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

NCT03387787 | Completed Phase 2

• 1 other identifier: UDEM_GlucoTab
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

GlucoTab, Tresiba, Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (24)

• 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)

• 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)

• Number of blood glucose measurements per day

  during the treatment period (at least 48 hours but maximal 21 days per patient)

• Number of missed blood glucose measurements

  during the treatment period (at least 48 hours but maximal 21 days per patient)

• Number of additionally required blood glucose measurements

  during the treatment period (at least 48 hours but maximal 21 days per patient)

Study Arms (1)

GlucoTab Treatment Arm

EXPERIMENTAL

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

Device: GlucoTab; Drug: Insulin Degludec

Interventions

GlucoTab 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.

GlucoTab Treatment Arm

Insulin Degludec DRUG

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

GlucoTab Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

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

Bern, 3010, Switzerland

Location

Related Links

• University Clinics of Neurosurgery
• The developers Homepage

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin degludec

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Markus Laimer, Prof. MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2017
• First Posted: January 2, 2018
• Study Start: January 30, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)