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

Phase

2/3

Condition

Diabetes Prevention

Diabetes And Hypertension

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT03387787

UDEM_GlucoTab

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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 oralantidiabetic agents and the absence of diabetic ketoacidosis for at least 90 days.
HbA1c 6.5 - 10.0%

Exclusion

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 interferewith 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 withthe trial performance and/or the physical and/or psychosocial safety of the studyparticipant
Critically ill patients

Study Design

January 30, 2018

January 30, 2020

Connect with a study center

Division of Endocrinology, Diabetes, Clinical Nutrition & Metabolism, University Hospital Berne, Switzerland
Berne, 3010
Switzerland
Site Not Available

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