Continuous Glucose Monitoring and Insulin Pump Therapy in Diabetic Gastroparesis (GLUMIT-DG)
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|ClinicalTrials.gov Identifier: NCT01030341|
Recruitment Status : Completed
First Posted : December 11, 2009
Results First Posted : September 3, 2018
Last Update Posted : September 24, 2018
|Study Design||Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment|
Device: CGMS and insulin pump
|Recruitment Details||Forty-five patients (age 18-70 years) with diabetes for >2 years in poor glycemic control (HbA1c >8%) with gastroparesis were recruited from 7 centers of the GpCRC from February 2012 through May 2014. Patients had symptoms for >1 year with Gastroparesis Cardinal Symptom Index (GCSI) scores of ≥18.|
Screening Phase-Baseline glycemic profiles were obtained with blinded sensors to acquire >216 hours of glycemic data over 2 weeks.
Run-In Phase:Participants received detailed instructions in operating the CSII device and had to demonstrate competency in CSII and CGM and electronic CGM data transfer to be enrolled.