Diabetes Multicenter Observational Study (DIAMOND-1-)

Medtronic Hellas Medical Devices ΑEE100 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Diabetes

Eligibility

Sex: ALLMin age: 12 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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