Can a wearable sensor help young people with type 1 diabetes tame blood sugar swings?

NCT ID NCT03263494

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests whether using a continuous glucose monitor (CGM) — a small sensor that tracks blood sugar levels in real time — helps teens and young adults (ages 14 to under 25) with type 1 diabetes improve their blood sugar control compared to standard fingerstick testing. Participants are randomly assigned to use either a CGM or a traditional blood glucose meter for six months, with the main goal being a lower HbA1c level. The study also looks at quality of life and other blood sugar measures.

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 Monitor (CGM) device
What this could lead to
If successful, this could show that CGM helps young people with type 1 diabetes achieve better blood sugar control, potentially reducing long-term complications.
What could go wrong
This is a relatively small trial, and results may not apply to all age groups or those with very poor or very good control. The device requires consistent use and may cause skin irritation or data inaccuracies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

153 people

The number who actually took part.

Started

Jan 2018

Finished

Nov 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

14 to 24 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 T1D, with either age of T1D diagnosis \< 10 years of age OR a history of positive T1D related antibodies in the medical record 2. Age 14-\<25 years 3. Diabetes duration ≥ 1 year 4. Total daily insulin requirement ≥ 0.4 units/kg/day 5. HbA1c 7.5% to \<11.0% (Point of care device or local lab measured as part of study at screening visit) 6. Insulin regimen involves a consistent modality of insulin administration with either use of an insulin pump or at least 3 multiple daily injections of basal and bolus (meal time) analogue insulin. Insulin pump must not have been started within 3 months of consent with no plans to change regimens in the next 6 months 7. Perform at least 2 blood glucose meter checks per day from self-report at screening and an average of at least 2 checks per day from meter download during blinded CGM run in 8. Blinded CGM must be used a minimum of 200 hours (equivalent to 8.3 days) with an average of 1.8 calibrations per day during the blinded CGM screening period. 9. Participant comprehends written and spoken English 10. Participant understands the study protocol and agrees to it (if applicable) Exclusion Criteria: 1. Use of unblinded personal CGM and/or flash CGM, outside of a research study, as part of real-time diabetes management in the last 3 months 2. Unable to use CGM device for minimum number of hours during blinded pre-randomization period or skin reaction from adhesive that would preclude participation in the randomized trial 3. Started on non-insulin medication for blood glucose control within the past 3 months or plans to begin within the next 6 months 4. The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors (such as a skin condition), or the completion of any aspect of the protocol. 5. More than 1 episode of DKA in the past 6 months as defined in the adverse events chapter. 6. The presence of any of the following diseases: * Asthma or any condition present in the last 6 months where treatment is a systemic or daily inhaled corticosteroid (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment) * Cystic fibrosis * Addison's disease (Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment) 7. Inpatient psychiatric treatment in the past 6 months or daily intensive outpatient psychiatric day treatment in the past 3 months. 8. Pregnant (positive test confirmed at screening) or planning to become pregnant in the next 12 months. 9. Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial 10. Participation in a diabetes related intervention study in the past 6 weeks. 11. Any medical, psychological or social situation where per investigator discretion it may be difficult for participant to participate fully in the intervention 12. Any condition, per investigator assessment, that could impact reliability of the A1C measurement, such as (but not limited to) hemoglobinopathy, hemolytic anemia, chronic liver disease; chronic GI blood loss, red blood cell transfusion or erythropoietin administration within 3 months prior to screening

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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

  • Barbara Davis Center--University of Colorado

    Aurora, Colorado, 80045, United States

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Mercy Hospital

    Kansas City, Missouri, 64111, United States

  • IDC at Park Nicollet

    Saint Louis Park, Minnesota, 55416, United States

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

  • Naomi Berrie Diabetes Center at Columbia University

    New York, New York, 10032, United States

  • Rocky Mountain Diabetes & Osteoporosis Center

    Idaho Falls, Idaho, 83404, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27713, United States

  • Vanderbilt University

    Nashville, Tennessee, 37212, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

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