Sensing With Insulin Pump Therapy to Control HbA1c

Completed

Conditions: diabetes
diabetes mellitus
10018424

Registration Number: NL-OMON31759

Lead Sponsor: Medtronic B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

*Type 1 diabetes mellitus diagnosed for at least 12 months prior to signature of informed consent,
*Sub-optimal glycemic control (7.5%*Patient treated by continuous subcutaneous insulin infusion (CSII) for at least 6 months prior signature of informed consent.
*Patient treated within the practice of the investigator*s center at least 6 months prior signature of informed consent.
*Patient has no preliminary experience with the sensor function of the PRT or the Guardian® REAL-Time for the 4 months prior signature of informed consent.

Exclusion Criteria

Existing pregnancy or intention to conceive (as assessed by investigator).
*Hearing or vision impairment so that glucose display and alarms cannot be recognized.
*Three or more incidents in the last 12 months of severe hypoglycaemia with documented BG below 50mg/dL (if possible), resulting in unconsciousness, hospitalisation or third party assistance, where recovery follows treatment with glucose or glucagon or similar.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine whether patients with diabetes mellitus can achieve better<br /><br>glycemic control as evidenced by a drop in HbA1c of 0.3%.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine whether patients with Type 1 diabetes mellitus in sub-optimal<br /><br>glycemic control using PRT compared to CSII alone with SMBG can achieve:<br /><br><br /><br>Reduced glycemic variability<br /><br>Increased time in euglycemia<br /><br>Reduced occurrence of hypo- and hyperglycemia<br /><br>Improved treatment satisfaction<br /><br>Reduced number of severe hypoglycemic events<br /><br>Reduced number of diabetic ketoacidosis events<br /><br>Changed treatment patterns: total daily insulin dose, basal patterns,<br /><br>basal/bolus ratio, number of daily boluses, types of boluses and timing<br /><br>Reduced total number of admissions to emergency room and hospitalizations<br /><br>(number and duration) due to diabetic-related events<br /><br>*Reduced number of days missing school (children/adolescents) or missing work<br /><br>(adolescents/adults), due to diabetic-related events</p><br>