Home lactate and Accu‑Chek glucose meter accuracy for people with glycogen storage disease
Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease
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 |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | N/A to 60 Years |
| Sex | All |
| Sponsor | Connecticut Children's Medical Center Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT07459582 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hartford, Connecticut
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.