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

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Connecticut Children's Medical Center
Study ID
NCT07459582
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Lactate Meter — OTHER
    Hourly blood lactate levels
  • Accu Chek — DEVICE
    Hourly blood glucose levels

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
10 participants (estimated)

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

Locations (1)

FacilityCityStateZIPSite coordinators
Connecticut Children'sHartfordConnecticut06106
Malaya Mount, MS, RD, CDN
[email protected]
860-837-6700

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By research site
Connecticut Children's· Hartford, CT

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