Status:
COMPLETED
Routine Use of Sensor-Augmented Pump Therapy - a Follow up Study
Lead Sponsor:
Medtronic Diabetes
Conditions:
Diabetes
Eligibility:
All Genders
Up to 69 years
Brief Summary
The aim of this study is to document the routine practice in continuous glucose monitoring (CGM) in patients treated with sensor-augmented pump therapy and to assess clinical outcome (HbA1c) before th...
Detailed Description
The most advanced technologies for the treatment of type 1 diabetes mellitus (T1DM) include insulin pumps for continuous subcutaneous insulin infusion (CSII) and glucose sensors allowing continuous gl...
Eligibility Criteria
Inclusion
- Patient (and/or legal representative) has signed Patient Informed Consent(PIC) AND
- Patient (0-69 years) was diagnosed with Type 1 DM and has been on insulin pump therapy (without any additional insulin injection) for at least 3 months prior to signature of the PIC AND
- HbA1c ≥ 7 %) or
- has experienced at least 2 severe hypoglycemic events in the last 12 months or
- is performing on average more than 10 SMBG per day AND The patient has used, or is using or will start using continuous glucose monitoring as part of the CSII therapy for at least 70% of the time for a minimum of 3 months.
Exclusion
- Participation in any other clinical trial - currently and/or in the last 3 months prior signature of informed consent and/or during the retrospective period of data collection.
- Unwillingness to perform at least 4 BG tests per day
- Unwillingness to maintain contact with HCP
- For children: no reliable contact person
- PREGNANT woman and wish of pregnancy
- Vision and hearing impairment not allowing pump use
- Any disease or drug treatment that can interfere with the outcome of sensor usage.
Key Trial Info
Start Date :
June 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01451372
Start Date
June 1 2011
End Date
December 1 2011
Last Update
February 27 2019
Active Locations (1)
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1
Medtronic AB
Stockholm, Kista, Sweden, 164 21