Diabetes Multicenter Observational Study (DIAMOND-1-)

Diabetes Clinical Trial

— 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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01369823
• Other study ID #: Version 1.0 - 12/Sep/2008
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 7, 2011
• Last updated: June 8, 2011
• Start date: June 2009
• Est. completion date: December 2011

Study information

• Verified date: June 2011
• Source: Medtronic Hellas Medical Devices ?EE
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics CommitteeGreece: National Organization of Medicines
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Hellas Medical Devices ?EE

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the impact of continuous sensing on the variability of glucose		2 years	No
Secondary	To examine the frequency of hypoglycemic events.		2 years	No
Secondary	To examine the frequency of ketoacidosis events		2 years	No
Secondary	To examine the frequency of Emergency Department visits		2 years	No
Secondary	To examine the frequency of hospitalizations		2 years	No
Secondary	To examine the duration of hospitalizations		2 years	No
Secondary	To evaluate the daily insulin requirements		2 years	No
Secondary	To evaluate the % sensor usage		2 years	No