Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01789593 | A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes | PHASE1 | COMPLETED | 29 | — | — | Jan 14, 2013 | Dec 1, 2013 | Jan 12, 2018 | 1 | Denmark |
| NCT01780272 | A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 Diabetes | PHASE1 | COMPLETED | 26 | — | — | Jan 1, 2013 | Sep 1, 2013 | Jan 23, 2017 | 1 | Denmark |
| Arm | Type | Description |
|---|---|---|
| Hypoglycaemia / euglycaemia clamp | OTHER | - |
| Euglycaemia clamp / hypoglycaemia | OTHER | - |
| Normoglycaemia followed by hypoglycaemia | OTHER | - |
| Hypoglycaemia followed by normoglycaemia | OTHER | - |
| Name | Type | Description |
|---|---|---|
| glucose clamp | OTHER | Each subject will be randomly allocated to an experimental visit sequence consisting of a hypoglycaemic glucose clamp followed by euglycaemic glucose clamp (using i.v. infusion of human soluble insulin (Actrapid®)) or vice versa separated by at least 21 days. Each visit includes an overnight stay. For each of the two conditions (euglycaemia and hypoglycaemia) cognitive performance will be assessed by a validated cognitive test |
Inclusion Criteria: * Right-handed subjects * Type 1 diabetes mellitus for at least 12 months * Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months * Body mass index 18.0-28.0 kg/m\^2 (both inclusive) Exclusion Criteria: * Subje...