Diabetes Mellitus, Type 1Phase 3NCT00760526
Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM
A Phase 3 study testing Continuous glucose monitor and Home blood glucose monitor in people with Diabetes Mellitus, Type 1, run by Jaeb Center for Health Research at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Continuous glucose monitor and Home blood glucose monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2010to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least twelve months
- Age >4.0 to <10.0 years
- HbA1c >= 7.0%
- 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)
Who cannot join
- Diabetes diagnosed <6 months of age
- 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.
- 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)
- Home use of CGM in past 6 months.
- Participation in an intervention study (including psychological studies) in past 6 weeks.
- Another member of the same household is participating in this study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Children's Hospital of Iowa, Department of Pediatrics
Iowa City, Iowa, 52242
Nemours Children's Clinic
Jacksonville, Florida, 32207
Yale University, School of Medicine
New Haven, Connecticut, 06520
Washington University School of Medicine
St Louis, Missouri, 63110
Stanford University Medical Center
Stanford, California, 94305
About this study
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)
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.
Read the 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
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Continuous glucose monitor, Home blood glucose monitor
- Keywords
- Continuous Glucose Monitor
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitorDevice
Also called FreeStyle Navigator, Medtronic Paradigm System
Daily use of a continuous glucose monitor
Home blood glucose monitorDevice
Also called FreeStyle meter
Home monitoring 3 or more times a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | continuous glucose monitoring Receives: Device: Continuous glucose monitor |
| 2 | Active comparator | Standard glucose monitoring with a home glucose meter Receives: Device: Home blood glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events
Measured: 26 weeks
Secondary outcomes (10)
Number of Severe Hypoglycemic Events Experienced by Participants
Measured: 26 weeks
CGM Glucose Values (mg/dL)
Percentage of sensors values in range (71 mg/dL to 180 mg/dL)
Measured: 26 weeks
Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)
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.
Measured: 26 weeks
Measures of Variability: Standard Deviation (SD)
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.
Measured: 26 weeks
Measures of Variability: Mean Absolute Rate of Change
mean absolute rate of change
Measured: 26 weeks
Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)
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
Measured: 26 weeks
Parental Quality of Life Measures: Hypoglycemia Fear Survey
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.
Measured: 26 weeks
Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)
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.
Measured: 26 weeks
Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale
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.
Measured: 26 weeks
Parental Quality of Life Measures: CGM Satisfaction Scale
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
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roy W Beck, MD, PhD, Study chair, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760526
- Sponsor's protocol ID
- DirecNet 011
- Other IDs
- HD041919-01,, HD041915-01,, HD041890,, HD041918-01,, HD041908-01,, HD041906-01,, M01RR000069, RR00059,
- Status last verified
- Sep 2016
- First submitted
- 25 Sep 2008
- Last updated
- 19 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Mauras N, Beck R, Xing D, Ruedy K, Buckingham B, Tansey M, White NH, Weinzimer SA, Tamborlane W, Kollman C; Diabetes Research in Children Network (DirecNet) Study Group. 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 aged 4 to <10 years. Diabetes Care. 2012 Feb;35(2):204-10. doi: 10.2337/dc11-1746. Epub 2011 Dec 30.
PubMed 22210571Triolo TM, Maahs DM, Pyle L, Slover R, Buckingham B, Cheng P, DiMeglio LA, Bremer AA, Weinzimer SA, Chase HP; Diabetes Research in Children Network (DirecNet) and Type 1 Diabetes TrialNet Study Groups. Effects of Frequency of Sensor-Augmented Pump Use on HbA1c and C-Peptide Levels in the First Year of Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):e61-2. doi: 10.2337/dc15-2201. Epub 2016 Feb 19. No abstract available.
PubMed 26895885Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group. Effectiveness of early intensive therapy on beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-5. doi: 10.2337/dc13-1074. Epub 2013 Oct 15.
PubMed 24130350
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00760526
- Acronym / sponsor ID
- DirecNet 011
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Continuous Glucose Monitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Sep 2008 (estimated)
- Results
- Posted 4 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Continuous glucose monitorcontinuous glucose monitoring |
| 2 | Active comparator | Device: Home blood glucose monitorStandard glucose monitoring with a home glucose meter |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least twelve months
- Age >4.0 to <10.0 years
- HbA1c >= 7.0%
- 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)
Key exclusion criteria (8 listed)
- Diabetes diagnosed <6 months of age
- 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.
- The presence of any of the following diseases or another disease that the investigator believes to be a contraindication to participation in the protocol:
- Home use of CGM in past 6 months.
- Participation in an intervention study (including psychological studies) in past 6 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous glucose monitorAlso: FreeStyle Navigator, Medtronic Paradigm SystemDaily use of a continuous glucose monitor | Device | 1 |
| Home blood glucose monitorAlso: FreeStyle meterHome monitoring 3 or more times a day | Device | 2 |
Primary outcome
Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events
Time frame: 26 weeks
10 secondary outcomes
Number of Severe Hypoglycemic Events Experienced by Participants
Time frame: 26 weeks
CGM Glucose Values (mg/dL)
Time frame: 26 weeks
Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)
Time frame: 26 weeks
Measures of Variability: Standard Deviation (SD)
Time frame: 26 weeks
Measures of Variability: Mean Absolute Rate of Change
Time frame: 26 weeks
Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: 26 weeks
Parental Quality of Life Measures: Hypoglycemia Fear Survey
Time frame: 26 weeks
Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)
Time frame: 26 weeks
Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale
Time frame: 26 weeks
Parental Quality of Life Measures: CGM Satisfaction Scale
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22210571Mauras N, Beck R, Xing D, Ruedy K, Buckingham B, Tansey M, White NH, Weinzimer SA, Tamborlane W, Kollman C; Diabetes Research in Children Network (DirecNet) Study Group. 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 aged 4 to <10 years. Diabetes Care. 2012 Feb;35(2):204-10. doi: 10.2337/dc11-1746. Epub 2011 Dec 30.
- Derived from this study: PubMed 26895885Triolo TM, Maahs DM, Pyle L, Slover R, Buckingham B, Cheng P, DiMeglio LA, Bremer AA, Weinzimer SA, Chase HP; Diabetes Research in Children Network (DirecNet) and Type 1 Diabetes TrialNet Study Groups. Effects of Frequency of Sensor-Augmented Pump Use on HbA1c and C-Peptide Levels in the First Year of Type 1 Diabetes. Diabetes Care. 2016 Apr;39(4):e61-2. doi: 10.2337/dc15-2201. Epub 2016 Feb 19. No abstract available.
- Derived from this study: PubMed 24130350Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group. Effectiveness of early intensive therapy on beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-5. doi: 10.2337/dc13-1074. Epub 2013 Oct 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy W Beck, MD, PhD study chair
Jaeb Center for Health Research
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Continuous glucose monitor and Home blood glucose monitor in people with Diabetes Mellitus, Type 1, run by Jaeb Center for Health Research at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00760526, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.