CGM

The study is to evaluate the accuracy and safety of a real-time CGM system among adult patients with type 1 diabetes with respect to reference venous plasma sample measurements.

* Rationale: Glucose control in patients with kidney disease is challenging, as traditional metrics can be unreliable and there is a high risk of hypoglycemia (low blood sugar). Although RT-CGM has shown benefits in other groups, its efficacy in patients with advanced kidney damage needs to be validated to improve their quality of life and prevent disease progression. * Main objective: To determine whether the use of RT-CGM is more effective than usual care (capillary blood glucose monitoring with a glucometer) in maintaining patients within an optimal glucose range (70-180 mg/dL) over a three-month period. * Study population: We plan to include 30 patients over 18 years of age with type 2 diabetes and chronic kidney disease (with a glomerular filtration rate less than 60 ml/min), who use insulin and are not on renal replacement therapy such as dialysis. * Methodology: The study is a randomized clinical trial consisting of two phases: 1. Selection period (15 days): Blinded monitoring is performed to obtain baseline data. 2. Treatment period (90 days): Patients are divided into two groups: the intervention group, which will use the CGM-RT with alarms configured for high and low levels, and the control group, which will continue with traditional fingerstick monitoring. * Metrics to be evaluated: In addition to time in range, researchers will analyze episodes of hypoglycemia and hyperglycemia, glycemic variability, glycated hemoglobin (HbA1c) levels, and device accuracy. * Ethical and logistical considerations: The study complies with international and national regulations, guaranteeing the confidentiality and autonomy of the participants. The project has a 24-month timeline and a detailed budget to cover medical personnel, monitoring sensors (Sinocare i3), and laboratory tests.

Aim The investigators aim to investigate if automated insulin delivery systems (AID) improve in-hospital glycemic and clinical outcomes in patients with type 2 diabetes compared to standard-of-care with a pen-basal-bolus insulin regimen manually titrated by general staff at Herlev-Gentofte Hospital and a clinical decision support system (GlucoTab) titrating the basal-bolus regimen automatically daily at Graz University Hospital. Population Hospitalized patients with type 2 diabetes in non-intensive care units (non-ICU) at medical wards at Copenhagen University Hospitals of Herley-Gentofte (affiliated with Steno Diabetes Center Copenhagen) and Medical University Hospital of Graz (N = 92). Design This is an investigator-initiated, two-armed, two-site, prospective, randomized, open-label, blinded endpoint (PROBE) trial. Objectives The objective is to determine the glycemic and clinical effects of inpatient AID systems in non-ICU patients with type 2 diabetes. Participants will be randomized in a usual-of-care and an AID arm. Diabetes management will be performed by usual care in the control arm based on a basal-bolus insulin regimen and point-of-care (POC) glucose testing. A continuous glucose monitoring (CGM) system (Abbott FreeStyle Libre 3) will be used in all groups for outcome analysis and comparison between the groups. The CGM will be blinded for the control arm, to not interfere with the usual of care because of the higher amount of glucose data. The AID-arm will be managed by an AID system with real-time CGM data transmitted to nursing stations. Outcomes Primary outcome: The primary outcome is the difference in CGM-recorded time in range (TIR) (70-180 mg/dl (3.9-10.0 mmol/l)) between the POC- and the CGM-arm according to the 2023 in-hospital CGM consensus during the entire hospital stay. Secondary outcomes: Outcomes are reported according to the 2023 in-hospital CGM consensus and specified in the protocol during the entire hospital stay, including three levels of time above range (TAR) 180-250mg/dl (10.0-13.9 mmol/l), \>250mg/dl (\>13.9 mmol/l), and \>180mg/dl (\>10.0 mmol/l); three levels of time below range (TBR) 54-70mg/dl (3.0-3.9 mmol/l), \<54mg/dl (\<3.0 mmol/l), and \<70mg/dl (\<3.9 mmol/l); events of hypoglycemia in three levels, 54-68mg/dl (3.0-3.8 mmol/l), \<54mg/dl (\< 3.0 mmol/l), and \<70mg/dl (\<3.9 mmol/l), where the glucose values between the two hypoglycemic events must all be \>70mg/dl (\>3.9 mmol/l) for at least 15 consecutive minutes(1), including prolonged hypoglycemic events (\> 120 minutes), recurrent hypoglycemic events (events preceded by another hypoglycemic event), and recurrent hypoglycemic days (percentage of days with at least one hypoglycemic event on separate days that is preceded by another in-hospital day with hypoglycemia(1)); mean glucose level; standard deviation (SD) of the CGM glucose distribution; coefficient of variation (CV); and insulin doses during hospitalization. Clinical outcomes: The investigator assess the length of hospital stay as calculated from time of admission until discharge; in-hospital mortality; admissions to intensive care unit; any in-hospital-related complications occurring at least one day after randomization and until discharge, as documented and defined by the treating physician in the electronic health record (e.g., acute kidney injurie, sepsis, etc.) Method For the usual-of-care-arm, glucose assessment is done by standard POC glucose testing and insulin is manually titrated by general staff at Herlev-Gentofte Hospital and the glucose assessment is done by standard POC glucose testing and insulin is manually titrated by the GlucoTab system titrating the basal-bolus regimen automatically daily at Graz University Hospital. For the AID-arm, CGM data informs in real time the mylife Ypsopump for automated insulin delivery. Device The investigational device is the AID system, containing of the mylife YpsoPump and the FreeStyle Libre 3 sensor.

Main objective: The goal is to to determine the accuracy of Dexcom G7 Continuous glucose monitor system in critically ill patients, undergoing major abdominal surgery and solid organ transplantation, in the intensive care unit. On admission to the intensive care unit or at the end of surgery, two Dexcom G7 sensors are placed in the infraclavicular position. Sensor number 1 will be blinded and will only be active when paired with the receiver, without the ability to monitor glucose levels. Sensor number 2 is used for continuous glucose monitoring and can be used to adjust the insulin dose. Patients will wear the continuous glucose monitoring sensor for a maximum of 10 days, including the time spent in the intensive care unit and the immediate care unit. The study will not interfere with any usual care clinical workflows. Calibration is only performed on an unblinded sensor. The reference method for calibration is the glucose from the blood glucose meter. Calibrate on the first day of monitoring: 4 times a day after approximately 6 hours, or if the blood glucose reading from the blood glucose meter is not within the estimated error range of the continuous glucose monitor (difference greater than 1,5mmol/L). Calibration on days 2 and 3 of monitoring: once in the morning, or when the meter's glucose reading is not within the estimated error range of the continuous glucose monitoring (difference greater than 1,5mmol/L) On subsequent days when the blood glucose meter reading is not within the estimated error range of continuous glucose monitoring (difference greater than 1,5mmol/L). Hypothesis: * Ho: No difference in mean absolute relative difference (MARD) between calibrated and non-calibrated sensors. * Ha: Calibrated sensors have lower mean absolute relative difference (δ = 4%, SD = 5%). Further objectives: To evaluate further aspects regarding the Dexcom G7 continuous glucose monitor system's performance in the intensive care unit (ICU), particularly in terms of sensitivity and specificity to detect hypo- and hyperglycaemic events, data availability, device deficiencies and safety. To identify predictive factors of the accuracy of the Dexcom G7 continuous glucose monitor system in critically ill patients in the ICU.

This clinical study explores whether adding technological tools during hospital discharge can help people with type 2 diabetes who are starting insulin therapy achieve better treatment adherence and blood glucose control once they return home. The discharge transition period includes both the final days of hospitalization and the first weeks to months after returning home. When people with type 2 diabetes are hospitalized, they sometimes need to begin insulin therapy. After discharge, managing insulin properly is essential to avoid high or low blood sugar levels. However, many patients forget or delay insulin doses, which can lead to poor control of their diabetes. This study will compare two groups of patients. All participants will be adults with type 2 diabetes, between 18 and 70 years old, who are newly starting insulin during their hospital stay. Group 1 ("technological group") will use a continuous glucose monitor (CGM) and a smart insulin pen cap called Insulclock. These tools show real-time blood glucose data and record when and how much insulin is injected. Patients and doctors can use this information to better adjust treatment. Insulclock also includes alarms to remind patients of their doses. Group 2 ("control group") will use the same devices, but they will not see the data in real time. Instead, they will manage their insulin based on standard finger-prick blood sugar checks four times a day, as typically done in standard care. Both groups will be followed for 12 weeks after hospital discharge. Medical check-ins will occur in weeks 1, 2, 4, 8, and 12. Blood tests and treatment adjustments will be performed as needed. The main goals are: To measure if the use of technology helps patients stick to their insulin schedule (fewer missed or mistimed injections). To see if it leads to better blood glucose control (e.g., more time within the recommended range, fewer episodes of low or high glucose). To evaluate patient satisfaction with this technology and check if the number of unplanned hospital readmissions decreases. The study will take place at Hospital Universitari i Politècnic La Fe in Valencia, Spain. Around 80 patients will participate. This study is important because real-world data about the use of CGM and smart insulin devices during the hospital-to-home transition are limited. It may help improve diabetes care for people starting insulin after hospitalization.