Home lactate and Accu‑Chek glucose meter accuracy for people with glycogen storage disease
Official title: Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease
Run by Connecticut Children's Medical Center · NCT07459582 · Data updated 2026-11-12
This project will see if a handheld Lactate Plus meter and an Accu‑Chek glucometer give results that match lab blood tests in people with glycogen storage disease types Ia, Ib, and XI.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 60 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Connecticut Children's Medical Center Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Status | Recruiting |
| Started | September 18, 2026 |
| Main results expected | March 2027 |
| Study ends | December 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07459582 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People of any age with confirmed (by genetic testing or liver biopsy) Glycogen Storage Disease Type Ia, Ib, or XI who can consent (or whose guardian can consent) and can attend a single approximately eight-hour admission with hourly blood draws are eligible.
✕Probably not a fit
Patients with unspecified glycogen storage disease, those unable to provide consent, those who decline participation, or those who cannot tolerate hourly blood draws or finger‑sticks would not be eligible or likely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational protocol enrolls patients with genetically or biopsy-confirmed Glycogen Storage Disease Types Ia, Ib, or XI for a one-time, planned admission at Connecticut Children's lasting about eight hours. During the visit participants will have hourly blood draws for laboratory lactate and serum glucose alongside finger‑stick measurements using the Lactate Plus meter and the Accu‑Chek glucometer. The trial compares home device readings directly to the corresponding lab values to quantify accuracy and agreement. No investigational treatments are administered; the procedure is limited to paired blood sampling and point-of-care testing.
Why it matters
Potential benefit: If the devices prove accurate, patients could rely on validated home lactate and glucose readings to monitor metabolism more conveniently and potentially avoid some urgent clinic or hospital visits.
How similar studies have gone: While home glucometers are well validated in diabetes populations, handheld lactate meters and device accuracy specifically in glycogen storage disease patients have been less extensively validated, so this is a relatively targeted and novel comparison.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with diagnosed/confirmed (by liver biopsy or genetic testing) Glycogen Storage Disease Type Ia/Ib (ICD 10 code: E74.01) or XI (74.09). 2. For pediatric participants: Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document 3. For adolescents: assent to participate 4. For adults: Ability to understand and the willingness to sign a written informed consent Exclusion Criteria: 1. Patients with Glycogen storage disease unspecified 2. Patients not meeting inclusion criteria 3. Patients unable to provide consent 4. Patients who decline to be in the study
Where it's running
-
Connecticut Children's
Hartford, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Malaya Mount, MS, RD, CDN — Connecticut Children's
- Study coordinator: Malaya Mount, MS, RD, CDN
- Email: mmount@connecticutchildrens.org
- Phone: 860-837-6700
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.