Accuracy of Lactate Meter in GSDIa

NCT06843330 | Recruiting FDA Device

• 1 other identifier: 23-137
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, compared to lab serum lactate in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, in a population of patients with glycogen storage disease type 1a.

Conditions

Glycogen Storage Disease Type Ia

Keywords

Glycogen Storage Disease type Ia; Blood lactate; Glycogen Storage Disease Ia blood glucose; GSD I; GSDIa; Blood glucose; Accu chek glucometer; Lactate plus

Outcome Measures

Primary Outcomes (1)

• Home lactate meter accuracy in GSDIa compared with lab lactate

  Lactate level via point of care finger-stick and lab draw

  Every 1-3 hours for a maximum 33 hours

Secondary Outcomes (1)

• Glucometer accuracy in GSDIa compared with lab lactate

  Every 1-3 hours for a maximum 33 hours

Interventions

blood glucose meter; blood lactate meter DEVICE

Blood lactate level measured by finger-stick with over the counter meter. Blood glucose level measured by finger-stick.

Eligibility Criteria

• Age: 0 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients of Connecticut Children's birth to age 60 years with diagnosed Glycogen Storage Disease Type Ia, that are seen in clinic between 7/2020 - 7/2024, or that present to emergency room or are admitted to Connecticut Children's for surgery, acute illness or dose titration admission.

You may qualify if:

• Patients with diagnosed/confirmed (by liver biopsy or genetic testing) Glycogen Storage Disease Type Ia (ICD 10 code: E74.01).
• Connecticut Children's Emergency Department visit and/or admission to Connecticut Children's during time study is active
• For pediatric participants: Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document
• For adults: Ability to understand and the willingness to sign a written informed consent

You may not qualify if:

• Patients with Glycogen storage disease unspecified 74.00, or Ib

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• Global Center for Glycogen Storage Disease held at the Jewish Community Foundation: collaborator

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06107, United States

RECRUITING

MeSH Terms

Conditions

Hepatorenal form of glycogen storage disease

Central Study Contacts

Malaya Mount, MS, RD

CONTACT

860-837-6700; mmount@connecticutchildrens.org

Rebecca Riba-Wolman, MD

CONTACT

860-837-6700; rriba@connecticutchildrens.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 24, 2025
• Study Start: April 14, 2025
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): December 10, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)