Clinical trial NCT01369823: Diabetes Multicenter Observational Study (DIAMOND-1-)
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Medtronic Hellas Medical Devices ΑEE
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The levels of HbA1c will be investigated on patients combining the pump therapy with continuous glucose monitoring over a period of three months.
timeFrame: 2 years
Secondary outcomes:
measure: To evaluate the impact of continuous sensing on the variability of glucose
timeFrame: 2 years
measure: To examine the frequency of hypoglycemic events.
timeFrame: 2 years
measure: To examine the frequency of ketoacidosis events
timeFrame: 2 years
measure: To examine the frequency of Emergency Department visits
timeFrame: 2 years
measure: To examine the frequency of hospitalizations
timeFrame: 2 years
measure: To examine the duration of hospitalizations
timeFrame: 2 years
measure: To evaluate the daily insulin requirements
timeFrame: 2 years
measure: To evaluate the % sensor usage
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: General Hospital of Athens "Evaggelismos"
name: Charalampos Vasilopoulos, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Diagnostic and Therapeutic Center of Athens "Hygeia"
name: Christos Zoupas, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Athens "POLICLINIC"
name: Marriana Benroubi, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Children General Hospital " Agia Sofia"
name: Christina Kanaka, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Athens "LAIKO"
name: Nikolaos Tentolouris, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Athens "ALEXANDRA"
name: Maria Alevizaki, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Children Hospital "Aglaia Kiriakou"
name: Andrianni Gerasimidi, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Peiraeus "TZANEIO"
name: Andreas Melidonis, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Heraklion
name: Dimitrios Mamoulakis, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: "Venizeleio - Pananeio" General Hospital of Heraklion
name: Angelos Pappas, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Thessalonica " AXEPA",Α' Propedeutic Pathology Clinic
name: Triantafillos Didaggelos, Lecturer
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Thessalonica " AXEPA" ,Α' Pathology Clinic
name: Ioannis Giovos, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: General University Hospital of Thessalonica "PAPAGEORGIOU",Α' Pathology Clinic
name: Emmanouil Pagkalos, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: General University Hospital of Thessalonica "PAPAGEORGIOU",D' Pediatric Clinic
name: Asimina Galli, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: General University Hospital of Thessalonica "PAPAGEORGIOU",Β' Pathology Clinic
name: Christos Manes, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: General University Hospital of Ioannina
name: Agathoklis Tsatsoulis, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: General University Hospital of Rio- Patra
name: Ioannis Chabeos, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: