CClinicalTrials.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

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

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients with Glycogen storage disease unspecified 74.00, or Ib
  • Patients not meeting inclusion criteria
04

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.

05

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

06

Study locations

1 of 1 sites recruiting
  • Connecticut Children's Medical Center
    Hartford, Connecticut 06107, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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 ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion