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

NCT07459582 | Recruiting FDA Device

• 1 other identifier: 25-061
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

lactate; blood glucose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Lactate Meter OTHER

Hourly blood lactate levels

Accu Chek DEVICE

Hourly blood glucose levels

Eligibility Criteria

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

Study Population

Patients birth to age 60 years with diagnosed Glycogen Storage Disease Type Ia/Ib or XI.

You may qualify if:

• 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).
• For pediatric participants: Ability of child's parent/legal guardian to understand and the willingness to sign a written informed consent document
• For adolescents: assent to participate
• 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
• Patients unable to provide consent
• Patients who decline to be in the study

Sponsors & Collaborators

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

Study Sites (1)

Connecticut Children's

Hartford, Connecticut, 06106, United States

RECRUITING

MeSH Terms

Conditions

Hepatorenal form of glycogen storage disease; Glycogen Storage Disease Type I; Glycogen Storage Disease IB; Fanconi Syndrome

Condition Hierarchy (Ancestors)

Glycogen Storage Disease; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Tubular Transport, Inborn Errors; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Malaya Mount, MS, RD, CDN

  Connecticut Children's

  PRINCIPAL INVESTIGATOR

• Rebecca Riba-Wolman, MD

  Connecticut Children's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malaya Mount, MS, RD, CDN

CONTACT

860-837-6700; mmount@connecticutchildrens.org

Malaya Mount

CONTACT

3608889293

Study Design

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

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

US (1)