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Diabetes Multicenter Observational Study (DIAMOND-1-)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Medtronic Hellas Medical Devices ΑEE
ClinicalTrials.gov Identifier:
NCT01369823
First received: June 7, 2011
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medtronic Hellas Medical Devices ΑEE:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the impact of continuous sensing on the variability of glucose [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To examine the frequency of hypoglycemic events. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To examine the frequency of ketoacidosis events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To examine the frequency of Emergency Department visits [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To examine the frequency of hospitalizations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To examine the duration of hospitalizations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the daily insulin requirements [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To evaluate the % sensor usage [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: December 2011
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

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369823

Sponsors and Collaborators
Medtronic Hellas Medical Devices ΑEE
Investigators
Principal Investigator: Charalampos Vasilopoulos, Dr. General Hospital of Athens "Evaggelismos"
Principal Investigator: Christos Zoupas, Dr. Diagnostic and Therapeutic Center of Athens "Hygeia"
Principal Investigator: Marriana Benroubi, Dr. General Hospital of Athens "POLICLINIC"
Principal Investigator: Christina Kanaka, Dr. Children General Hospital " Agia Sofia"
Principal Investigator: Nikolaos Tentolouris, Dr. General Hospital of Athens "LAIKO"
Principal Investigator: Maria Alevizaki, Assoc. Prof. General Hospital of Athens "ALEXANDRA"
Principal Investigator: Andrianni Gerasimidi, Dr. Children Hospital "Aglaia Kiriakou"
Principal Investigator: Andreas Melidonis, Dr. General Hospital of Peiraeus "TZANEIO"
Principal Investigator: Dimitrios Mamoulakis, Dr. University Hospital of Heraklion
Principal Investigator: Angelos Pappas, Dr. "Venizeleio - Pananeio" General Hospital of Heraklion
Principal Investigator: Triantafillos Didaggelos, Lecturer University Hospital of Thessalonica " AXEPA",Α' Propedeutic Pathology Clinic
Principal Investigator: Ioannis Giovos, Assoc. Prof. University Hospital of Thessalonica " AXEPA" ,Α' Pathology Clinic
Principal Investigator: Emmanouil Pagkalos, Dr. General University Hospital of Thessalonica "PAPAGEORGIOU",Α' Pathology Clinic
Principal Investigator: Asimina Galli, Ass. Prof. General University Hospital of Thessalonica "PAPAGEORGIOU",D' Pediatric Clinic
Principal Investigator: Christos Manes, Dr. General University Hospital of Thessalonica "PAPAGEORGIOU",Β' Pathology Clinic
Principal Investigator: Agathoklis Tsatsoulis, Prof. General University Hospital of Ioannina
Principal Investigator: Ioannis Chabeos, Lecturer General University Hospital of Rio- Patra
  More Information

No publications provided

Responsible Party: Dr. Eleni Papavasileiou / Field Clinical research Specialist, Medtronic Hellas Medical Devices ΑEE
ClinicalTrials.gov Identifier: NCT01369823     History of Changes
Other Study ID Numbers: Version 1.0 - 12/Sep/2008
Study First Received: June 7, 2011
Last Updated: June 8, 2011
Health Authority: Greece: Ethics Committee
Greece: National Organization of Medicines

Keywords provided by Medtronic Hellas Medical Devices ΑEE:
HbA1c
Paradigm 522/722 Infusion Pump
Transmitter (MMT-7703WW)
Sensor MMT-7002 (i.e. Glucose Sensor)
Levels of HbA1c at enrollment higher than 7

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013