N/A
Completed N=42
Glycemic Control and the Brain in Children With Type 1 Diabetes
Source: ClinicalTrials.gov NCT03428932 ↗Enrolled (actual)
42
Serious AEs
4.8%
Results posted
May 2023
Primary outcomePrimary: Changes in Gray Matter Volume in the Brain — -4.83; -9.31 centimeters cubed
Summary
The purpose of this study is to determine if improving diabetes control by better controlling blood sugars, will help improve or normalize brain function as compared to routine diabetes care. We will use either the patient's own insulin routine (injections or insulin pumps) or a closed-loop insulin pump (Medtronic 670G). This system uses a continuous glucose monitor (CGM) and an insulin pump to automatically give insulin and may improve control of blood sugars.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Gray Matter Volume in the Brain |
-4.83; -9.31 | — |
| SECONDARY Changes in Brain Activation (Dorsal Anterior Cingulate, Inferior Frontal Gyrus and/or Parietal Cortex) |
78.58; -119.51 | — |
| SECONDARY Changes in WASI-II Perceptual Reasoning Index (PRI) |
2.05; 6.10 | — |
Eligibility Criteria
Inclusion Criteria
- Be at least 14 and not yet 18 years old
- Must have been diagnosed with T1D prior to 5 years old but after 6 months
- For those diagnosed prior to 1 year of age, a positive blood test for an antibody marker will be required
- Have been born term or near term (≥34 weeks) and weighed more than≥ 2 kg (4.4lbs) at birth
- Be in puberty
Exclusion Criteria
- History of intellectual disability, language or learning disability identified before diagnosis of diabetes, or enrollment in a self-contained special education program
- ADD/ADHD and/or on stimulant medication
- Any known genetic or medical problem that could impair brain development
- Abnormalities of the brain/nervous system, visual or hearing problem
- History of seizures not associated with fever before diabetes diagnosis
- Previous inpatient psychiatric treatment
- Unable to have a MRI of the head due to having metal: including metal ear tubes, full set of braces in mouth (retainer is acceptable), other appliances, or vascular clip
Data sourced from ClinicalTrials.gov (NCT03428932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.