Diabetes Mellitus ComplicationNCT03378271
Accuracy and Treatment Experience of Two Glucose Monitoring Systems Tested in Patients With Type 1 Diabetes and Renal Impairment
A study testing Simultanious CGM/FGM in people with Diabetes Mellitus Complication and Renal Impairment, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Diabetes Mellitus Complication, Renal Impairment
- What is being tested?
- Simultanious CGM/FGM
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 5 May 2016to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy and Treatment Experience of Two Glucose Monitoring Systems Tested Simultaneously in Ambulatory Patients With Type 1 Diabetes and Renal Impairment
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.
Read the 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.
- Conditions
- Diabetes Mellitus Complication, Renal Impairment
- Being tested
- Simultanious CGM/FGM
- Keywords
- Continuous Glucose Monitoring, Flash glucose Monitoring, Renal Impairment, Type 1 Diabetes, Type 2 Diabetes
- Medical subject headings
- Diabetes Complications, Renal Insufficiency, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultanious CGM/FGMDevice
Patients will use both CGM and FGM and document their values as well as documenting a capillary blood glucose value.
| Study group | Role | What they receive |
|---|---|---|
| FGM/CGM | Experimental | 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 Receives: Device: Simultanious CGM/FGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The whole study period Day 1-14
Secondary outcomes (4)
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)
Measured: 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)
Measured: The whole study period Day 1-14
The evaluation of the accuracy of the 2 glucose monitoring systems during dialysis and not in dialysis
Measured: 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.
Measured: The whole study period Day 1-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start5 May 2016
- Primary completion30 Dec 2019
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus ComplicationStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marcus Lind, PhD, Principal investigator, Gothenburgh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03378271
- Sponsor's protocol ID
- CGM renal impairment
- Status last verified
- Feb 2024
- First submitted
- 11 Dec 2017
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Treatment Experience of Two Glucose Monitoring Systems Tested Simultaneously in Ambulatory Patients With Type 1 Diabetes and Renal Impairment
- ClinicalTrials.gov ID
- NCT03378271
- Acronym / sponsor ID
- CGM renal impairment
- Conditions
- Diabetes Mellitus Complication, Renal Impairment
- Keywords
- Continuous Glucose Monitoring, Flash glucose Monitoring, Renal Impairment, Type 1 Diabetes, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 5 May 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FGM/CGM | Experimental | Device: Simultanious CGM/FGMeach 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultanious CGM/FGMPatients will use both CGM and FGM and document their values as well as documenting a capillary blood glucose value. | Device | FGM/CGM |
Primary outcome
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.
4 secondary outcomes
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Lind, PhD principal investigator
Gothenburgh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simultanious CGM/FGM in people with Diabetes Mellitus Complication and Renal Impairment, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of CGM and FGM (time frame: The whole study period Day 1-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.