N/A
Completed N=14
Clinical Assessment of a Closed-loop Insulin Delivery System
Source: ClinicalTrials.gov NCT01534013 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Percentage Time in Euglycaemia — 71; 66.9 percentage of time
Summary
The purpose of the study is to assess the safety and efficacy of the Imperial College closed loop insulin delivery system (artificial pancreas) in subjects with type 1 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Time in Euglycaemia |
71; 66.9 | — |
| SECONDARY % Time in Hypoglycaemia |
— | — |
| SECONDARY % Time Spent in Hyperglycaemia |
— | — |
| SECONDARY Glycaemic Variability as Measured by MAGE and SD |
— | — |
| SECONDARY Glycaemic Risk as Measured by LBGI and HBG |
— | — |
| SECONDARY Closed Loop Error Grid Analysis |
— | — |
| SECONDARY Glucose Area Under the Curve |
— | — |
| SECONDARY Insulin Requirement in Units/kg/hr |
— | — |
Eligibility Criteria
Inclusion Criteria
- Adults over 18 years of age
- Type 1 diabetes confirmed on the basis of clinical features and a fasting c-peptide <200nmol/L
- Type 1 diabetes for greater than 1 year
- Continuous subcutaneous insulin infusion for greater than 6 months
- HbA1c < 8.5% (69mmol/mol)
Exclusion Criteria
- Recurrent severe hypoglycaemia
- Pregnant or planning pregnancy
- Breastfeeding
- Enrolled in other clinical trials
- Have active malignancy or under investigation for malignancy
Data sourced from ClinicalTrials.gov (NCT01534013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.