Evaluation of Glycaemic Control Using GlucoTab® With Insulin Degludec in Hospitalized Patients With Diabetes Mellitus Type 2

NCT ID: NCT03387787

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2020-01-30

Brief Summary

The GlucoTab® system is a computerized decision support system built of an android based front-end user interface and a backend server including the REACTION algorithm. GlucoTab® is able to process blood glucose data and physiological confounders of glycaemia. Subsequently, GlucoTab® provides patient-specific basal, bolus, and correction insulin doses together with visualization and documentation of relevant data. The GlucoTab® system was found capable to keep hospitalized diabetic patients in the recommended target range without increasing the risk for hypoglycaemic events. Insulin pharmacokinetic is a critical confounder of glycaemic variability and the main determinant of an algorithm-based decision support-system. GlucoTab® is intended for being used with a basal/bolus insulin regimen. Up to date, feasibility data are limited to the use of insulin glargine.

Insulin degludec, an ultra-long acting basal insulin is characterized by a stable pharmacokinetic profile a half-life of ~25 hours. It was found equally effective to insulin glargine with respect to glycaemic control, while the incidence of (nocturnal) hypoglycaemia was smaller in patients treated with insulin degludec. Within the present study, insulin glargine will be replaced by insulin degludec, which is not yet approved for dose titration with GlucoTab®.

In the present study, 15 non-critically ill T2DM patients, who were hospitalized at the University Clinic of Neurosurgery for various reasons and require insulin treatment will be recruited. Patients will be treated with insulin Tresiba and insulin Novorapid. For a maximum duration of 21 days, GlucoTab® will calculate the required insulin doses for each patient, depending on fasting plasma glucose and postprandial glucose measurements during the day. After the calculated Insulin dose has been approved by the physician, the nursing staff will give the dose to the respective patient.

The present study will analyse the efficacy of GlucoTab® for glycaemic management in T2DM patients using insulin degludec.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GlucoTab Treatment Arm

Recruited patients will be treated with insulin degludec and insulin aspart. insulin doses will be calculated by the GlucoTab system

Group Type: EXPERIMENTAL

GlucoTab

Intervention Type: DEVICE

The GlucoTab® system is a computerized decision support system built of an android based front-end user interface and a backend server including the REACTION algorithm. GlucoTab® is able to process blood glucose data and physiological confounders of glycaemia. Subsequently, GlucoTab® provides patient-specific basal, bolus, and correction insulin doses together with visualization and documentation of relevant data.

Insulin doses of recruited patients will be calculated by the GlucoTab System for at least 48 hours and a maximum duration of 21 days.

Insulin Degludec

Intervention Type: DRUG

During the study, patients will be treated with basal Insulin degludec

Interventions

GlucoTab

The GlucoTab® system is a computerized decision support system built of an android based front-end user interface and a backend server including the REACTION algorithm. GlucoTab® is able to process blood glucose data and physiological confounders of glycaemia. Subsequently, GlucoTab® provides patient-specific basal, bolus, and correction insulin doses together with visualization and documentation of relevant data.

Insulin doses of recruited patients will be calculated by the GlucoTab System for at least 48 hours and a maximum duration of 21 days.

Intervention Type: DEVICE

Insulin Degludec

During the study, patients will be treated with basal Insulin degludec

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent after being advised of every detail of the study
• Male or female sex
• Aged ≥ 18 years
• Known history of diabetes of at least 90 days
• Type 2 diabetes mellitus treated with either diet alone or any combination of oral antidiabetic agents and the absence of diabetic ketoacidosis for at least 90 days.
• HbA1c 6.5 - 10.0%

Exclusion Criteria

• Type 1 diabetes mellitus
• Gestational diabetes mellitus
• Pregnancy or currently breast-feeding women
• Known or suspected allergy to insulin degludec and/or insulin aspart
• Continuous parenteral nutrition
• Participation in another trial which may in the opinion of the investigator interfere with the software algorithm
• Any mental condition rendering the patient incapable of giving informed consent
• Any disease or condition which in the opinion of the investigator would interfere with the trial performance and/or the physical and/or psychosocial safety of the study participant
• Critically ill patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Laimer, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology, Diabetes, Clinical Nutrition & Metabolism, Universitsy Hospital Bern, Switzerland

Locations

Division of Endocrinology, Diabetes, Clinical Nutrition & Metabolism, University Hospital Berne, Switzerland

Bern, , Switzerland

Countries

Switzerland

Related Links

https://www.udem.insel.ch/de/

Division of Diabetes, Endocrinology, Clinical Nutrition \& Metabolism

https://neurochirurgie.insel.ch/

University Clinics of Neurosurgery

http://www.glucotab.at/de/

The developers Homepage

Other Identifiers

UDEM_GlucoTab

Identifier Type: -

Identifier Source: org_study_id