Recruiting

Lactate & Glucose

Sponsor:

Connecticut Children's Medical Center

Code:

NCT07459582

Conditions

Glycogen Storage Disease Type IA

Glycogen Storage Disease Type I

Glycogen Storage Disease Type IB

Glycogen Storage Disease Xi

Eligibility Criteria

Sex: All

Age: 0 - 60

Healthy Volunteers: Not accepted

Interventions

Lactate Meter

Accu Chek

Study Details

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

Study ID

NCT07459582

Start date

Aug, 2026

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Interventions

Lactate Meter

Hourly blood lactate levels

Accu Chek

Hourly blood glucose levels

Primary outcome measure

  • 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 [ Time Frame: Hourly x 8 hours ]

Central Contacts and Locations

Central contacts

Malaya Mount, MS, RD, CDN

860-837-6700mmount@connecticutchildrens.org

Malaya Mount

3608889293

Locations

Connecticut Children's

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Malaya Mount, MS, RD, CDN

860-837-6700mmount@connecticutchildrens.org

More Information

Sponsor

Connecticut Children's Medical Center

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • lactate
  • blood glucose

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Connecticut Children's Medical Center on 2026-06-01.