Diabetes Mellitus
Conditions
Brief summary
Identification of risks of the GlucoTab system in routine use.
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.
Interventions
None listed
Sponsors
Medical University of Graz
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Blood Glucose During Hospital Stay | 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 |
| Usability: Coverage of the GlucoTab | Participants will be followed for the duration of hospital stay, an expected average of 1 week | Usability: coverage of the GlucoTab treatment during hospital stay |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Diabetes therapy was performed according to the intended use of the GlucoTab system | 150 |
| Total | 150 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 56 Participants |
| Sex: Female, Male Male | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 150 |
| serious Total, serious adverse events | 1 / 150 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Efficacy: Blood Glucose During Hospital Stay, an Expected Average of 1 Week | 159 mg/dl | Standard Deviation 32 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Efficacy: Blood Glucose During Hospital Stay | 147 mg/dl | Standard Deviation 38 |
Secondary
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
Population: Diabetes therapy was performed according to the intended use of the GlucoTab system
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Usability: Coverage of the GlucoTab | 71.4 percentage of hospital stay | Standard Deviation 23.4 |