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Assessment of Residual Beta-Cell Function in Recently Diagnosed Type 1 Diabetes Patients Using Dried Blood Spot C-Peptide Measurement

Assessment of Residual Beta-Cell Function in Recently Diagnosed Type 1 Diabetes Patients Using Dried Blood Spot C-Peptide Measurement

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037806
Enrollment
250
Registered
2025-08-28
Start date
2025-09-01
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10

Interventions

Group 1: After receiving the study documents, participants provide a small blood sample on a card once, complete a questionnaire, and return both in the prepaid envelope.

Sponsors

DiogenX
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Signed and dated informed consent Using insulin to manage T1D. Short period of insulin independence in conjunction with honeymoon period is permissible, based on PI discretion. Willingness and ability to perform at-home DBS sampling after a regular meal and note glucose level at the time of DBS sampling

Exclusion criteria

Exclusion criteria: Any other type of diabetes, apart from T1D. Concomitant participation in an interventional clinical trial

Design outcomes

Primary

MeasureTime frame
Postprandial C-peptide concentration (pmol/L) measured from dried blood spot samples collected at home by participants approximately 90 minutes after start of consumption of a regular, self-chosen meal.

Secondary

MeasureTime frame
Proportion of participants who successfully complete the DBS collection and return a valid sample (i.e. sufficient sample quality and completeness for C-peptide analysis). Associations between C-peptide concentration and clinical/demographic variables, including: age, time since diagnosis, BMI, insulin use, and available measures of glycemic control

Countries

Germany

Contacts

Public ContactTheresa Herbrand

Profil Institut für Stoffwechselforschung GmbH

241-1221-DGX-DBS@profil.com02131 4018 0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026