- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03378271
Accuracy and Treatment Experience of Two Glucose Monitoring Systems Tested in Patients With Type 1 Diabetes and Renal Impairment
Accuracy and Treatment Experience of Two Glucose Monitoring Systems Tested Simultaneously in Ambulatory Patients With Type 1 Diabetes and Renal Impairment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Uddevalla, Sweden, 45180
- NU-Hospital Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Type 1 or type 2 diabetes with renal impairment and eGFR <30 ml/min measured within the last three months.
- Adult patients, age 18 or older and <80 years.
- Written Informed Consent
Exclusion criteria:
- Pregnancy
- Patients with severe cognitive dysfunction or other disease which makes glucose monitoring use difficult.
- Patients requiring continuous use of paracetamol. Paracetamol must not have been used the week before the study and shall not be used during the duration because it disturbs the interpretation of blood glucose levels estimated by the Dexcom G5. However, other pain killers can be used throughout the study period.
- Current CGM or FGM use.
- History of allergic reaction to any of the CGM or FGM materials or adhesives in contact with the skin.
- History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
- Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
- Patients with renal impairment and eGFR greater or equal to 30 ml/min estimated by the MDRD formula.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: FGM/CGM
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 |
Patients will use both CGM and FGM and document their values as well as documenting a capillary blood glucose value.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of CGM and FGM
Time Frame: The whole study period Day 1-14
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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.
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The whole study period Day 1-14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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The evaluation of the accuracy of the 2 glucose monitoring systems for various glucose intervals (hypo, normo- and hyperglycaemia)
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Day 1-6 of study period
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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
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The whole study period Day 1-14
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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
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The whole study period Day 1-14
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The evaluation of patients preferences and experience of the two glucose monitoring systems.
Time Frame: The whole study period Day 1-14
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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.
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The whole study period Day 1-14
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marcus Lind, PhD, Gothenburgh University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Immune System Diseases
- Autoimmune Diseases
- Kidney Diseases
- Urologic Diseases
- Endocrine System Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 1
- Renal Insufficiency
- Diabetes Complications
Other Study ID Numbers
- CGM renal impairment
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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