Diabetes Multicenter Observational Study (DIAMOND-1-)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Diabetes

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| To examine the duration of hospitalizations |  | 2 years | 
| To evaluate the daily insulin requirements |  | 2 years | 
| To evaluate the % sensor usage |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HbA1c, Paradigm 522/722 Infusion Pump, Transmitter (MMT-7703WW), Sensor MMT-7002 (i.e. Glucose Sensor), Levels of HbA1c at enrollment higher than 7