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Trial record 40 of 13515 for:    "Diabetes Mellitus"

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

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ClinicalTrials.gov Identifier: NCT03387787
Recruitment Status : Not yet recruiting
First Posted : January 2, 2018
Last Update Posted : January 2, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Device: GlucoTab Drug: Insulin Degludec Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate Glycaemic Control Using GlucoTab® With Insulin Degludec and Aspart in Hospitalized Patients With Diabetes Mellitus Type 2
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: GlucoTab Treatment Arm
Recruited patients will be treated with insulin degludec and insulin aspart. insulin doses will be calculated by the GlucoTab system
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




Primary Outcome Measures :
  1. Blood Glucose in target range in percent [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
    We measure mean percentage of blood glucose measurements in the target range of ≥5.6 mmol/l ≤7.8 mmol/l.

  2. Random blood glucose <9.9 mmol/l in percent [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
    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


Secondary Outcome Measures :
  1. Number of severe hypoglycaemic episodes (defined as symptomatic or asymptomatic hypoglycaemia requiring third party help) [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  2. 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) [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  3. Number of blood glucose measurements per day [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  4. Number of missed blood glucose measurements [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  5. Number of additionally required blood glucose measurements [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  6. Correction factor insulin dose per day [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
    As calculated by GlucoTab

  7. Basal factor insulin dose per day [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
    As calculated by GlucoTab

  8. Bolus insulin dose per day [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
    As calculated by GlucoTab

  9. Number of insulin injections per day [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  10. Number and reasons for non-performance of insulin injections per day [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  11. Adherence to the insulin dose suggestion of the GlucoTab® system [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  12. Mean daily blood glucose as calculated by pre-meal and bedtime blood glucose values: Overall and per treatment day [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  13. Mean pre-bedtime blood glucose [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  14. Mean pre-breakfast blood glucose [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  15. Mean pre-lunch blood glucose [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  16. Mean pre-dinner blood glucose [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  17. Blood glucose <2.2 mmol/l in percent [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  18. Blood glucose between 2.201-<3.9 mmol/l in percent [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  19. Blood glucose between 3.901-<5.5 mmol/l in percent [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  20. Blood glucose between 5.501- <7.8 mmol/l in percent [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  21. Blood glucose between 7.801-< 9.9 mmol/l in percent [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  22. Blood glucose between 9.901-<16.6 mmol/l in percent [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  23. Blood glucose ≥16.601 mmol/l in percent [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]
  24. 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 [ Time Frame: during the treatment period (at least 48 hours but maximal 21 days per patient) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387787


Contacts
Contact: Markus Laimer, PD Dr Phone: +41 (0)31 632 30 62 Markus.Laimer@insel.ch
Contact: Andreas Melmer, Dr PhD +41 31 632 40 70 Andreas.Melmer@insel.ch

Locations
Switzerland
Division of Endocrinology, Diabetes, Clinical Nutrition & Metabolism, University Hospital Berne, Switzerland Not yet recruiting
Berne, Switzerland, 3010
Contact: Markus Laimer, PD. Dr.    +41 31 63 2 30 62    Markus.Laimer@insel.ch   
Contact: Christoph Stettler, Prof. Dr.    +41 31 63 2 42 21    Christoph.Stettler@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Markus Laimer, PD. Dr. Division of Endocrinology, Diabetes, Clinical Nutrition & Metabolism, Universitsy Hospital Bern, Switzerland

Additional Information:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03387787     History of Changes
Other Study ID Numbers: UDEM_GlucoTab
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: January 2, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital Inselspital, Berne:
GlucoTab, Tresiba, Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs