Optimization of glycaemic control using a tablet-based insulin titration algorithm in hospitalized patients with type 2 diabetes

An open, single-centre, non-controlled feasibility study on the performance of a tablet based workflow and decision support system with incorporated software algorithm used for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003480-21-AT

Enrollment

Registered

2012-10-08

Start date

2012-11-05

Completion date

Unknown

Last updated

2013-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 2

Interventions

Trade Name: Novorapid Product Name: Insulin Aspart Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN ASPART CAS Number: 116094-23-6 Concentration unit: IU inte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent obtained after being advised of the nature of the study 2. Male or female aged 18 - 90 years (both inclusive) 3. Type 2 diabetes treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. Impaired renal function (serum creatinine =3.0mg/dL) 2. Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient 3. Pregnancy 4. Any mental condition rendering the patient incapable of giving his consent 5. Terminally ill patients 6. Participation in a trial within 3 months prior to this trial 7. Known or suspected allergy to insulin

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the performance (safety) of the new GlucoTab system in non-critically ill patients with type 2 diabetes at the general ward for the length of hospital stay, with a maximum of 21 days.;Secondary Objective: To investigate usability and efficacy of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward for the length of hospital stay, with a maximum of 21 days.;Primary end point(s): Percentage of actions the GlucoTab system supports either to capture BG values or provide insulin dose suggestions according to the REACTION algorithm.;Timepoint(s) of evaluation of this end point: At hospital discharge / transfer to other ward/department / if study period exceeds 21 days	—

Measure

Time frame

Main Objective: To investigate the performance (safety) of the new GlucoTab system in non-critically ill patients with type 2 diabetes at the general ward for the length of hospital stay, with a maximum of 21 days.;Secondary Objective: To investigate usability and efficacy of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward for the length of hospital stay, with a maximum of 21 days.;Primary end point(s): Percentage of actions the GlucoTab system supports either to capture BG values or provide insulin dose suggestions according to the REACTION algorithm.;Timepoint(s) of evaluation of this end point: At hospital discharge / transfer to other ward/department / if study period exceeds 21 days

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Secondary

Measure	Time frame
Secondary end point(s): Safety and Usability • Hypoglycaemia and possible attendant clinical symptoms, hypoglycaemic episodes requiring third party help • Number of blood glucose measurements per day, number of missed glucose measurements per day • Number and reasons for additionally required blood glucose measurements • Insulin dose - basal, bolus and supplemental insulin dose per day • Number of insulin injections per day • Number and reasons for non-performance of insulin injections per day • Adherence to the GlucoTab system • Malfunctions of the GlucoTab system • Other usability parameters like workload and workflow of treatment • Number of meals per day • Relevant concomitant medication (corticosteroids, continuous parenteral nutrition) Efficacy: • Mean blood glucose as calculated by premeal and bedtime glucose values per treatment day • Mean daily blood glucose as calculated by blood glucose values per treatment day • Pre-enrolment blood glucose • Number of glucose measurements in target (100-140 mg/dl), low-normal range (70–99 mg/dl, hypoglycaemic ranges (40-140-180 mg/dl, and hyperglycaemic ranges 180-140-180 mg/dl, and hyperglycaemic ranges 180-<300 mg/dl, =300 mg/dl);Timepoint(s) of evaluation of this end point: At hospital discharge / transfer to other ward/department / if study period exceeds 21 days	—

Measure

Time frame

Secondary end point(s): Safety and Usability • Hypoglycaemia and possible attendant clinical symptoms, hypoglycaemic episodes requiring third party help • Number of blood glucose measurements per day, number of missed glucose measurements per day • Number and reasons for additionally required blood glucose measurements • Insulin dose - basal, bolus and supplemental insulin dose per day • Number of insulin injections per day • Number and reasons for non-performance of insulin injections per day • Adherence to the GlucoTab system • Malfunctions of the GlucoTab system • Other usability parameters like workload and workflow of treatment • Number of meals per day • Relevant concomitant medication (corticosteroids, continuous parenteral nutrition) Efficacy: • Mean blood glucose as calculated by premeal and bedtime glucose values per treatment day • Mean daily blood glucose as calculated by blood glucose values per treatment day • Pre-enrolment blood glucose • Number of glucose measurements in target (100-140 mg/dl), low-normal range (70–99 mg/dl, hypoglycaemic ranges (40-140-180 mg/dl, and hyperglycaemic ranges 180-140-180 mg/dl, and hyperglycaemic ranges 180-<300 mg/dl, =300 mg/dl);Timepoint(s) of evaluation of this end point: At hospital discharge / transfer to other ward/department / if study period exceeds 21 days

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Countries

Austria

Contacts

Public ContactStudy Coordinator

Medizinische Universität Graz

julia.mader@medunigraz.at+4331638512383

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026