Trial Outcomes & Findings for Risk Identification of the GlucoTab System in Routine Use (NCT NCT02053077)

NCT ID: NCT02053077

Last Updated: 2023-05-12

Results Overview

efficacy: mean daily blood glucose during hospital stay, an expected average of 1 week

• Recruitment status: COMPLETED
• Target enrollment: 150 participants
• Primary outcome timeframe: participants will be followed for the duration of hospital stay, an expected average of 1 week
• Results posted on: 2023-05-12

Participant Flow

Participant milestones

Measure	Intervention Diabetes therapy was performed according to the intended use of the GlucoTab system
Overall Study STARTED	150
Overall Study COMPLETED	150
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Risk Identification of the GlucoTab System in Routine Use

Baseline characteristics by cohort

Measure	Intervention n=150 Participants Diabetes therapy was performed according to the intended use of the GlucoTab system
Age, Continuous	68 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	94 Participants n=5 Participants

PRIMARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 1 week

efficacy: mean daily blood glucose during hospital stay, an expected average of 1 week

Outcome measures

Measure	Intervention n=150 Participants Diabetes therapy was performed according to the intended use of the GlucoTab system
Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week	159 mg/dl Standard Deviation 32

SECONDARY outcome

Timeframe: participants will be followed for the duration of hospital stay, an expected average of 1 week

Efficacy: mean pre-breakfast blood glucose during hospital stay

Outcome measures

Measure	Intervention n=150 Participants Diabetes therapy was performed according to the intended use of the GlucoTab system
Efficacy: Blood Glucose During Hospital Stay	147 mg/dl Standard Deviation 38

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an expected average of 1 week

Population: Diabetes therapy was performed according to the intended use of the GlucoTab system

Usability: coverage of the GlucoTab treatment during hospital stay

Outcome measures

Measure	Intervention n=150 Participants Diabetes therapy was performed according to the intended use of the GlucoTab system
Usability: Coverage of the GlucoTab	71.4 percentage of hospital stay Standard Deviation 23.4

Adverse Events

Intervention

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention n=150 participants at risk Diabetes therapy was performed according to the intended use of the GlucoTab system
Cardiac disorders Pneumonia and cardiac decompensation requiring treatment in intensive care unit	0.67% 1/150 • Number of events 1 • during hospital stay

Other adverse events

Measure	Intervention n=150 participants at risk Diabetes therapy was performed according to the intended use of the GlucoTab system
Infections and infestations Cystitis	2.0% 3/150 • Number of events 3 • during hospital stay
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.67% 1/150 • Number of events 1 • during hospital stay
Cardiac disorders AV Block Grad 3	0.67% 1/150 • Number of events 1 • during hospital stay
Gastrointestinal disorders Haemorrhagic Gastritis	0.67% 1/150 • Number of events 1 • during hospital stay
Skin and subcutaneous tissue disorders Antibiotic associated exanthema	0.67% 1/150 • Number of events 1 • during hospital stay
Vascular disorders Insult (Posteriorinfarction after intracardiac catheter)	0.67% 1/150 • Number of events 1 • during hospital stay
Blood and lymphatic system disorders Autoimmune hemolytic anemia	0.67% 1/150 • Number of events 1 • during hospital stay
Hepatobiliary disorders Cholecystolithiasis	0.67% 1/150 • Number of events 1 • during hospital stay
Vascular disorders Aneurysma spurium right groin	0.67% 1/150 • Number of events 1 • during hospital stay
Cardiac disorders NSTEMI	0.67% 1/150 • Number of events 1 • during hospital stay
Renal and urinary disorders Acute kidney injury	0.67% 1/150 • Number of events 1 • during hospital stay
Musculoskeletal and connective tissue disorders Spondylodicscitis LWS	0.67% 1/150 • Number of events 1 • during hospital stay

Additional Information

Thomas Pieber

MUG

Phone: 004331638512383

Email: thomas.pieber@medunigraz.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place