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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Pilot Study to Evaluate Glycaemic Control Using GlucoTab® With Insulin Degludec and Aspart in Hospitalized Patients With Diabetes Mellitus Type 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387787
• Other study ID #: UDEM_GlucoTab
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 30, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: March 2023
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Device:
• 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.

Drug:
• Insulin Degludec
During the study, patients will be treated with basal Insulin degludec

Locations

Country	Name	City	State
Switzerland	Division of Endocrinology, Diabetes, Clinical Nutrition & Metabolism, University Hospital Berne, Switzerland	Berne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose in target range in percent	We measure mean percentage of blood glucose measurements in the target range of =5.6 mmol/l =7.8 mmol/l.	during the treatment period (at least 48 hours but maximal 21 days per patient)
Primary	Random blood glucose <9.9 mmol/l in percent	We measure random daily blood glucose concentrations <9.9 mmol/l as calculated by all pre-prandial and bedtime glucose values measured =24 hours after start of insulin therapy	during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Number of severe hypoglycaemic episodes (defined as symptomatic or asymptomatic hypoglycaemia requiring third party help)		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Number of overall hypoglycaemic episodes defined as any measurement of capillary glucose concentrations =3.9 mmol/l with or without symptoms related to low blood glucose, according to the current definition of the American Diabetes Association (ADA)		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Number of blood glucose measurements per day		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Number of missed blood glucose measurements		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Number of additionally required blood glucose measurements		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Correction factor insulin dose per day	As calculated by GlucoTab	during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Basal factor insulin dose per day	As calculated by GlucoTab	during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Bolus insulin dose per day	As calculated by GlucoTab	during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Number of insulin injections per day		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Number and reasons for non-performance of insulin injections per day		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Adherence to the insulin dose suggestion of the GlucoTab® system		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Mean daily blood glucose as calculated by pre-meal and bedtime blood glucose values: Overall and per treatment day		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Mean pre-bedtime blood glucose		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Mean pre-breakfast blood glucose		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Mean pre-lunch blood glucose		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Mean pre-dinner blood glucose		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Blood glucose <2.2 mmol/l in percent		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Blood glucose between 2.201-<3.9 mmol/l in percent		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Blood glucose between 3.901-<5.5 mmol/l in percent		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Blood glucose between 5.501- <7.8 mmol/l in percent		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Blood glucose between 7.801-< 9.9 mmol/l in percent		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Blood glucose between 9.901-<16.6 mmol/l in percent		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Blood glucose =16.601 mmol/l in percent		during the treatment period (at least 48 hours but maximal 21 days per patient)
Secondary	Time of glucose measurements derived from CGM in the following ranges: 0-<2.2 mmol/l, 2.201-<3.9 mmol/l, 3.901-<5.5 mmol/l, 5.501-<7.8 mmol/l, 7.801-<9.9 mmol/l, 9.901-<16.6 mmol/l, =16.601 mmol/l		during the treatment period (at least 48 hours but maximal 21 days per patient)

External Links

•   Division of Diabetes, Endocrinology, Clinical Nutrition & Metabolism
•   The developers Homepage
•   University Clinics of Neurosurgery