Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00760526
First received: September 25, 2008
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Device: Continuous glucose monitor
Device: Home blood glucose monitor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Severe Hypoglycemic Events Experienced by Participants [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
  • CGM Glucose Values (mg/dL) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Percentage of sensors values in range (71 mg/dL to 180 mg/dL)

  • Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    CGM glucose values obtained using a blinded CGM device in the control group and unblinded device in the CGM group after the 26-week visit. Glucose indices were calculated for subjects with at least 24 h of glucose. Seven subjects in the CGM group and one subject in the control group who completed the 26-week visit were missing 26-week CGM data.

  • Measures of Variability: Standard Deviation (SD) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    standard deviation (SD). Each subject has many sensor glucose values. SD was calculated for each subject as a measure of variability and the median over all subjects were reported.

  • Measures of Variability: Mean Absolute Rate of Change [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    mean absolute rate of change

  • Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Mean amplitude of glycemic excursions (MAGE)is a measure of blood glucose variability, an indication of diabetes control. Refer to the 1970 paper by Service for a detailed explanation. Diabetes. 1970 Sep;19(9):644-55

  • Parental Quality of Life Measures: Hypoglycemia Fear Survey [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Hypoglycemia Fear Survey. Scale 0-100 with higher score denoting more fear. The results reported below are the values at 26 weeks.

  • Parental Quality of Life Measures: PAID (Problem Areas in Diabetes) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    The parent completed the PAID survey (psychometric evaluation assessing emotional diabetes related distress)at baseline and at 26 weeks. Scale 0-100 with higher scores denoting worse condition. The results reported below are at 26 weeks.

  • Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    The parent completed the following questionnaires at baseline (prior to initiating use of the blinded CGM device) and at 26 weeks: Blood Glucose Monitoring System Rating Scale. Scale 1-4. Higher score denotes fewer problems in the past month.

  • Parental Quality of Life Measures: CGM Satisfaction Scale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

    Parent completed the CGM satisfaction Scale at 26 weeks. Scoring based on 5-point Likert-type scale with a higher value denoting more favorable response toward CGM use (1-5 where 3 is neutral). CGM Satisfaction Scale has 2 subscales: Benefits of CGM & Lack of Hassles of CGM. For both subscales, higher value denotes more satisfaction (more perceived benefits or fewer hassles) towards CGM use. Favorable denotes agree/strongly agree with a positively worded statement or disagree/strongly disagree with a negatively worded statement. Negative denotes vice-versa. The overall score is the average of all 43 items. The subscale score is mean score of the items grouped in the subscale using factor analysis (see ref below for the details of the factor analysis)

    JDRF CGM Study Group. Validation of measures of satisfaction with and impact of continuous and conventional glucose monitoring. Diabetes Technol Ther 2010;12:679-684



Enrollment: 146
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
continuous glucose monitoring
Device: Continuous glucose monitor
Daily use of a continuous glucose monitor
Other Names:
  • FreeStyle Navigator
  • Medtronic Paradigm System
Active Comparator: 2
Standard glucose monitoring with a home glucose meter
Device: Home blood glucose monitor
Home monitoring 3 or more times a day
Other Name: FreeStyle meter

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   4 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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%
  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 (e.g., injection user switching to a pump, pump user switching to injections, or the addition of Lantus (Glargine) insulin)

Exclusion Criteria:

  1. Diabetes diagnosed <6 months of age
  2. Use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
  3. The presence of any of the following diseases or another disease that the investigator believes to be a contraindication to participation in the protocol:

    • Asthma if treated with systemic or daily inhaled corticosteroids in the last 6 months (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment)
    • Cystic fibrosis (Celiac disease and adequately treated thyroid disease do not exclude subjects from enrollment)
  4. Home use of CGM in past 6 months.
  5. Participation in an intervention study (including psychological studies) in past 6 weeks.
  6. Another member of the same household is participating in this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760526

Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Connecticut
Yale University, School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
United States, Iowa
Children's Hospital of Iowa, Department of Pediatrics
Iowa City, Iowa, United States, 52242
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Investigators
Study Chair: Roy W Beck, MD, PhD Jaeb Center for Health Research
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00760526     History of Changes
Other Study ID Numbers: DirecNet 011, HD041919-01,, HD041915-01,, HD041890,, HD041918-01,, HD041908-01,, HD041906-01,, M01 RR00069,, RR00059,, RR 06022,, RR00070-41
Study First Received: September 25, 2008
Results First Received: October 26, 2012
Last Updated: January 10, 2014
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Continuous Glucose Monitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014