This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Sponsor Medtronic
Start date February 2009
End date March 2012
Trial size 300 participants
Trial identifier NCT00790088, EUR04


The aim of the project is to document the international routine practice in sensor usage in patients treated with sensor-augmented pump therapy and to assess which variables (e.g. training of patients, frequency of sensor usage etc) are associated with an improvement in clinical outcome(s) from the start of the sensor use to the end of the follow-up period.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Frequency (as percentage) of sensor usage, estimated as days per month
time frame: every 3 months
time frame: every 3 months
Percentage of patients achieving HbA1c < 7% and < 7.5% depending on different possible influencing factors (sensor usage frequency, training of patients, etc)
time frame: every 3 months

Secondary Outcomes

Glycemic variability
time frame: 3 months
Time spent per day in euglycemia
time frame: every 3 months
Occurrence of hypoglycemia
time frame: every 3 months
Postprandial glucose values measured by AUC
time frame: every 3 months
Treatment satisfaction
time frame: at baseline, after 3 and after 12 months
Fear of hypoglycemia
time frame: at baseline, after 6 and after 12 months
Severe hypo- or DKA-events
time frame: every 3 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patient (and/or legal representative) has signed Patient Informed Consent (PIC) - Patient was diagnosed with Type 1 DM and has been on insulin infusion pump therapy (without any additional insulin injection) for at least 6 months prior to signature of the PIC - The treating physician decided independently of the study to prescribe non-blinded continuous glucose monitoring as part of the patient's pump therapy for at least 10% of the study time (estimated as days per month) Exclusion Criteria: - Participation in any other clinical trial - currently and/or in the last 3 months prior to signature of informed consent - Patient has preliminary experience with non-blinded continuous glucose monitoring prior to signature of informed consent (not naïve to non-blinded continuous glucose monitoring) - For children: no reliable contact person

Additional Information

Official title International Report on Routine Practice of Sensor-enabled Pump Therapy
Principal investigator Ohad Cohen, Prof
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Medtronic.