Diabetes Research in Children Network (DirecNet)

Protocol: A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children (4 to <10 Year Olds)
Status: Closed
Start Date: 03/24/2008
End Date: 12/19/2011
Clinical Trial ID: NCT00760526
Public Dataset:  Download

A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children (4 to <10 Year Olds)

Click Here to View Protocol

Click here to view Diabetes Management Instructions

Tight glycemic control in young children with diabetes is limited by hypoglycemia and the associated risk of impaired cognitive development. There are a number of factors that contribute to the risk of hypoglycemia in this age group; including irregular patterns of eating, inability to recognize and report hypoglycemia, inability to self manage a low blood glucose, and unpredictable peaks and valleys in long acting basal insulins. Young children are also very sensitive to small changes in insulin doses and the inability to deliver insulin by very small increments can only be possible via pump therapy. Night time is the most vulnerable period for hypoglycemia in youth with T1DM, since sleep blunts the counter-regulatory responses to hypoglycemia even in non-diabetic children. A large, multicenter study funded by JDRF explored the use of CGM technology further in a cohort of T1DM patients age 8 - ≥25 years for an entire year; however, young children (<8y/o) were not included. Hence, it remains to be seen whether CGM technology can be used safely, whether it is tolerable and useful in very young children with T1DM, and whether it can improve glycemic control without increasing hypoglycemia. The purpose of this study is to determine the efficacy, tolerability, safety, and effect on quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.

 Subjects with T1D who are 4.0 to <10.0 years old will be enrolled into the multi-center protocol which consists of two phases:

  1. A 6-month randomized trial comparing a CGM group with a control group that will use home glucose meter (HGM) monitoring and have the same number of scheduled phone contacts and visits as the CGM group, followed by:
  2. A 6-month period during which the CGM Group continues to use CGM and CGM is initiated in the control group. This 2nd phase of the study will evaluate whether any beneficial effect seen in the first 6 months can be sustained with longer-term use and less intensive contact. As the control group will initiate CGM use with less intensive contact after the first month than was provided at initiation of CGM use in the CGM group in phase 1, this will also allow us to assess if beneficial effects of CGM use can be obtained with more practical personnel intervention.

To take part in the study, subjects will need to have:
 

  1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least twelve months
  2. Age >4.0 to <10.0 years
  3. HbA1c >7.0% (measured with DCA2000 or other local point-of-care device)
  4. Current insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) for the last three months, with no plans to switch the modality of insulin administration during the next 6 months.
  5. Not been diagnosed prior to 6 months of age
  6. Not be taking a medication or have another disease that the investigator feels would prevent him or her from completing any aspect of the study.
  7. Not used a CGM at home in the last 6 months
  8. Not participating in an intervention study in the last 6 weeks
  9. No expectation that subject will be moving out of the area of the clinical center during the next 12 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 subject will return for a second visit about 6 weeks after the enrollment visit. At this visit, quality of life questionnaires will be completed and 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 randomization visit 14 to 28 days after the blinded CGM was initiated.

  • Subjects who have been compliant with use of the CGM and HGM will be randomized to one of two treatment groups: CGM Group or Control Group
  • For the CGM Group, 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.
  • For the Control Group, a HGM and test strips will be provided. The HGM and pump data (if applicable) will be reviewed and changes will be made in diabetes management as needed. The blinded CGM data will be downloaded but will not be reviewed by study personnel until the end of the first 6 months of the study. Parents will be taught to use the protocol-developed instructions for how to make changes to diabetes management based on HGM data.

Both groups will have follow-up visits at 1,4,8,13,19, and 26 weeks (+/- 1 week) plus one contact between each visit (including one phone contact between the second visit and the one week visit) to review their diabetes management.

  • Both groups will download device data on a weekly basis (if the subject has a computer). Subjects with email access will be instructed to email the downloaded data to the clinical center prior to each phone contact.
  • For both groups, at each visit, the HGM and pump (if applicable) will be downloaded and for the CGM group, the CGM will be downloaded.

In the 13th and 26th weeks, the Control Group will use a blinded CGM for one week. The CGM Group will continue to use the blinded CGM. The Control Group will return the blinded CGM to the clinic after a week. The data will be reviewed by personnel who are not involved in the care of the subject to determine if additional blinded sensor data are needed. The blinded data will not be reviewed by the study personnel for management decisions until the end of the first 6 months of the study.

Following the 26-week visit:

  • Subjects in the RT-CGM Group will continue to use the CGM.
  • Subjects in the Control Group will be provided with a CGM and sensors after the week of blinded use and will have visits after 1 week and 4 weeks, with a phone contact during the first and second weeks.
  • Both groups will have visits after 13 weeks and 26 weeks


Back

© 2007 -2018 Jaeb Center for Health Research
All forms and reports on this site require Adobe Acrobat Reader. Click HERE to download a free copy of Adobe.
Although JCHR supports various web browsers, only Internet Explorer version 11 is fully tested and validated to function on this site.
This site utilizes popup windows.