Can a glucose sensor and family coaching tame type 1 diabetes in toddlers?
NCT ID NCT02912728
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing whether continuous glucose monitoring, alone or combined with a family behavioral program, helps children under 8 with type 1 diabetes keep their blood sugar in a healthy range. The trial compares these approaches to standard home blood glucose monitoring. About 143 young children will take part, and the main measure is the percentage of time their glucose stays between 70 and 180 mg/dL.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- continuous glucose monitoring combined with a family behavioral intervention
- What this could lead to
- If it works, this could give families a clearer plan for using continuous glucose monitors in very young children, possibly improving daily blood sugar control and reducing the burden of fingerstick checks.
- What could go wrong
- Young children may not tolerate wearing a sensor, and families may struggle to keep up with the behavioral program. The trial is small and short, so any benefits might not last or apply to all children.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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143 people
The number who actually took part.
- Started
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Jan 2017
- Finished
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Jun 2019
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 7 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the investigator 2. Age 2-\<8 years at consent 3. Diabetes duration ≥ 6 months 4. Total daily insulin ≥ 0.3 units per kg per day 5. HbA1c 7.0% to \<10.0% (Point of care device or local lab measured within 30 days of screening visit used to assess eligibility) 6. No use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days 7. Insulin regimen involves either use of a consistent insulin regimen with an insulin pump in the last 3 months or at least 3 multiple daily injections of basal and bolus (meal time) analogue insulin in the last 3 months (e.g. no change from injections to pump or vice versa in the last 3 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). 8. Perform at least 3 blood glucose meter checks per day from self-report at screening and meter download during blinded CGM run in 9. Not currently using and no plans to begin non-insulin medication for blood glucose lowering during the course of the study 10. Parent or guardian comprehend written and spoken English (This requirement is due to the fact that the questionnaires to be used as outcome measures do not have validated versions in other languages, and interventions will be delivered in English only for the RCT to ensure standardization/fidelity checks across sites). 11. Parent understands the study protocol and agrees to it 12. No expectation that participant/parent 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. Exclusion Criteria: 1. Use of unblinded personal CGM, outside of a research study, as part of real-time diabetes management in the last 30 days 2. Unable to use CGM device for minimum number of hours during blinded run-in period or skin reaction from adhesive that would preclude participation in the randomized trial 3. The presence of a significant medical disorder or 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. 4. More than 1 episode of SH or DKA in the past 6 months (not including DKA at time of dx). 5. The presence of any of the following diseases: * 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 (Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment) 6. Inpatient psychiatric treatment in the past 6 months for either child participant or the primary care giver 7. Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial 8. Participation of parent or child in a diabetes related intervention study in past 6 weeks. 9. Any medical, psychological or social situation where per investigator discretion it may be difficult for family or child to participate fully in the intervention 10. Another member of the same household is participating in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Indiana
Indianapolis, Indiana, 46202, United States
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Other studies related to the condition(s) this trial covers.
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