An interventional study of Simultanious CGM/FGM in Diabetes Mellitus Complication and Renal Impairment, sponsored by Vastra Gotaland Region. Completed at 1 site in Sweden. Open to participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Vastra Gotaland Region · Not applicable, Interventional, and Treatment
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The study aims to evaluate the accuracy of two commercial glucose monitoring systems in patients with type 1 or type 2 diabetes and renal impairment, including patients with or without dialysis. Patients treatment experience will even be evaluated.
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.
267 studies on the registry are indexed under Diabetes Complications; 54 are open to participants now.
This study's enrollment of 40 is below the median of 72 across 171 interventional studies indexed under Diabetes Complications.
Browse Diabetes Complications studies →Vastra Gotaland Region is the lead sponsor of 276 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: The whole study period Day 1-14
The evaluation of the accuracy of the 2 glucose monitoring systems during each studied time interval (day 1-3 and day 4-6)
The evaluation of the accuracy of the 2 glucose monitoring systems for various glucose intervals (hypo, normo- and hyperglycaemia)
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)
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.
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.
Time frame: The whole study period Day 1-14
Ran from May 2016 to primary completion in Dec 2019, 43 months.
Of 62 non-industry interventional studies with no phase under Diabetes Complications, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's 43 months is above that.
Counting every sponsor, half of 69 studies reached it within 28 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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