Recruiting

Observational Study

Sponsor:

Connecticut Children's Medical Center

Code:

NCT06843330

Conditions

Glycogen Storage Disease Type Ia

Eligibility Criteria

Sex: All

Age: 0 - 60

Healthy Volunteers: Not accepted

Interventions

blood glucose meter; blood lactate meter

Study Details

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

Study ID

NCT06843330

Start date

Apr 14, 2025

Status verified date

Mar, 2026

Completion date

Dec 10, 2027

Anticipated

Primary completion date

Mar 10, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 60

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Interventions

blood glucose meter; blood lactate meter

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

Primary outcome measure

  • Home lactate meter accuracy in GSDIa compared with lab lactate [ Time Frame: Every 1-3 hours for a maximum 33 hours ]

Central Contacts and Locations

Central contacts

Malaya Mount, MS, RD

860-837-6700mmount@connecticutchildrens.org

Rebecca Riba-Wolman, MD

860-837-6700rriba@connecticutchildrens.org

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06107

Contacts

Rebecca Riba-Wolman

860-837-6700rriba@connecticutchildrens.org

More Information

Sponsor

Connecticut Children's Medical Center

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Connecticut Children's Medical Center on 2026-03-06.