Can a wearable sensor help young people with type 1 diabetes tame blood sugar swings?
NCT ID NCT03263494
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 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 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Type 1 diabetes mellitus are added.
By submitting, you agree to our Terms of use
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a common blood pressure pill protect insulin cells in kids with type 1 diabetes?
- Can a 15-Day wearable sensor keep blood sugar on target?
- Can we catch type 1 diabetes before it strikes?
- Can a smart insulin pump outsmart pizza? a trial puts it to the test
- Can a tubeless 'Smart' insulin pump transform diabetes care for kids?
- Can mindfulness tame diabetes distress and blood sugar?