Can good blood glucose control be reached with a decision support system in patients who underwent stemm cell transplantation

Standardized tight blood glucose management versus usual glycaemic control in patients undergoing allogeneic stem cell transplantation – a pilot trial - The GISMO Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004418-27-AT

Enrollment

Registered

2015-03-18

Start date

2015-05-04

Completion date

Unknown

Last updated

2024-02-19

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

Conditions

Hyperglycaemic patients

Interventions

Trade Name: Novorapid Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: INSULIN ASPART CAS Number: 116094-23-6 Concentration unit: IU international unit(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Age between 18 and 60 years •Patients after allogeneic stem cell transplantation who are hospitalized for GVHD and have overt hyperglycaemia requiring glucose lowering treatment •Signed informed consent 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: •Known or suspected allergy to certain insulin types, named in the user manual •Total parenteral nutrition •Any mental condition rendering the patient incapable of giving his consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the feasibility of a randomized controlled trial investigating tight glycaemic control versus usual glycaemic management in subjects undergoing allogenic stem cell transplantation and after episodes of graft versus host reactions.;Secondary Objective: -To investigate the feasibility of the GlucoTab system in patients with steroid induced hyperglycaemia (values in target, hypo- and hyperglycaemic events) -To evaluate acceptance and satisfaction of medical and nursing staff ;Primary end point(s): The aim of this pilot study is to investigate whether tight glycaemic control by use of the GlucoTab device in subjects after HCT who develop GVHD is feasible to improve glycaemic control as compared to usual practice and to gain the required data on complication rates to finally plan a definitive multicenter trial to investigate the impact of a standardized, computer aided tight glycaemic control on complication rates and mortality in haematological patients.;Timepoint(s) of evaluation of this end point: Length of Gluco Tab Treatment	—

Measure

Time frame

Main Objective: To determine the feasibility of a randomized controlled trial investigating tight glycaemic control versus usual glycaemic management in subjects undergoing allogenic stem cell transplantation and after episodes of graft versus host reactions.;Secondary Objective: -To investigate the feasibility of the GlucoTab system in patients with steroid induced hyperglycaemia (values in target, hypo- and hyperglycaemic events) -To evaluate acceptance and satisfaction of medical and nursing staff ;Primary end point(s): The aim of this pilot study is to investigate whether tight glycaemic control by use of the GlucoTab device in subjects after HCT who develop GVHD is feasible to improve glycaemic control as compared to usual practice and to gain the required data on complication rates to finally plan a definitive multicenter trial to investigate the impact of a standardized, computer aided tight glycaemic control on complication rates and mortality in haematological patients.;Timepoint(s) of evaluation of this end point: Length of Gluco Tab Treatment

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Secondary

Measure	Time frame
Secondary end point(s): •Number of hypoglycaemic episodes requiring third party help •Number of blood glucose measurements per day •Number of missed blood glucose measurements per day •Number of additionally required blood glucose measurements •Insulin dose - basal, bolus and corrective insulin dose per day •Number of insulin injections per day •Number and reasons for non-performance of insulin injections per day •Relevant concomitant medication (corticosteroids, parenteral bolus nutrition) Usability •Adherence to the insulin dose suggestion of the GlucoTab system •User satisfaction with the GlucoTab system regarding the user interface and the provided functionality •Malfunctions of the GlucoTab system •Other usability parameters like user workload and support of treatment workflow Efficacy •Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day •Mean pre-breakfast blood glucose, mean pre-lunch blood glucose, mean pre-dinner blood glucose, mean bedtime blood glucose •Mean pre-enrolment blood glucose •Number and percentage of the following ranges: 0-140-140-<180 mg/dl, 180-<300 mg/dl, = 300 mg/dl ;Timepoint(s) of evaluation of this end point: Length of hospital stay and gluco tab treatment	—

Measure

Time frame

Secondary end point(s): •Number of hypoglycaemic episodes requiring third party help •Number of blood glucose measurements per day •Number of missed blood glucose measurements per day •Number of additionally required blood glucose measurements •Insulin dose - basal, bolus and corrective insulin dose per day •Number of insulin injections per day •Number and reasons for non-performance of insulin injections per day •Relevant concomitant medication (corticosteroids, parenteral bolus nutrition) Usability •Adherence to the insulin dose suggestion of the GlucoTab system •User satisfaction with the GlucoTab system regarding the user interface and the provided functionality •Malfunctions of the GlucoTab system •Other usability parameters like user workload and support of treatment workflow Efficacy •Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day •Mean pre-breakfast blood glucose, mean pre-lunch blood glucose, mean pre-dinner blood glucose, mean bedtime blood glucose •Mean pre-enrolment blood glucose •Number and percentage of the following ranges: 0-140-140-<180 mg/dl, 180-<300 mg/dl, = 300 mg/dl ;Timepoint(s) of evaluation of this end point: Length of hospital stay and gluco tab treatment

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Countries

Austria

Contacts

Public ContactSubinvestigator

Medizinische Universität Graz, Universitätsklinik

felix.aberer@medunigraz.at+4331638586113

Outcome results

None listed

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