Clinical trial Recruiting at 1 site Observational Ages Any age to 60

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.

More Glycogen Storage Disease trials

Quick facts

Study typeObservational
AgesAny age to 60 Years
SexAll
Enrollment10 (estimated)
SponsorConnecticut Children's Medical Center
Academic / other
Locations1 site (Hartford, Connecticut)
StatusRecruiting
StartedSeptember 18, 2026
Main results expectedMarch 2027
Study endsDecember 2027
Registry record updatedOctober 29, 2026
Trial IDNCT07459582 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.