An interventional study of Accu-Chek Spirit Insulin Pump and Accu-Chek Spirit Insulin Pump in Diabetes Mellitus Type 1, sponsored by Hoffmann-La Roche. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-03.
Sponsored by Hoffmann-La Roche · Not applicable, Interventional, and Diagnostic
This is a pilot trial to establish study procedures that allow comparison of various starting basal rate profiles used in Continuous Subcutaneous Insulin Infusion (CSII). Glycemic control achieved by circadian 'slide ruler scale' basal rate versus that achieved by one constant basal rate (flat profile) will be compared during a composite fasting day as well as therapeutic success after 2 weeks of normal activity.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Accu-Chek Spirit Insulin Pump
Device: Accu-Chek Spirit Insulin Pump
One basal rate
Multiple basal rates
Pilot trial to establish endpoints such as "time within target range of a composite fasting day"
Time frame: Study duration
AUC, MAGE, HbA1c, body weight change
Time frame: Study duration
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche