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Pancreatic islet cell response to hypoglycaemia in long standing type 1 diabetes

Pancreatic islet cell response to hypoglycaemia in long standing type 1 diabetes - Hypo T1D

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49391
Enrollment
10
Registered
2019-11-19
Start date
2019-09-26
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

diabetes mellitus type 1 Type 1 diabetes

Interventions

The participants will visit our research unit after an overnight fast, where they will receive a fixed insulin infusion and a variable glucose infusion at t=0 to bring the participant in an euglycem
beta cells
Hypoglycemia
Machine learning
Type 1 diabetes

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Type 1 diabetes HbA1c

Exclusion criteria

Exclusion criteria: History of epilepsy Use of medicationknow to induce insulin resistance Use of medication for diabetes other than insulin (analogs) History of cardiovascular disease, kidney disease, liver disease or disease of the central nervous system

Design outcomes

Primary

MeasureTime frame
- Change in serum C-peptide concentration - Time delay between plasma glucose and interstitial glucose measured by a FGM and/or implantable CGM during the emergence and the resolution of a hypoglycaemia - Difference in facial expression as determined by a deep learning module of Microsoft before, during and after hypoglycaemia - Difference in heart rate variability before, during and after hypoglycaemia

Secondary

MeasureTime frame
- Association of differences in facial expression and heart rate variability with counterregulatory mechanisms (norepinephrine, epinephrine, heart rate), hypoglycaemic symptoms (semiquantitive symptom questionnaire and simple cognitive testing) - Change in other products of the islets (for instance glucagon and proinsulin)

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)