Accuracy of Home Lactate Meter and Accu-chek Glucometer in Patients With Glycogen Storage Disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07459582

Enrollment

Registered

2026-03-10

Start date

2026-08-01

Completion date

2027-12-01

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glycogen Storage Disease Type I, Glycogen Storage Disease Type IA, Glycogen Storage Disease Type IB, Glycogen Storage Disease Xi

Keywords

lactate, blood glucose

Brief summary

The goal of this study is to determine if the Lactate Plus meter is accurate compared to lab lactate levels, and to determine if the Accu chek guide glucometer is accurate compared to lab serum glucose levels in patients with Glycogen Storage Disease Types Ia, Ib and XI. To determine this, patient's will have a one-time planned admission to Connecticut Children's for approximately 8 hours and receive hourly blood draws as well as finger-sticks.

Interventions

OTHERLactate Meter

Hourly blood lactate levels

DEVICEAccu Chek

Hourly blood glucose levels

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To determine if the lactate Plus meter (both capillary and serum sample) readings are within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type Ia/Ib/XI	Hourly x 8 hours

Secondary

Measure	Time frame
To determine if the Accu-Chek Guide glucometer (capillary sample) readings are within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type Ia/Ib/XI	Hourly x 8 hours

Countries

United States

Contacts

CONTACTMalaya Mount, MS, RD, CDN

mmount@connecticutchildrens.org860-837-6700

CONTACTMalaya Mount

3608889293

PRINCIPAL_INVESTIGATORMalaya Mount, MS, RD, CDN

Connecticut Children's

PRINCIPAL_INVESTIGATORRebecca Riba-Wolman, MD