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CompletedNCT02053077Updated May 12, 2023Results posted

Risk Identification of the GlucoTab System in Routine Use

An observational study in Diabetes Mellitus, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-12.

Sponsored by Medical University of Graz · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study summary

Identification of risks of the GlucoTab system in routine use.

Read the detailed description

A study to identify risks in routine use of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.

02

Conditions studied

  • Diabetes Mellitus
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In context

Lead sponsor

Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

non-critically ill patients with type 2 diabetes at general wards

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week

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

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

Secondary outcomes

  1. Efficacy: Blood Glucose During Hospital Stay

    Efficacy: mean pre-breakfast blood glucose during hospital stay

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

  2. Usability: Coverage of the GlucoTab

    Usability: coverage of the GlucoTab treatment during hospital stay

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

07

Results

Posted Feb 8, 2021

Participant flow

Participant flow — Overall Study
MilestoneIntervention
Started150
Completed150
Not completed0

Outcome measures

PrimaryEfficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week

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

Time frame:
participants will be followed for the duration of hospital stay, an expected average of 1 week
Reported as:
Mean · mg/dl
Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week
mg/dlIntervention
Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week159 ± 32
SecondaryEfficacy: Blood Glucose During Hospital Stay

Efficacy: mean pre-breakfast blood glucose during hospital stay

Time frame:
participants will be followed for the duration of hospital stay, an expected average of 1 week
Reported as:
Mean · mg/dl
Efficacy: Blood Glucose During Hospital Stay
mg/dlIntervention
Efficacy: Blood Glucose During Hospital Stay147 ± 38
SecondaryUsability: Coverage of the GlucoTab

Usability: coverage of the GlucoTab treatment during hospital stay

Time frame:
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Reported as:
Mean · percentage of hospital stay
Usability: Coverage of the GlucoTab
percentage of hospital stayIntervention
Usability: Coverage of the GlucoTab71.4 ± 23.4

Adverse events

Collected over during hospital stay. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention—1/150 (0.7%)3/150 (2%)
Most frequent serious events
Most frequent serious events
EventIntervention
Pneumonia and cardiac decompensation requiring treatment in intensive care unitCardiac disorders1/150
Most frequent other events
Showing 10 of 12
Most frequent other events
EventIntervention
CystitisInfections and infestations3/150
Pleural effusionRespiratory, thoracic and mediastinal disorders1/150
AV Block Grad 3Cardiac disorders1/150
Haemorrhagic GastritisGastrointestinal disorders1/150
Antibiotic associated exanthemaSkin and subcutaneous tissue disorders1/150
Insult (Posteriorinfarction after intracardiac catheter)Vascular disorders1/150
Autoimmune hemolytic anemiaBlood and lymphatic system disorders1/150
CholecystolithiasisHepatobiliary disorders1/150
Aneurysma spurium right groinVascular disorders1/150
NSTEMICardiac disorders1/150

Baseline characteristics

Age, Continuous
Age, Continuous(years)Intervention
Mean68 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)Intervention
Female56
Male94
08

Study locations

1 site
  • Medical University of Graz
    Graz, Styria 8010, Austria
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02053077
Lead sponsor
Medical University of Graz
Responsible party
Pieber Thomas, MD (Univ. Prof. Dr., Medical University of Graz) — Principal investigator
First posted
Feb 3, 2014
Start date
Feb 2014
Primary completion
Jun 2016
Completion
Jun 26, 2016
Results posted
Feb 8, 2021
Last update
May 12, 2023

Study contacts

Thomas R. Pieber, Univ.Prof.Dr
principal investigator · Medical University of Graz

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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