Diabetes Multicenter Observational Study (DIAMOND-1-)

NCT01369823 | Unknown

• 1 other identifier: Version 1.0 - 12/Sep/2008
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• The levels of HbA1c will be investigated on patients combining the pump therapy with continuous glucose monitoring over a period of three months.

  2 years

Secondary Outcomes (8)

• To evaluate the impact of continuous sensing on the variability of glucose

  2 years

• To examine the frequency of hypoglycemic events.

  2 years

• To examine the frequency of ketoacidosis events

  2 years

• To examine the frequency of Emergency Department visits

  2 years

• To examine the frequency of hospitalizations

  2 years

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Hellas Medical Devices ΑEE: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 7, 2011
• First Posted: June 9, 2011
• Study Start: June 1, 2009
• Study Completion: December 1, 2011
• Last Updated: June 9, 2011

Record last verified: 2011-06