ClinicalTrials.gg
RecruitingNCT06843330Updated Mar 6, 2026

Accuracy of Lactate Meter in GSDIa

An observational study in Glycogen Storage Disease Type Ia, sponsored by Connecticut Children's Medical Center. Recruiting at 1 site in United States. Open to participants aged 0 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Connecticut Children's Medical Center · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
0 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

The goal of this observational study is to determine if home lactate meters (both capillary and serum sample) are accurate, within 20% of lab serum lactate reading 95% of the time, in a population of patients with glycogen storage disease type 1a and to determine if the Accu Chek Guide glucometer (capillary sample) is accurate, within 20% of lab serum glucose reading 95% of the time, in a population of patients with glycogen storage disease type 1a.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Connecticut Children's Medical Center is the lead sponsor of 59 studies on the registry; 13 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with diagnosed/confirmed (by liver 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 document
  • For adults: Ability to understand and the willingness to sign a written informed consent

Exclusion criteria

Exclusion Criteria:

  • Patients with Glycogen storage disease unspecified 74.00, or Ib
  • Patients not meeting inclusion criteria
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Interventions

  • Deviceblood glucose meter; blood lactate meter

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

06

What researchers measure

Primary outcomes

  1. Home lactate meter accuracy in GSDIa compared with lab lactate

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

    Time frame: Every 1-3 hours for a maximum 33 hours

Secondary outcomes

  1. Glucometer accuracy in GSDIa compared with lab lactate

    Glucose level via finger-stick and lab draw

    Time frame: Every 1-3 hours for a maximum 33 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06843330
Lead sponsor
Connecticut Children's Medical Center
Collaborators
Global Center for Glycogen Storage Disease held at the Jewish Community Foundation
Responsible party
Sponsor
First posted
Feb 24, 2025
Start date
Apr 14, 2025
Primary completion
Mar 10, 2027 (estimated)
Completion
Dec 10, 2027 (estimated)
Last update
Mar 6, 2026

Study contacts

Malaya Mount, MS, RD
Contact
mmount@connecticutchildrens.org
860-837-6700
Rebecca Riba-Wolman, MD
Contact
rriba@connecticutchildrens.org
860-837-6700

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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