NCT02813421

Continue Glucose Monitoring Before Insulin Pump

Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 2 Years – 24 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to learn more about blood glucose control when people with Type 1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to stable blood glucoses and less frequent insulin pump dose changes during the transition to an insulin pump.

Detailed description

This is a prospective, randomized controlled study. Participants will be asked to wear a Medtronic iPro2 continuous glucose monitor (CGM) 1-2 weeks prior to starting on insulin pump therapy. Depending on randomization groups, participants will either have CGM data used inform starting insulin pump doses (treatment group), or to standard of care for starting on insulin pump (control group). Participants will wear the CGM again during the first 5 days of pump start and at approximately 6 weeks after pump start, in order to collect blood glucose data. Each time the CGM is worn, blood glucoses must be checked 6-8 times daily, and a written log must be completed. Baseline medical information also will be collected at the start of participation. Participants will also be asked to complete a questionnaire at approximately 6 weeks after pump start. Participation in the study will be complete after a standard of care follow up visit approximately 3 months after pump start.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	CGM Informed

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-06-27
• Last updated: 2021-05-25
• Results posted: 2021-05-25

Locations

1 site across 1 country: United States