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INfluenza VaccInation To mitigate typE 1 Diabetes (INVITED trial)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500906-17-01
Acronym
INVITED-2022
Enrollment
100
Registered
2022-09-12
Start date
2023-03-21
Completion date
Unknown
Last updated
2025-08-29

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

Conditions

Type 1 diabetes

Brief summary

Change in fasting residual β cell (C-peptide) function, baseline to 12 months.

Detailed description

Change in fasting C-peptide levels, baseline to 6 months., Change in HbA1c, baseline to 12 months., Change in insulin requirements, baseline to 12 months (measured as total insulin dose per kg body weight per day as a mean for the last 14 days)., Time-In-Range (3.9-10.0 mmol/L) of continuous glucose monitoring over 14 days at 12 months., Percent coefficient of variation of glucose (%CV) over 14 days at 12 months.

Interventions

DRUG0.9% sodium chloride for intra muscular injection from hospital stock

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Change in fasting residual β cell (C-peptide) function, baseline to 12 months.

Secondary

MeasureTime frame
Change in fasting C-peptide levels, baseline to 6 months., Change in HbA1c, baseline to 12 months., Change in insulin requirements, baseline to 12 months (measured as total insulin dose per kg body weight per day as a mean for the last 14 days)., Time-In-Range (3.9-10.0 mmol/L) of continuous glucose monitoring over 14 days at 12 months., Percent coefficient of variation of glucose (%CV) over 14 days at 12 months.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 6, 2026