Can a glucose sensor and family coaching tame type 1 diabetes in toddlers?

NCT ID NCT02912728

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

143 people

The number who actually took part.

Started

Jan 2017

Finished

Jun 2019

Lead sponsor

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

2 to 7 years

Sex

Anyone

Healthy volunteers

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

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

  • Indiana

    Indianapolis, Indiana, 46202, United States

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Other studies related to the condition(s) this trial covers.