Accuracy and Treatment Experience of Two Glucose Monitoring Systems Tested in Patients With Type 1 Diabetes and Renal Impairment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03378271|
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : November 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Complication Renal Impairment||Device: Simultanious CGM/FGM||Not Applicable|
Continuous glucose monitoring (CGM) and Flash glucose monitoring (FGM) are tools today mainly used in the treatment of patients with type 1 diabetes. Both glucose monitors are subcutaneous tissue sensors, which provide a tissue fluid glucose measurement every 1 to 5 minutes. The real-time glucose sensor trend data can help patients with diabetes better manage their insulin needs with meals and exercise. The following glucose monitoring systems are two of the most current sensor technologies available for clinical use the Dexcom G5 (Dexcom Corporation), and the FGM (Abbot Freestyle Libre).
High glucose levels in patients with type 1 or 2-diabetes lead to increased risks of micro- and macrovascular complications, while low glucose levels may lead to unconsciousness. Therefore, it is important for patients to manage glucose levels as close to normal (4-7 mmol/l) as possible. This is generally performed by appropriate dosage of different insulins, calculated from the preprandial glucose level, carbohydrate intake, and physical activity. In spite of careful dosage, glucose levels often become too low or too high.
CGM is a novel tool to detect low and high glucose levels, and it is capable of sounding an alarm for low and high glucose levels. CGM has been available in clinical practice in Sweden for approximately 5 years. FGM is as CGM also a novel tool to detect low and high glucose levels, but is not capable of sounding an alarm for low and high glucose levels. FGM has been available in clinical practice in Sweden since late 2014.
Since both CGM and FGM measure the glucose level by a sensor in subcutaneous tissue, there is uncertainty in the estimation of blood glucose levels. The accuracy of a certain CGM or FGM system can be assessed by comparing the glucose levels estimated by the glucose monitors with measured glucose levels in capillary blood samples. To our knowledge there are no studies comparing the accuracy of the Dexcom G5 sensor with the Freestyle Libre sensor. In the current study, we will compare the accuracy and treatment experience of these two glucose monitoring sensors available on the market for clinical use in patients with type 1 or 2 diabetes and renal impairment with an eGFR<30 ml/min both in and not in dialysis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accuracy and Treatment Experience of Two Glucose Monitoring Systems Tested Simultaneously in Ambulatory Patients With Type 1 Diabetes and Renal Impairment|
|Actual Study Start Date :||May 5, 2016|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||December 31, 2020|
each patient will have a CGM and a FGM, subcutaneous glucose sensors, the data will be compared to the time-matched reference blood glucose measurements.
Each ambulatory patient will sample capillary blood with the HemoCue meter and measure the concentration of glucose minimum 3 times per day for 14 days. The concentration of finger-stick capillary blood glucose will be measured using the self-monitoring blood glucose (SMBG) hemocue meter in their daily living. The subjects will record SMBG, in a written diary. Subjects will dose insulin according to their routine methods throughout the 14 day study
Device: Simultanious CGM/FGM
Patients will use both CGM and FGM and document their values as well as documenting a capillary blood glucose value.
- Accuracy of CGM and FGM [ Time Frame: The whole study period Day 1-14 ]Evaluation of accuracy in estimating capillary glucose levels of two commercial glucose monitoring systems (CGM and FGM), Dexcom G5 system (Dexcom sensor) and the Abbot Freestyle Libre sensor, in ambulatory patients with type 1 or type 2 diabetes and renal impairment with an eGFR<30 ml/min both in and not in dialysis.
- The evaluation of the accuracy of the 2 glucose monitoring systems during each studied time interval (day 1-3 and day 4-6) [ Time Frame: Day 1-6 of study period ]The evaluation of the accuracy of the 2 glucose monitoring systems for various glucose intervals (hypo, normo- and hyperglycaemia)
- The evaluation of the accuracy of the 2 glucose monitoring systems for various glucose intervals (hypo, normo- and hyperglycaemia) [ Time Frame: The whole study period Day 1-14 ]
- The evaluation of the accuracy of the 2 glucose monitoring systems during dialysis and not in dialysis [ Time Frame: The whole study period Day 1-14 ]
- The evaluation of patients preferences and experience of the two glucose monitoring systems. [ Time Frame: The whole study period Day 1-14 ]Patients will answer questionnaires on both systems to see which system they prefer to use and find more user friendly. the questionnaire will be in the form of a Lickert scale from 0-10.
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): NCT03378271
|Contact: Arndís F Ólafsdóttir, PgDfirstname.lastname@example.org|
|Uddevalla, Sweden, 45180|
|Contact: Arndís Ólafsdóttir|
|Principal Investigator:||Marcus Lind, PhD||Gothenburgh University|