Diabetes Mellitus, Type 1NCT02159638
Accuracy of Two CGM Systems Tested Simultaneously in Ambulatory Patients With Type 1 Diabetes
A study testing Guardian Enlite sensor and Dexcom G4 platinum sensor in people with Diabetes Mellitus, Type 1 and Blood Glucose, run by Vastra Gotaland Region at 2 sites in Sweden.
Trial summary
Continuous glucose monitoring (CGM) is a tool used in the treatment of patients with type 1 diabetes. A continuous glucose monitor (CGM) is a subcutaneous tissue sensor, which provides a tissue fluid glucose measurement every 1 to 5 minutes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Blood Glucose
- What is being tested?
- Guardian Enlite sensor and Dexcom G4 platinum sensor
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesSweden
- Study dates
- May 2013to 1 Sep 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Adult patients, age 18 or older and <75 years.
- Written Informed Consent
Who cannot join
- Pregnancy
- Patients with severe cognitive dysfunction or other disease which makes CGM 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 DexCom4G. However, other pain
- killers can be used throughout the study period.
Show all 14Show fewer
- Current CGM use
- History of allergic reaction to any of the CGMS 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).
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
NU-hospital Organisation
Trollhättan, 46173
Uddevalla hospital
Uddevalla, 45180
About this study
Continuous glucose monitoring (CGM) is a tool used in the treatment of patients with type 1 diabetes. A continuous glucose monitor (CGM) is a subcutaneous tissue sensor, which provides a tissue fluid glucose measurement every 1 to 5 minutes. Since CGM 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 system can be assessed by comparing the glucose levels estimated by CGM with measured glucose levels in plasma. In the current study, we will compare the accuracy of the 2 CGM systems available on the market for clinical use in patients with type 1 diabetes. The aim of the current study is to evaluate effectiveness, safety and treatment satisfaction with 2 different CGM systems among adult type 1 diabetic patients.
Read the detailed description
Each study patient will have both subcutaneous tissue CGM sensors inserted. Each sensor will produce a maximum of 1,440 tissue fluid glucose measurements per 24 hours and 8,460 measurements during the 6 days in study. The plan is to study 36 to 50 ambulatory patients during the hole study period. The two CGM data sets (DexCom4G and Medtronic Enlite) will be compared to each other and the time-matched reference blood glucose measurements.
The HemoCue Analyser- venous blood and finger-stick blood in cuvette, will be used to measure the concentration of glucose.
Each ambulatory patient will sample capillary blood and measure the concentration of glucose 6 to 10 times per day for max 6 days. The concentration of finger-stick capillary blood glucose will be measured using the HemoCue meter in their daily living and additionally a HemoCue Analyser at research visits using a lancet. Each patient will be admitted to the clinical research unit (CRU) for 7 measurements of venous samples at two occasions: on day 1-3 and 4-6 of the study with an interval of at least 15 minutes. An intravenous catheter will be inserted to facilitate blood sample acquisition each of these days of study. Three capillary finger-stick blood will be sampled at these 2 occasions, 1 at the first venous measurement (one day of days 1-3) and one at the last venous sample (one day of days 4-6).
Blood sample acquisition and handling will be standardized to minimize pre-analytical error.
The sensor insertion sites will be observed to detect bleeding, inflammation and infection of the skin or subcutaneous tissue. Insertion sites will be photographed if any abnormal findings exist at the end of the study for the individual patient.
The subjects will record self monitoring of blood glucose (SMBG), meal, and activity data in a written diary.
- Conditions
- Diabetes Mellitus, Type 1, Blood Glucose
- Being tested
- Guardian Enlite sensor, Dexcom G4 platinum sensor
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin-Dependent, Endocrine System Diseases, Blood glucose, Blood Glucose, Self-Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guardian Enlite sensorDevice
Sensor insertion
Dexcom G4 platinum sensorDevice
Sensor insertion
| Study group | Role | What they receive |
|---|---|---|
| comparisson CGM accuracy | Other | Each patient will have both subcutaneous tissue CGM sensors (Guardian Enlite sensor and Dexcom G4 Platinum sensor) inserted at the same time. The HemoCue Analyser- venous blood and finger-stick blood in cuvette, will be used to measure the concentration of glucose Receives: Device: Guardian Enlite sensor; Device: Dexcom G4 platinum sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the two CGM systems compared to capillary glucose value
Primary efficacy analysis will be investigating whether there is a statistically significant difference between the two CGM systems with respect to mean absolute relative difference (MARD) of estimated capillary glucose value over the whole study period.
Measured: 6 days
Secondary outcomes (5)
the accuracy of the 2 CGM systems during each studied time interval (day 1-3 and day 4-6)
Accuracy of all estimated capillary glucose values (registered both during days 1-3 and days 4-6) of DexCom 4G system (DexCom sensor) vs Guardian Real-Time system (Enlite sensor) system compared to the capillary reference blood glucose measured with HemoCue.
Measured: day 1-3 and day 4-6
the accuracy of the 2 CGM systems for hypoglycaemia
Accuracy in estimating capillary glucose levels <4 registered both during days 1-3 and days 4-6 of DexCom 4G system (DexCom sensor) vs Guardian Real-Time system (Enlite sensor) system compared to the capillary reference blood glucose measured with HemoCue(hypo, normoglycaemia and hyperglycaemia)
Measured: 6 days
the accuracy of the 2 CGM systems for normoglycaemia
Accuracy in estimating capillary glucose levels of 4.0-10.0 mmol/l registered both during days 1-3 and days 4-6 of DexCom 4G system (DexCom sensor) vs Guardian Real-Time system (Enlite sensor) system compared to the capillary reference blood glucose measured with HemoCue
Measured: 6 days
the accuracy of the 2 CGM systems for hyperglycaemia
Accuracy in estimating capillary glucose levels >14.0 mmol/l registered both during days 1-3 and days 4-6 of DexCom 4G system (DexCom sensor) vs Guardian Real-Time system (Enlite sensor) system compared to the capillary reference blood glucose measured with HemoCue
Measured: 6 days
Evaluation of two CGM systems from questionnaire
Evaluation of DexCom 4G system (DexCom sensor) vs Guardian Real-Time system (Enlite sensor) from questionnaire
Measured: day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startMay 2013
- Primary completion1 Jul 2014
- Study completion1 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02159638
- Sponsor's protocol ID
- VGFOUREG-387191
- Status last verified
- Jun 2014
- First submitted
- 5 Jun 2014
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Matuleviciene V, Joseph JI, Andelin M, Hirsch IB, Attvall S, Pivodic A, Dahlqvist S, Klonoff D, Haraldsson B, Lind M. A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with type 1 diabetes. Diabetes Technol Ther. 2014 Nov;16(11):759-67. doi: 10.1089/dia.2014.0238. Epub 2014 Sep 18.
PubMed 25233297
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Two CGM Systems Tested Simultaneously in Ambulatory Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02159638
- Acronym / sponsor ID
- VGFOUREG-387191
- Conditions
- Diabetes Mellitus, Type 1, Blood Glucose
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin-Dependent, Endocrine System Diseases, Blood glucose, Blood Glucose, Self-Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- May 2013
- Primary completion
- 1 Jul 2014 (actual)
- Study completion
- 1 Sep 2014 (actual)
- First posted
- 10 Jun 2014 (estimated)
- 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.
Continuous glucose monitoring (CGM) is a tool used in the treatment of patients with type 1 diabetes. A continuous glucose monitor (CGM) is a subcutaneous tissue sensor, which provides a tissue fluid glucose measurement every 1 to 5 minutes. Since CGM 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 system can be assessed by comparing the glucose levels estimated by CGM with measured glucose levels in plasma. In the current study, we will compare the accuracy of the 2 CGM systems available on the market for clinical use in patients with type 1 diabetes. The aim of the current study is to evaluate effectiveness, safety and treatment satisfaction with 2 different CGM systems among adult type 1 diabetic patients.
Detailed description
Each study patient will have both subcutaneous tissue CGM sensors inserted. Each sensor will produce a maximum of 1,440 tissue fluid glucose measurements per 24 hours and 8,460 measurements during the 6 days in study. The plan is to study 36 to 50 ambulatory patients during the hole study period. The two CGM data sets (DexCom4G and Medtronic Enlite) will be compared to each other and the time-matched reference blood glucose measurements.
The HemoCue Analyser- venous blood and finger-stick blood in cuvette, will be used to measure the concentration of glucose.
Each ambulatory patient will sample capillary blood and measure the concentration of glucose 6 to 10 times per day for max 6 days. The concentration of finger-stick capillary blood glucose will be measured using the HemoCue meter in their daily living and additionally a HemoCue Analyser at research visits using a lancet. Each patient will be admitted to the clinical research unit (CRU) for 7 measurements of venous samples at two occasions: on day 1-3 and 4-6 of the study with an interval of at least 15 minutes. An intravenous catheter will be inserted to facilitate blood sample acquisition each of these days of study. Three capillary finger-stick blood will be sampled at these 2 occasions, 1 at the first venous measurement (one day of days 1-3) and one at the last venous sample (one day of days 4-6).
Blood sample acquisition and handling will be standardized to minimize pre-analytical error.
The sensor insertion sites will be observed to detect bleeding, inflammation and infection of the skin or subcutaneous tissue. Insertion sites will be photographed if any abnormal findings exist at the end of the study for the individual patient.
The subjects will record self monitoring of blood glucose (SMBG), meal, and activity data in a written diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| comparisson CGM accuracy | Other | Device: Guardian Enlite sensor, Device: Dexcom G4 platinum sensorEach patient will have both subcutaneous tissue CGM sensors (Guardian Enlite sensor and Dexcom G4 Platinum sensor) inserted at the same time. The HemoCue Analyser- venous blood and finger-stick blood in cuvette, will be used to measure the concentration of glucose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 diabetes
- Adult patients, age 18 or older and <75 years.
- Written Informed Consent
Key exclusion criteria (14 listed)
- Pregnancy
- Patients with severe cognitive dysfunction or other disease which makes CGM 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 DexCom4G. However, other pain
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 |
|---|---|---|
| Guardian Enlite sensorSensor insertion | Device | comparisson CGM accuracy |
| Dexcom G4 platinum sensorSensor insertion | Device | comparisson CGM accuracy |
Primary outcome
Difference between the two CGM systems compared to capillary glucose value
Time frame: 6 days
Primary efficacy analysis will be investigating whether there is a statistically significant difference between the two CGM systems with respect to mean absolute relative difference (MARD) of estimated capillary glucose value over the whole study period.
5 secondary outcomes
the accuracy of the 2 CGM systems during each studied time interval (day 1-3 and day 4-6)
Time frame: day 1-3 and day 4-6
the accuracy of the 2 CGM systems for hypoglycaemia
Time frame: 6 days
the accuracy of the 2 CGM systems for normoglycaemia
Time frame: 6 days
the accuracy of the 2 CGM systems for hyperglycaemia
Time frame: 6 days
Evaluation of two CGM systems from questionnaire
Time frame: day 6
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 19 Dec 2017.
- Derived from this study: PubMed 25233297Matuleviciene V, Joseph JI, Andelin M, Hirsch IB, Attvall S, Pivodic A, Dahlqvist S, Klonoff D, Haraldsson B, Lind M. A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with type 1 diabetes. Diabetes Technol Ther. 2014 Nov;16(11):759-67. doi: 10.1089/dia.2014.0238. Epub 2014 Sep 18.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guardian Enlite sensor and Dexcom G4 platinum sensor in people with Diabetes Mellitus, Type 1 and Blood Glucose, run by Vastra Gotaland Region at 2 sites 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 14 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 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Difference between the two CGM systems compared to capillary glucose value (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02159638, which also lists 1 linked publication.
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 19 Dec 2017.