Diabetes Mellitus, Type 1NCT03613805
Eversense and Dexcom G5: Efficacy and Accuracy in Type 1 Diabetic Patients
A study testing Dexcom G5-Eversense and Eversense-Dexcom G5 in people with Diabetes Mellitus, Type 1, run by University of Padova at 1 site in Italy.
Trial summary
Continuous Glucose Monitoring (CGM) systems improve glycaemic control in type 1 diabetic patients but they have different characteristics that could influence patients' quality of life and glycaemic control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Dexcom G5-Eversense and Eversense-Dexcom G5
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 14 Mar 2018to 1 Sep 2019
- 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
- Male and female participants of at least 18 years of age
- Diagnosis of type 1 diabetes mellitus (diagnosed according to World Health Organization criteria) for at least 1 year
- Body Mass Index (BMI) <35 kg / m²
- Availability to wear study equipment and to comply with the study protocol for its entire duration
- HbA1c <10%
- Signature of informed consent before any procedure related to the study.
Who cannot join
- Pregnancy, breastfeeding, intention to undergo pregnancy or refusal to use contraceptive methods during the study period (for female subjects).
- Known allergies to skin patches or disinfectants used during the study.
- Skin lesions, irritation, redness, edema in sites where sensors can be applied, as this might interfere with sensor's placement or with the accuracy of the glycaemic value detection.
- Use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study period.
- Use of acetaminophen or other drugs that could influence sensor accuracy
- Severe medical or psychological conditions, which, in the opinion of the medical team, may compromise patients' safety while participating in the study.
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- Patients enrolled in other clinical trials.
- Known disorders of adrenal glands, pancreatic tumors or insulinoma
- Patient's inability to comply with the procedures of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eversense and Dexcom G5 Comparison in Real Life: a Randomized Crossover Trial in Type 1 Diabetic Patients to Evaluate Differences in Accuracy, Efficacy and Quality of Life
Continuous Glucose Monitoring (CGM) systems improve glycaemic control in type 1 diabetic patients but they have different characteristics that could influence patients' quality of life and glycaemic control.
In this randomized cross over study investigators will compare 2 different CGM systems: Eversense implantable sensor (Senseonics, Germantown, MD, USA) and the standard transcutaneous sensor Dexcom G5 (Dexcom, San Diego, CA, USA). Investigators will evaluate sensors' accuracy, impact on quality of life and efficacy in optimizing glycaemic control.
The investigator's study's results might help clinicians choose the sensor and evaluate how sensor differences could impact glycaemic control.
Read the detailed description
Good glycaemic control in type 1 diabetic patients prevents the onset and progression of chronic complications. Continuous Glucose Monitoring (CGM) systems help patients improve glycaemic control by providing real-time glucose levels, glycaemic tendency, glycaemic swing rate and by alerting the patient when the glucose value read by the sensor reaches a predefined threshold of hyper or hypoglycaemia.
Several CGM systems are available and they have different characteristics that could influence patients' quality of life and glycaemic control.
In this randomized cross over study investigators will compare 2 different CGM systems: Eversense implantable sensor (Senseonics, Germantown, MD, USA) and the standard transcutaneous sensor Dexcom G5 (Dexcom, San Diego, CA, USA). Investigators will evaluate sensors' accuracy, impact on quality of life and efficacy in optimizing glycaemic control.
Patients will use Dexcom G5 or Eversense for three months, respectively, in a randomized order. Accuracy will be evaluated comparing sensors values with capillary blood glucose at home.
Quality of life will be assessed at the beginning and at the end of each three-month period through validated questionnaires to underline differences in different sensors use.
Time spent in target (70-180 mg/dl), in hypoglycamiea and hyperglycemia will be evaluated with both sensors to assess differences in glycaemic control induced by different alarm system and by the presence of predictive alarms
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Dexcom G5-Eversense, Eversense-Dexcom G5
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G5-EversenseDevice
Patients will wear sensor for 3 months, monitor blood capillary values 4 times/day. At the beginning and at the end of the period HbA1c will be measured and questionnaires will be administered
Eversense-Dexcom G5Device
Patients will wear sensor for 3 months, monitor blood capillary values 4 times/day. At the beginning and at the end of the period HbA1c will be measured and questionnaires will be administered.
After 30-50 days of sensor implantation patients will wear also Dexcom G5 for a week to compare accuracy simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Dexcom G5 - Eversense | Active comparator | Patients will wear first Dexcom G5 (Dexcom San Diego, CA, USA) transcutaneous sensor for 3 months, then Eversnese(Senseonics Inc, MD, USA) implantable sensor for 3 months Accuracy and efficacy will be evaluated Receives: Device: Dexcom G5-Eversense |
| Eversense- Dexcom G5 | Experimental | Patients will wear first Eversense (Senseonics Inc, MD, USA) implantable sensor for 3 months, then Dexcom G5 (Dexcom San Diego, CA, USA) transcutaneous sensor for 3 months accuracy and efficacy will be evaluated Receives: Device: Eversense-Dexcom G5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
device accuracy
sensors' accuracy expressed in terms of MARD (mean absolute relative difference) versus capillary blood glucose in different glycaemic ranges
Measured: after 3 months, at the end of the study for each arm of the study
Secondary outcomes (6)
Time spent in target
% Time spent in target (70-180 mg/dl) using each sensor to evaluate sensor efficacy
Measured: after 3 months, at the end of the study for each arm of the study
HbA1c
HbA1c changes using different sensors, to evaluate sensor efficacy
Measured: after 3 months, at the end of the study for each arm of the study
failure
% Sensors' failure rate to evaluate sensor duration
Measured: after 3 months, at the end of the study for each arm of the study
Adverse events
Adverse events (skin reactions, haematomas)
Measured: after 3 months, at the end of the study for each arm of the study
changes in quality of life
DTSQ questionnaire
Measured: after 3 months, at the end of the study for each arm of the study
changes in fear of hypoglycaemia
HFSII questionnaire
Measured: after 3 months, at the end of the study for each arm of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start14 Mar 2018
- Primary completion31 Dec 2018
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Bruttomesso, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613805
- Sponsor's protocol ID
- 4270/AO/17
- Status last verified
- Mar 2020
- First submitted
- 26 Apr 2018
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eversense and Dexcom G5 Comparison in Real Life: a Randomized Crossover Trial in Type 1 Diabetic Patients to Evaluate Differences in Accuracy, Efficacy and Quality of Life
- ClinicalTrials.gov ID
- NCT03613805
- Acronym / sponsor ID
- 4270/AO/17
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 3 Aug 2018 (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.
Continuous Glucose Monitoring (CGM) systems improve glycaemic control in type 1 diabetic patients but they have different characteristics that could influence patients' quality of life and glycaemic control.
In this randomized cross over study investigators will compare 2 different CGM systems: Eversense implantable sensor (Senseonics, Germantown, MD, USA) and the standard transcutaneous sensor Dexcom G5 (Dexcom, San Diego, CA, USA). Investigators will evaluate sensors' accuracy, impact on quality of life and efficacy in optimizing glycaemic control.
The investigator's study's results might help clinicians choose the sensor and evaluate how sensor differences could impact glycaemic control.
Detailed description
Good glycaemic control in type 1 diabetic patients prevents the onset and progression of chronic complications. Continuous Glucose Monitoring (CGM) systems help patients improve glycaemic control by providing real-time glucose levels, glycaemic tendency, glycaemic swing rate and by alerting the patient when the glucose value read by the sensor reaches a predefined threshold of hyper or hypoglycaemia.
Several CGM systems are available and they have different characteristics that could influence patients' quality of life and glycaemic control.
In this randomized cross over study investigators will compare 2 different CGM systems: Eversense implantable sensor (Senseonics, Germantown, MD, USA) and the standard transcutaneous sensor Dexcom G5 (Dexcom, San Diego, CA, USA). Investigators will evaluate sensors' accuracy, impact on quality of life and efficacy in optimizing glycaemic control.
Patients will use Dexcom G5 or Eversense for three months, respectively, in a randomized order. Accuracy will be evaluated comparing sensors values with capillary blood glucose at home.
Quality of life will be assessed at the beginning and at the end of each three-month period through validated questionnaires to underline differences in different sensors use.
Time spent in target (70-180 mg/dl), in hypoglycamiea and hyperglycemia will be evaluated with both sensors to assess differences in glycaemic control induced by different alarm system and by the presence of predictive alarms
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexcom G5 - Eversense | Active comparator | Device: Dexcom G5-EversensePatients will wear first Dexcom G5 (Dexcom San Diego, CA, USA) transcutaneous sensor for 3 months, then Eversnese(Senseonics Inc, MD, USA) implantable sensor for 3 months Accuracy and efficacy will be evaluated |
| Eversense- Dexcom G5 | Experimental | Device: Eversense-Dexcom G5Patients will wear first Eversense (Senseonics Inc, MD, USA) implantable sensor for 3 months, then Dexcom G5 (Dexcom San Diego, CA, USA) transcutaneous sensor for 3 months accuracy and efficacy will be evaluated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female participants of at least 18 years of age
- Diagnosis of type 1 diabetes mellitus (diagnosed according to World Health Organization criteria) for at least 1 year
- Body Mass Index (BMI) <35 kg / m²
- Availability to wear study equipment and to comply with the study protocol for its entire duration
- HbA1c <10%
Key exclusion criteria (9 listed)
- Pregnancy, breastfeeding, intention to undergo pregnancy or refusal to use contraceptive methods during the study period (for female subjects).
- Known allergies to skin patches or disinfectants used during the study.
- Skin lesions, irritation, redness, edema in sites where sensors can be applied, as this might interfere with sensor's placement or with the accuracy of the glycaemic value detection.
- Use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study period.
- Use of acetaminophen or other drugs that could influence sensor accuracy
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 |
|---|---|---|
| Dexcom G5-EversensePatients will wear sensor for 3 months, monitor blood capillary values 4 times/day. At the beginning and at the end of the period HbA1c will be measured and questionnaires will be administered | Device | Dexcom G5 - Eversense |
| Eversense-Dexcom G5Patients will wear sensor for 3 months, monitor blood capillary values 4 times/day. At the beginning and at the end of the period HbA1c will be measured and questionnaires will be administered. After 30-50 days of sensor implantation patients will wear also Dexcom G5 for a week to compare accuracy simultaneously | Device | Eversense- Dexcom G5 |
Primary outcome
device accuracy
Time frame: after 3 months, at the end of the study for each arm of the study
sensors' accuracy expressed in terms of MARD (mean absolute relative difference) versus capillary blood glucose in different glycaemic ranges
6 secondary outcomes
Time spent in target
Time frame: after 3 months, at the end of the study for each arm of the study
HbA1c
Time frame: after 3 months, at the end of the study for each arm of the study
failure
Time frame: after 3 months, at the end of the study for each arm of the study
Adverse events
Time frame: after 3 months, at the end of the study for each arm of the study
changes in quality of life
Time frame: after 3 months, at the end of the study for each arm of the study
changes in fear of hypoglycaemia
Time frame: after 3 months, at the end of the study for each arm of the study
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 27 Mar 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom G5-Eversense and Eversense-Dexcom G5 in people with Diabetes Mellitus, Type 1, run by University of Padova at 1 site in Italy.
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 6 inclusion and 9 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 27 Mar 2020. 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 Italy. 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?
device accuracy (time frame: after 3 months, at the end of the study for each arm of the study). 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 27 Mar 2020.