Type 1 DiabetesNCT01714895
Effect of Different Plasma Insulin Levels on the Accuracy of Continuous Subcutaneous Glucose Monitoring
A study testing High insulin eu-hypoglycemic clamp and Low insulin eu-hypoglycemic clamp in people with Type 1 Diabetes and Continuous Glucose Monitoring, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial summary
Achieving near-normoglycaemia has been established as the main objective for most patients with diabetes. However, it is well known that intensification of treatment is associated with an increase in the frequency of hypoglycemia, especially in the context of insulin therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 1 Diabetes, Continuous Glucose Monitoring, Hypoglycemia
- What is being tested?
- High insulin eu-hypoglycemic clamp and Low insulin eu-hypoglycemic clamp
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2011to Oct 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects with type 1 diabetes mellitus meeting all of the following criteria will be considered for admission to the study:
- Aged between 18 and 60 years
- Under CSII or MDI treatment for at least six months before Visit 1
- Body mass index of between 18 and 30 kg/m2
- HbA1c 6.0-8.5% at Visit 1
- Normal laboratory values, ECG, and vital signs unless the investigator considered an abnormality to be clinically irrelevant
- Women postmenopausal or using contraception judged by the investigator to be adequate (e.g., oral contraceptives, intra-uterine device or surgical treatment)
Who cannot join
- Subjects meeting any of the following criteria will not be included in the study:
- Pregnancy and lactation
- History of hypersensitivity to the study medications or to drugs with similar chemical structures
- Confirmed hypoglycaemia unawareness
- Progressive fatal diseases
- History of drug or alcohol abuse
Show all 15Show fewer
- History of positive HIV or hepatitis B or C test
- Impaired hepatic function, as shown by, but not limited to, SGPT or SGOT of more than twice the upper limit of the normal range at visit 1
- Impaired renal function, as shown by, but not limited to, serum creatinine > 1.5 mg/dL at visit 1
- Clinically relevant microvascular, cardiovascular, hepatic, neurologic, endocrine or other major systemic diseases other than T1DM which could hinder implementation of the clinical study protocol or interpretation of the study results
- Pre-planned surgery during the study
- Blood donation of more than 500 ml during the past three months for men, or during the past six months for women
- Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- Subject unlikely to comply with clinical study protocol, e.g., uncooperative attitude, inability to return for follow-up visits, or poor likelihood of completing the study
- Receipt of an experimental drug or use of an experimental device during the past 30 days.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valencia
Valencia, 46010
About this study
Official title: New Strategies for Automated Glycaemic Control: the Issue of Continuous Glucose Monitoring Accuracy Under Hypoglycaemic Conditions
Achieving near-normoglycaemia has been established as the main objective for most patients with diabetes. However, it is well known that intensification of treatment is associated with an increase in the frequency of hypoglycemia, especially in the context of insulin therapy. The burden of hypoglycemia in terms of psychological implications, morbidity and even mortality, explains why it has been defined as the main limiting factor to achievement of good metabolic control.
Continuous subcutaneous glucose monitoring (CGM) devices have been claimed to be useful in hypoglycemia detection/prevention, allowing theoretically for safer intensification of therapy in diabetic patients. However, accuracy of CGM devices, especially in the hypoglycemic range, raises some concerns. In fact, commercially available CGM devices estimate plasma glucose from measurements in the interstitial fluid and not in plasma. However, the relationship between plasma and interstitial glucose is not fully understood, especially under dynamic conditions, and this may explain the poor CGM performance during rapid changes in blood glucose and hypoglycemia.
Read more
In this project, the relationship between plasma and interstitial glucose will be evaluated under conditions of normal glucose concentrations and hypoglycemia. Experiments will be performed to assess the role, if any, of different plasma insulin concentrations on the accuracy of CGM.
All the information obtained may be relevant to the improvement of the ability of CGM devices to detect hypoglycemia and hypoglycemic risk.
- Conditions
- Type 1 Diabetes, Continuous Glucose Monitoring, Hypoglycemia
- Being tested
- High insulin eu-hypoglycemic clamp, Low insulin eu-hypoglycemic clamp
- Keywords
- Interstitial glucose dynamics, Accuracy of continuous glucose monitoring under hypoglycemia, Glucose clamp
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High insulin eu-hypoglycemic clampOther
Primed intravenous insulin infusion at a rate of 1mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms.
Low insulin eu-hypoglycemic clampOther
Primed intravenous insulin infusion at a rate of 0.3mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms.
| Study group | Role | What they receive |
|---|---|---|
| High plasma insulin-Low plasma insulin | Other | Seven out of the 14 subjects recruited in the study have been randomized to receive on the first study day a High insulin glucose clamp and on the second day a Low insulin glucose clamp (sequence 'AB') Receives: Other: High insulin eu-hypoglycemic clamp; Other: Low insulin eu-hypoglycemic clamp |
| Low plasma insulin-High plasma insulin | Other | Seven out of the 14 subjects recruited in the study have been randomized to receive on the first study day a Low insulin glucose clamp and on the second day a High insulin glucose clamp (sequence 'BA') Receives: Other: High insulin eu-hypoglycemic clamp; Other: Low insulin eu-hypoglycemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalized current signal from the CGM devices
CGM devices are electrochemical sensors. Currently available sensors are placed in the subcutaneous tissue where they react with the glucose of the interstitial fluid giving a current signal (in nano Amperes), which is proportional to glucose concentrations. The current signal is then filtered and transformed into plasma glucose estimations through a calibration algorithm built into the CGM device.
In this study we will analyze the current signal from CGM obtained under two different experimental conditions:
- Eu-hypoglycemic clamp with High plasma insulin concentrations
- Eu-hypoglycemic clamp with relatively Low plasma insulin concentrations
This will allow for establishing the role, if any, of different plasma insulin concentrations on the accuracy of CGM to identify plasma glucose falls resulting in hypoglycaemia.
Since CGM sensors can exhibit different sensitivities to glucose concentrations, the current signal will be normalized before statistical analysis
Measured: 330 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionOct 2012
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 Type 1 DiabetesStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de València
- Responsible party
- Sponsor
- Investigators
- Francisco Javier Ampudia-Blasco, MD, PhD, Principal investigator, Hospital Clínico Universitario de Valencia - Fundación INCLIVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714895
- Sponsor's protocol ID
- FP7-PEOPLE-2009-IEF #252085-2
- Other IDs
- Spanish Ministry of Science
- Status last verified
- Oct 2012
- First submitted
- 24 Oct 2012
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Moscardo V, Bondia J, Ampudia-Blasco FJ, Fanelli CG, Lucidi P, Rossetti P. Plasma Insulin Levels and Hypoglycemia Affect Subcutaneous Interstitial Glucose Concentration. Diabetes Technol Ther. 2018 Apr;20(4):263-273. doi: 10.1089/dia.2017.0219. Epub 2018 Mar 12.
PubMed 29638161
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Strategies for Automated Glycaemic Control: the Issue of Continuous Glucose Monitoring Accuracy Under Hypoglycaemic Conditions
- ClinicalTrials.gov ID
- NCT01714895
- Acronym / sponsor ID
- FP7-PEOPLE-2009-IEF #252085-2
- Conditions
- Type 1 Diabetes, Continuous Glucose Monitoring, Hypoglycemia
- Keywords
- Interstitial glucose dynamics, Accuracy of continuous glucose monitoring under hypoglycemia, Glucose clamp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Collaborators
- Universitat Politècnica de València
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 26 Oct 2012 (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.
Achieving near-normoglycaemia has been established as the main objective for most patients with diabetes. However, it is well known that intensification of treatment is associated with an increase in the frequency of hypoglycemia, especially in the context of insulin therapy. The burden of hypoglycemia in terms of psychological implications, morbidity and even mortality, explains why it has been defined as the main limiting factor to achievement of good metabolic control.
Continuous subcutaneous glucose monitoring (CGM) devices have been claimed to be useful in hypoglycemia detection/prevention, allowing theoretically for safer intensification of therapy in diabetic patients. However, accuracy of CGM devices, especially in the hypoglycemic range, raises some concerns. In fact, commercially available CGM devices estimate plasma glucose from measurements in the interstitial fluid and not in plasma. However, the relationship between plasma and interstitial glucose is not fully understood, especially under dynamic conditions, and this may explain the poor CGM performance during rapid changes in blood glucose and hypoglycemia.
In this project, the relationship between plasma and interstitial glucose will be evaluated under conditions of normal glucose concentrations and hypoglycemia. Experiments will be performed to assess the role, if any, of different plasma insulin concentrations on the accuracy of CGM.
All the information obtained may be relevant to the improvement of the ability of CGM devices to detect hypoglycemia and hypoglycemic risk.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High plasma insulin-Low plasma insulin | Other | Other: High insulin eu-hypoglycemic clamp, Other: Low insulin eu-hypoglycemic clampSeven out of the 14 subjects recruited in the study have been randomized to receive on the first study day a High insulin glucose clamp and on the second day a Low insulin glucose clamp (sequence 'AB') |
| Low plasma insulin-High plasma insulin | Other | Other: High insulin eu-hypoglycemic clamp, Other: Low insulin eu-hypoglycemic clampSeven out of the 14 subjects recruited in the study have been randomized to receive on the first study day a Low insulin glucose clamp and on the second day a High insulin glucose clamp (sequence 'BA') |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects with type 1 diabetes mellitus meeting all of the following criteria will be considered for admission to the study:
Key exclusion criteria (15 listed)
- Subjects meeting any of the following criteria will not be included in the study:
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 |
|---|---|---|
| High insulin eu-hypoglycemic clampPrimed intravenous insulin infusion at a rate of 1mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms. | Other | High plasma insulin-Low plasma insulin, Low plasma insulin-High plasma insulin |
| Low insulin eu-hypoglycemic clampPrimed intravenous insulin infusion at a rate of 0.3mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms. | Other | High plasma insulin-Low plasma insulin, Low plasma insulin-High plasma insulin |
Primary outcome
Normalized current signal from the CGM devices
Time frame: 330 minutes
CGM devices are electrochemical sensors. Currently available sensors are placed in the subcutaneous tissue where they react with the glucose of the interstitial fluid giving a current signal (in nano Amperes), which is proportional to glucose concentrations. The current signal is then filtered and transformed into plasma glucose estimations through a calibration algorithm built into the CGM device. In this study we will analyze the current signal from CGM obtained under two different experimental conditions: 1. Eu-hypoglycemic clamp with High plasma insulin concentrations 2. Eu-hypoglycemic clamp with relatively Low plasma insulin concentrations This will allow for establishing the role, if any, of different plasma insulin concentrations on the accuracy of CGM to identify plasma glucose falls resulting in hypoglycaemia. Since CGM sensors can exhibit different sensitivities to glucose concentrations, the current signal will be normalized before statistical analysis
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 26 Oct 2012.
- Derived from this study: PubMed 29638161Moscardo V, Bondia J, Ampudia-Blasco FJ, Fanelli CG, Lucidi P, Rossetti P. Plasma Insulin Levels and Hypoglycemia Affect Subcutaneous Interstitial Glucose Concentration. Diabetes Technol Ther. 2018 Apr;20(4):263-273. doi: 10.1089/dia.2017.0219. Epub 2018 Mar 12.
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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.
Francisco Javier Ampudia-Blasco, MD, PhD principal investigator
Hospital Clínico Universitario de Valencia - Fundación INCLIVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High insulin eu-hypoglycemic clamp and Low insulin eu-hypoglycemic clamp in people with Type 1 Diabetes and Continuous Glucose Monitoring, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
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 7 inclusion and 15 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 26 Oct 2012. 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 Spain. 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?
Normalized current signal from the CGM devices (time frame: 330 minutes). 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 NCT01714895, 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 26 Oct 2012.