N/A
N=150
Risk Identification of the GlucoTab System in Routine Use
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02053077 ↗Enrolled (actual)
150
Serious AEs
0.7%
Results posted
Feb 2021
Primary outcome: Primary: Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week — 159 mg/dl
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of Graz
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week |
159 | — |
| SECONDARY Efficacy: Blood Glucose During Hospital Stay |
147 | — |
| SECONDARY Usability: Coverage of the GlucoTab |
71.4 | — |
Summary
Identification of risks of the GlucoTab system in routine use.
Eligibility Criteria
Inclusion Criteria
- informed consent obtained after being advised of the nature of the study
- type 2 diabetes or new-onset hyperglycaemia which require s.c. insulin therapy during hospital stay
- diabetes therapy supported by GlucoTab system
Exclusion Criteria
- type 1 diabetes mellitus
- intravenous insulin therapy
- hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
- gestational diabetes or pregnancy
- known or suspected allergy to certain insulin types, named in the user manual
- total parenteral nutrition (TPN)
- any mental condition rendering the patient incapable of giving his consent
Data sourced from ClinicalTrials.gov (NCT02053077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.