two-armed, two-site, prospective randomised open-label blinded endpoint (PROBE) trial. We recruit non-critically ill hospitalised general medical and orthopaedic patients with type 2 diabetes treated with basal, prandial, and correctional insulin (N = 166).

In both arms, patients are monitored by POC glucose testing and diabetes management is done by ward nurses guided by in-hospital diabetes teams. In one of the arms, patients are monitored in addition to POC glucose testing by telemetric CGM viewed by the in-hospital diabetes teams only. The in-hospital diabetes teams have operational algorithms to titrate insulin in both arms. Outcomes are in-hospital glycaemic and clinical outcomes.

Discussion
The DIATEC trial will show the glycaemic and clinical effects of in-hospital CGM handled by in-hospital diabetes teams with access to operational insulin titration algorithms in non-critically ill patients with type 2 diabetes. The DIATEC trial seeks to identify which hospitalised patients will benefit from CGM and in-hospital diabetes teams compared to POC glucose testing. This is essential information to optimise the use of healthcare resources before broadly implementing in-hospital CGM and diabetes teams.
OriginalsprogEngelsk
Artikelnummer60
TidsskriftBMC Endocrine Disorders
Vol/bind24
Udgave nummer1
Antal sider8
ISSN1472-6823
DOI
StatusUdgivet - 2024

Bibliografisk note

Funding Information:
We are grateful for the valuable inputs to the trial design from study nurses Rikke Carstensen and Pernille Banck-Petersen from NOH and from in-hospital diabetes nurses Susanne M. M. Houe, Mette Riis, Camilla M. Mathiesen, Louise E. Thomsen, and in-hospital consultant specialised in endocrinology Mette P. Sonne from HGH. MTO is the coordinating investigator of trial sites NOH and HGH. PLK is the sponsor and principal investigator at NOH with email: [email protected]. KBH is the principal investigator at HGH. Additional authors are sub-investigators.

Publisher Copyright:
© The Author(s) 2024.

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