Trial document
DRKS00015119
Trial Description
Title
Pilot study to evaluate glycemic control with GlucoTab using an ultra-long acting insulin analogue in non-critically ill patients with type 2 diabetes at the general ward
Trial Acronym
Glucotab_Degludec
URL of the Trial
[---]*
Brief Summary in Lay Language
This study enrolls patients over the age of 18 with manifest type 2 diabetes mellitus, which aims to improve glycemic control by using GlucoTab, an electronic insulin dose decision support system. The GlucoTab system supports clinical staff. It automatically suggests the amount of insulin to be administered by medical staff using an insulin calculation scheme.
The goal is to reduce elevated blood sugar levels during acute illness and hospitalization.
Brief Summary in Scientific Language
This open-label, single-center, prospective clinical Trial evaluates the possibility to monitor the glycemic control in patients over the Age of 18 with type 2 diabetes mellitus when using the GlucoTab system with Insulin Degludec (Tresiba). Patients with type 2 diabetes or newly diagnosed hyperglycemia will be included in this study.
Hyperglycaemia in hospitalized patients is one of the most common and cost intensive problems of today's healthcare and is often associated with poor disease outcome and mortality. Poor glycaemic control is also associated with prolongation in hospitalization, infections, post-discharge disabilities, and death. The current guidelines recommend a fasting blood sugar value of <140 mg / dl. Insulin, either administered intravenously or subcutaneously should be the first choice for controlling the blood glucose in hospitalized patients. An algorithm for basal-bolus therapy has been developed with the electronic decision support system GlucoTab. In this study, the feasibility of glycemic control with the ultra-long-acting insulin degludec (Tresiba) in hospitalized patients using GlucoTab is being evaluated. Insulin Degludec is thought to reduce the number of hypoglycemic events. A subcutaneous glucose sensor is placed in the subcutaneous tissue of all participants. During the hospital stay, for a maximum of 21 days, the blood sugar of the study participants is managed with GlucoTab. Parameters such as plasma glucose, subcutaneous glucose, insulin dose and concomitant medication will be collected during the ward round. Capillary blood glucose measurements will be done before meals and at bedtime. If there is no meal intake, an appropriate correction insulin dose will be administered, if necessary. The GlucoTab algorithm calculates the amount of insulin to be administered based on the blood sugar profile of the last 24 hours. The dose of insulin suggested by GlucoTab can be overruled by a physician at any time. The study ends for the participants as soon as they are discharged from the ward.
Organizational Data
- DRKS00015119
- 2019/04/29
- [---]*
- yes
- Approved
- 30-491 ex 17/18, Ethikkommission der Medizinischen Universität Graz Auenbruggerplatz 2 8036 Graz Austria
Secondary IDs
- 2018-002646-36
Health Condition or Problem studied
- E11 - Type 2 diabetes mellitus
Interventions/Observational Groups
-
Patients suffering from type 2 diabetes mellitus equal or over the age of 18 will be included in this study. After obtaining informed consent, body measurements (body weight, height and body mass index [calculated as body weight/(height)2), vital signs (diastolic and systolic blood pressure, pulse, body temperature], renal function parameters and routine laboratory parameters [HbA1c, creatinine, blood glucose] as recorded in the patient file will be documented. A urine pregnancy test in female participants of childbearing potential will also be performed. Glinide, Sulfonylureas and Glitazones will be stopped, Metformin, SGLT2-inhibitors, GLP-1 analogues and DPP-4-inhibitors will be continued and and subjects will be treated with GlucoTab and the integrated algorythm for basal bolus therapy using insulin degludec and insulin aspart. Subjects has to stay equal or longer than 48 hours on the general ward to be inculded in the study. The duration of the study is the length of the hospital stay or a maximum of 21 days after admission. Blood glucose measurements and insulin dosing is performed and documented by the nurse on duty. The suggested insulin dose can be overruled by the treating physician at any time and/or an additional glucose measurement
At discharge patients will return to their previous antidiabetic treatment, unless a further insulin therapy is indicated by the treating physician.
Blinded continuous subcutaneous glucose monitoring (CGM) will be performed throughout the study to better understand glycemic excursions over time.
Characteristics
- Interventional
- [---]*
- Single arm study
- Open (masking not used)
- [---]*
- Uncontrolled/Single arm
- Treatment
- Single (group)
- IV
- No
Primary Outcome
Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured ≥ 24 hours after start of therapy
Secondary Outcome
Number of hypoglycemic episodes requiring third party help
Number of blood glucose measurements per day
Number of missed blood glucose measurements per day
Number of additionally required blood glucose measurements
Insulin dose - basal, bolus and corrective insulin dose per day
Number of insulin injections per day
Number and reasons for non-performance of insulin injections per day
Relevant concomitant medication (corticosteroids, parenteral nutrition, oral hypoglycemic agents)
Adherence to the insulin dose suggestion of the GlucoTab system
Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day
Mean pre-breakfast blood glucose, mean prelunch blood glucose, mean pre-dinner blood glucose, mean bedtime blood glucose
Mean pre-enrolment blood glucose
Number and percentage of the following ranges: 0-<40 mg/dl, 40-<70 mg/dl, 70-<100 mg/dl, 100140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl.
Time of glucose measurements (CGM) in the following ranges: 40-<70 mg/dl, 70-<100 mg/dl, 100-140 mg/dl, >140-<180 mg/dl, 180-<300 mg/dl, ≥ 300 mg/dl
Countries of Recruitment
- Austria
Locations of Recruitment
- University Medical Center
Recruitment
- Planned
- 2019/05/15
- 30
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Informed consent obtained after being advised of the nature of the study
Male or female aged ≥18 years
Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycemia which requires s.c. insulin therapy
Exclusion Criteria
Type 1 diabetes, gestational diabetes
Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
continuous subcutaneous insulin infusion (CSII)
hyperglycaemic episodes (ketoacidosis, hyperosmolar state) if they require intravenous insulin therapy
Pregnancy
Any mental condition rendering the patient incapable of giving his consent
Known or suspected allergy to insulin degludec or insulin aspart
Continuous parenteral nutrition
Participation in another trial which can influence outcome of the trial
Addresses
-
start of 1:1-Block address primary-sponsor
- Univ.-Klinik für Innere MedizinKlinische Abteilung für Endokrinologie und Diabetologie
- Mr. Univ.-Prof. Dr. Thomas Pieber
- Auenbruggerplatz 15
- 8036 Graz
- Austria
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- +43 / 316 / 385-12383
- +43 / 316 / 385-13428
- thomas.pieber at medunigraz.at
- http://inneremedizin.uniklinikumgraz.at/endokrinologie
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Medizinische Universität Graz
- Ms. Ass. Prof. Dr. Julia Mader
- Auenbruggerplatz 2
- 8036 Graz
- Austria
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +43 316 385 82382
- +43 316 385 14332
- julia.mader at medunigraz.at
- [---]*
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Medizinische Universität Graz
- Ms. Ass. Prof. Dr. Julia Mader
- Auenbruggerplatz 2
- 8036 Graz
- Austria
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +43 316 385 82382
- +43 316 385 14332
- julia.mader at medunigraz.at
- [---]*
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- LKH Universitätsklinikum GrazAbteilung für Endokrinologie & Diabetologie
- Auenbruggerplatz 15
- 8036 Graz
- Austria
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- +43 316 385 80254
- +43 316 385 14332
- julia.mader at medunigraz.at
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting planned
- [---]*