Could a tiny sensor spare newborns dozens of needle sticks?
NCT ID NCT04386005
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
Newborns at risk for low blood sugar (hypoglycemia) currently undergo frequent heel-stick blood tests, which can be painful. This study tests whether a continuous glucose monitor (CGM) placed on the thigh can safely and accurately track glucose levels with far fewer needle sticks. The Dexcom G7 sensor, already approved for older children and adults, will be used in about 50 at-risk newborns to see if it is feasible, precise, and acceptable to parents and nurses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dexcom G7 continuous glucose monitor
- What this could lead to
- If successful, this could lead to a less painful way to monitor blood sugar in newborns at risk for hypoglycemia, reducing needle sticks and catching more low-glucose episodes.
- What could go wrong
- This is a small feasibility study, not yet testing clinical outcomes. The device is not FDA-approved for newborns, and its accuracy in this population is unproven. Skin irritation or inaccurate readings remain possible.
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
-
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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50 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Jun 2026
- 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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1 minute to 2 weeks
- 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: * At-risk newborns (\<48 hours old, all sexes) admitted to the Newborn Nursery or the NICU who meet any of the below criteria: 1. Infant of a diabetic mother (IDM, pre-existing or gestational diabetes) 2. Large for gestational age (LGA, \>90th percentile \[sex-specific\]) 3. Small for gestational age (SGA, \<10th percentile \[sex-specific\]) 4. Late preterm (LPT, 34 0/7 to 36 6/7 weeks' gestation) * Any newborn undergoing routine blood glucose screening in the newborn nursery per the Neonatal Hypoglycemia protocol (includes newborns of mothers taking oral hypoglycemic agents, beta-blocker medications, or systemic steroids within 7 days before delivery; and newborns with clinical manifestations of hypoglycemia) Exclusion Criteria: * Birth weight \<2kg * hypoxic-ischemic encephalopathy * a contraindication to oral feeding * abnormal skin that will preclude placement of the CGM (e.g., skin on the thigh that is not intact) * chromosomal abnormalities or severe congenital anomalies identified ante- or postnatally * infants who are not expected to survive or who are in extremis * additional risk of immunocompromise, including: 1. Skin infections, such as staphylococcus or streptococcus skin infections and herpes (skin, eye, and mouth disease) infection 2. Skin diseases that add additional risk, such as epidermolysis bullosa, ichthyosis, peeling skin syndrome, and hemangiomas 3. Systemic sepsis, viral syndromes 4. Immune diseases such as severe combined immunodeficiency, cancer, T-cell or B-cell deficiencies, inborn errors of metabolism, chromosomal abnormalities, glycogen storage diseases, genetic diseases 5. Abdominal wall defects
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Genom att skicka in godkänner du våra Användarvillkor
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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Penn State Health Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
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