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Trial - ACTRN12621001340820


Column Value
Trial registration number ACTRN12621001340820
Full text link
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Ngai Wah Cheung

Contact
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

wah.cheung@sydney.edu.au

Registration date
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-10-06

Recruitment status
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1) have a confirmed diagnosis of COVID-19 2) are in a non-ICU ward, and are not imminently to be admitted to ICU or discharged 3) have known diabetes or newly diagnosed diabetes (diagnosed on an HbA1c >=6.5 mmol/L) 4) have had at least one fingerprick glucose level >=12 mmol/L since the commencement of dexamethasone.

Exclusion criteria
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

1) pregnant 2) type 1 diabetes 3) eGFR <30

Number of arms
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Prof NW Cheung

Inclusion age min
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

80

Countries
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Australia

Type of patients
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

160

primary outcome
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

The primary outcome is the mean daily glucose level during the course of the trial. This will be calculated from glucose readings taken from before and after meals. Both formal venous and fingerprick glucose measurements will be accepted.[Daily pre and post meals; from the day of randomisation to the final day that the patient is in the trial.]

Notes
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 4

Arms
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 1981, "treatment_name": "Isophane insulin", "treatment_type": "Hormones", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]