Diabetes Research in Children Network (DirecNet)

Protocol: A Pilot Study to Assess the Feasibility of Real-Time Continuous Glucose Monitoring in the Management of Infants and Toddlers with Type 1 Diabetes
Status: Closed
Start Date: 08/01/2008
End Date: 10/12/2010
Clinical Trial ID:  
Public Dataset:  Download

A Pilot Study to Assess the Feasibility of Real-Time Continuous Glucose Monitoring in the Management of Infants and Toddlers with Type 1 Diabetes

Click Here to View Protocol

Click here to view Diabetes Management Instructions

Because of the unique challenges involved in the use of CGM technology in very small children, including unpredictability of meals, extraordinary sensitivity to very small insulin doses, and very limited body surface area where to place the sensors, to name a few, this study will be extended to children less than age 4 yr (i.e., infants and toddlers) as a pilot assessment of the feasibility of the use of these devices in this young age group.

Following a run-in period with a blinded CGM, CGM use will be initiated in each enrolled subject. Subjects will remain in the study for up to six months as long as the CGM is still being used. If CGM use is discontinued prior to six months, with no intention to restart it, then a close-out visit will be performed at which the testing listed for the 26 week visit will be performed.

To take part in the study, subjects will need:

  1. Clinical diagnosis of type 1 diabetes
  2. Age <4.0 years
  3. Current insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 2 shots per day) for at least one month
  4. No expectation that subject will be moving out of the area of the clinical center during the next 6 months, unless the move will be to an area served by another study center

Study Procedures
On the day of enrollment, a hemoglobin A1c level will be obtained, and potential subjects will be evaluated for study eligibility through the elicitation of a medical history and performance of a physical examination by a study investigator. The parent will be asked to complete a series of quality of life questionnaires. At this visit, a CGM sensor will be inserted. The monitor will be blinded so that the glucose values cannot be seen. The parent will be instructed on insertion, calibration, and care of the CGM.
The subject will return for a second visit about 7-14 days after the enrollment visit. At this visit, compliance with use of the CGM and HGM will be assessed in addition to a skin reaction assessment. If the subject is compliant, the CGM, HGM, and pump data (if applicable) will be reviewed and changes will be made to diabetes management as needed. Parents will be taught to use the protocol-developed instructions for changes to diabetes management to be used in real time based on CGM and HGM data. Instructions for downloading the CGM and HGM will be provided to subjects with a home computer. A hemoglobin A1c level will also be obtained during the visit.
Follow-up visits are scheduled at 1,4,8,13,19, and 26 weeks (+/- 1 week) plus one contact between each visit to review their diabetes management. Compliance with use of the CGM and HGM will be assessed at each visit in addition to a skin reaction assessment. A hemoglobin A1c will be obtained at each visit with the exception of the 1 week visit and the parent will be asked to complete a series of quality of life questionnaires during the 26 week visit.



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