Continue Glucose Monitoring Before Insulin Pump

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02813421

Run by

Children's Hospital Los Angeles

People needed

11

Starts

2016-03-01

Expected to finish

2017-05-01

Last updated by the study team

2021-05-25

Who can join

Age: 2 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and Females aged 2-24 years
• Clinical diagnosis of Type 1 diabetes mellitus
• Duration of diabetes: At least 6 months
• This will ensure some glycemic stability prior to study, and most children do not start on an insulin pump until about 6 months into their diagnosis.
• Basal/bolus insulin regimen using long-acting and rapid-acting insulin
• This will provide a uniform method of insulin therapy.
• Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2
• Willingness to wear the iPro®2 for 5 days continuously per insertion
• Participant agrees to comply with the study protocol requirements
• Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights signed by the participant and/or parent guardian

You may not qualify if…

• Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control
• Glucocorticoid use within 2 weeks of study enrollment
• Concurrent use of other medications that may affect glycemic control
• Prior CGM use in the past 6 months
• The participant has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of iPro®2 placement that has not been resolved at the time of enrollment and would inhibit the participant from wearing the iPro®2.
• Non-English or non-Spanish speaking

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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