DiabetesDIAMOND-1NCT01369823
Diabetes Multicenter Observational Study (DIAMOND-1-)
An observational study of Diabetes, run by Medtronic Hellas Medical Devices ΑEE.
Trial summary
The purpose of this study is to examine whether pump treatment combined with the use of continuous glucose monitoring system is a mena to normalize glycaemic control. Read more about this study
- Who is it for?
- Ages 12 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Dec 2011
- Phase
- Observational
- 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 12 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: This is an observational pilot study that does not have a statistically powered primary hypothesis. The data collected during this study are for the purpose of accumulating information that may generate research ideas and lead to publications. For this reason a sample size of 100 subjects has been defined. The statistical analysis will be descriptive statistics and will be described in a separate statistical analysis plan. Moreover any enrolled patient that has a sensor usage % in the end of the study that is less than 65% will be excluded from the analysis.
Who may be able to join
- Subjects and/or their legal representative must sign the Patient Data Release Form (PDRF).
- Subjects must be aged between 12 and 45 years old.
- Subjects must be pump and Self- Monitoring Blood Glucose fingersticks users for at least 3 months and no more than 9 months.
- HbA1c >7.0% with a measurement no older than three months prior to enrollment.
- Diagnosed T1D at least 1 year before study entry.
- Subjects must be able to understand how to use the Paradigm REAL-Time System and how to adjust and administer corrective treatment.
- Subjects should not have used the sensor in the past.
Who cannot join
- Hearing or vision impairment so that alarms can not be recognized.
- Alcohol or drug abuse other than nicotine.
- Subjects suffering from severe chronic disease or genetic disorder other than T1D. (i.e. Down syndrome etc.)
- Subjects suffering from allergy.
- Subjects in pregnancy or with desire to conceive during study.
- Subjects participating in other device or drug studies.
About this study
Official title: Prospective, Multicenter, Non-interventional Post Market Release Study , to Examine Whether Pump Treatment Combined With the Use of Continuous Glucose Monitoring System is a Mean to Normalize Glycaemic Control.
The purpose of this study is to examine whether pump treatment combined with the use of continuous glucose monitoring system is a mena to normalize glycaemic control.
Read the detailed description
In this study, 100 subjects, users of Paradigm 522/722 Infusion Pump and Self- Monitoring Blood Glucose finger sticks for the control of their glucose levels for at least 3 months prior enrollment will participate. Moreover the subjects won't have achieved the best blood glucose control, with an average HbA1c above 7% and should meet all the inclusion and none of the exclusion criteria. The HbA1c value for screening purposes can be taken from the medical chart, while in the enrollment visit according to current medical practice of each investigational center, the sample taken for HbA1c measurement will be analyzed centrally by HPLC, in a lab in Germany. In all enrolled patients a continuous glucose monitoring system will be provided. Since this is an observational study, the provision of the glucose monitoring system will be based on medical justification and will not be done per protocol requirement. All subjects will be followed for 3 months according to the current medical practice of each investigational center. All other visits, e.g. patient comes into the hospital because of symptoms, will also be recorded as unscheduled visits. These visits are usually linked to Adverse Events.
- Conditions
- Diabetes
- Keywords
- HbA1c, Paradigm 522/722 Infusion Pump, Transmitter (MMT-7703WW), Sensor MMT-7002 (i.e. Glucose Sensor), Levels of HbA1c at enrollment higher than 7
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
The levels of HbA1c will be investigated on patients combining the pump therapy with continuous glucose monitoring over a period of three months.
Measured: 2 years
Secondary outcomes (8)
To evaluate the impact of continuous sensing on the variability of glucose
Measured: 2 years
To examine the frequency of hypoglycemic events.
Measured: 2 years
To examine the frequency of ketoacidosis events
Measured: 2 years
To examine the frequency of Emergency Department visits
Measured: 2 years
To examine the frequency of hospitalizations
Measured: 2 years
To examine the duration of hospitalizations
Measured: 2 years
To evaluate the daily insulin requirements
Measured: 2 years
To evaluate the % sensor usage
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJun 2009
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Hellas Medical Devices ΑEE
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Charalampos Vasilopoulos, Dr., Principal investigator, General Hospital of Athens "Evaggelismos"Christos Zoupas, Dr., Principal investigator, Diagnostic and Therapeutic Center of Athens "Hygeia"Marriana Benroubi, Dr., Principal investigator, General Hospital of Athens "POLICLINIC"Christina Kanaka, Dr., Principal investigator, Children General Hospital " Agia Sofia"Nikolaos Tentolouris, Dr., Principal investigator, General Hospital of Athens "LAIKO"Maria Alevizaki, Assoc. Prof., Principal investigator, General Hospital of Athens "ALEXANDRA"Andrianni Gerasimidi, Dr., Principal investigator, Children Hospital "Aglaia Kiriakou"Andreas Melidonis, Dr., Principal investigator, General Hospital of Peiraeus "TZANEIO"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369823
- Sponsor's protocol ID
- Version 1.0 - 12/Sep/2008
- Acronym
- DIAMOND-1
- Status last verified
- Jun 2011
- First submitted
- 7 Jun 2011
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Non-interventional Post Market Release Study , to Examine Whether Pump Treatment Combined With the Use of Continuous Glucose Monitoring System is a Mean to Normalize Glycaemic Control.
- ClinicalTrials.gov ID
- NCT01369823
- Acronym / sponsor ID
- DIAMOND-1 / Version 1.0 - 12/Sep/2008
- Conditions
- Diabetes
- Keywords
- HbA1c, Paradigm 522/722 Infusion Pump, Transmitter (MMT-7703WW), Sensor MMT-7002 (i.e. Glucose Sensor), Levels of HbA1c at enrollment higher than 7
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medtronic Hellas Medical Devices ΑEEIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Study completion
- Dec 2011 (estimated)
- First posted
- 9 Jun 2011 (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.
The purpose of this study is to examine whether pump treatment combined with the use of continuous glucose monitoring system is a mena to normalize glycaemic control.
Detailed description
In this study, 100 subjects, users of Paradigm 522/722 Infusion Pump and Self- Monitoring Blood Glucose finger sticks for the control of their glucose levels for at least 3 months prior enrollment will participate. Moreover the subjects won't have achieved the best blood glucose control, with an average HbA1c above 7% and should meet all the inclusion and none of the exclusion criteria. The HbA1c value for screening purposes can be taken from the medical chart, while in the enrollment visit according to current medical practice of each investigational center, the sample taken for HbA1c measurement will be analyzed centrally by HPLC, in a lab in Germany. In all enrolled patients a continuous glucose monitoring system will be provided. Since this is an observational study, the provision of the glucose monitoring system will be based on medical justification and will not be done per protocol requirement. All subjects will be followed for 3 months according to the current medical practice of each investigational center. All other visits, e.g. patient comes into the hospital because of symptoms, will also be recorded as unscheduled visits. These visits are usually linked to Adverse Events.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- This is an observational pilot study that does not have a statistically powered primary hypothesis. The data collected during this study are for the purpose of accumulating information that may generate research ideas and lead to publications. For this reason a sample size of 100 subjects has been defined. The statistical analysis will be descriptive statistics and will be described in a separate statistical analysis plan. Moreover any enrolled patient that has a sensor usage % in the end of the study that is less than 65% will be excluded from the analysis.
Key inclusion criteria (7 listed)
- Subjects and/or their legal representative must sign the Patient Data Release Form (PDRF).
- Subjects must be aged between 12 and 45 years old.
- Subjects must be pump and Self- Monitoring Blood Glucose fingersticks users for at least 3 months and no more than 9 months.
- HbA1c >7.0% with a measurement no older than three months prior to enrollment.
- Diagnosed T1D at least 1 year before study entry.
Key exclusion criteria (6 listed)
- Hearing or vision impairment so that alarms can not be recognized.
- Alcohol or drug abuse other than nicotine.
- Subjects suffering from severe chronic disease or genetic disorder other than T1D. (i.e. Down syndrome etc.)
- Subjects suffering from allergy.
- Subjects in pregnancy or with desire to conceive during study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The levels of HbA1c will be investigated on patients combining the pump therapy with continuous glucose monitoring over a period of three months.
Time frame: 2 years
8 secondary outcomes
To evaluate the impact of continuous sensing on the variability of glucose
Time frame: 2 years
To examine the frequency of hypoglycemic events.
Time frame: 2 years
To examine the frequency of ketoacidosis events
Time frame: 2 years
To examine the frequency of Emergency Department visits
Time frame: 2 years
To examine the frequency of hospitalizations
Time frame: 2 years
To examine the duration of hospitalizations
Time frame: 2 years
To evaluate the daily insulin requirements
Time frame: 2 years
To evaluate the % sensor usage
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2011.
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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.
Charalampos Vasilopoulos, Dr. principal investigator
General Hospital of Athens "Evaggelismos"
Christos Zoupas, Dr. principal investigator
Diagnostic and Therapeutic Center of Athens "Hygeia"
Marriana Benroubi, Dr. principal investigator
General Hospital of Athens "POLICLINIC"
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Medtronic Hellas Medical Devices ΑEE.
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 6 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: status not confirmed, as of the sponsor's last update on 9 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
The levels of HbA1c will be investigated on patients combining the pump therapy with continuous glucose monitoring over a period of three months. (time frame: 2 years). 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 9 Jun 2011.