N/A
Completed N=69
Routine Use of Sensor-Augmented Pump Therapy - a Follow up Study
Source: ClinicalTrials.gov NCT01451372 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Daily Usage of Blood Glucose Test (BG Testing) — 4.35 number of blood glucose test per day
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 the start of the sensor use to the end of the follow-up period. Moreover, data on treatment satisfaction, and fear of hypoglycemia, cost of the therapy, side effects and treatment interruption will be collected.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Usage of Blood Glucose Test (BG Testing) |
4.35 | — |
| SECONDARY Frequency of Sensor Usage Per Month |
4 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01451372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.