Closed-loop Insulin Delivery in the General Ward

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01774565
• Date of registration: 18/01/2013
• Prospective Registration: Yes
• Primary sponsor: University of Cambridge
• Public title: Closed-loop Insulin Delivery in the General Ward ANGIE02
• Scientific title: A Randomised Study to Assess the Efficacy and Safety of Automated Closed-loop Glucose Control in Insulin Treated Type 2 Diabetes (Phase 1), Inpatient Hyperglycaemia Requiring Subcutaneous Insulin Therapy (Phase 2 and Phase 3) and to Evaluate Use of Closed-loop Applying Faster Insulin Aspart Versus Standard Insulin Aspart (Phase 4)
• Date of first enrolment: August 2016
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01774565
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland, United Kingdom

Contacts

• Name: Roman Hovorka, PhD, MSc, BSc
• Affiliation: University of Cambridge

Key inclusion & exclusion criteria

Inclusion Criteria:

- Aged 18 years or older

- Type 2 Diabetes for at least 1 year as defined by WHO (phase 1 and 4)

- Inpatient hyperglycaemia requiring subcutaneous insulin therapy (phase 2 and 3)

- Treatment with subcutaneous insulin alone or in combination with oral glucose-lowering
medication(s) (phase 4: basal bolus insulin regime for at least 3 months)

- Receiving parenteral and/or enteral nutrition (phase 3)

- HbA1c<11.0% (phase 4)

Exclusion Criteria:

- Autoimmune type 1 diabetes

- Known or suspected allergy against insulin

- Known proliferative retinopathy

- Current or planned pregnancy or breast feeding

- Unstable or end-stage cardiac and renal disease (phase 1 only)

- Planned surgery during study period (phase 1 only)

- Current in-patient in intensive care unit

- Any physical or psychological disease or medication(s) likely to interfere with the
conduct of the study and interpretation of the study results, as judged by the study
clinician

- Likely discharge earlier than 72 hours (phase 1 only)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Device: Fully Automated Closed-Loop Insulin Delivery

Device: Conventional insulin therapy

Primary Outcome(s)

Time spent in target glucose range (5.6-10.0mmol/l) [Time Frame: Phase 1 (Pilot study) = 72-hours, Phase 2 (Follow-up study) = Up to 15 days]

Secondary Outcome(s)

Between 24 hour period variability [Time Frame: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours]

Number of capillary glucose confirmed hypoglycaemic events <3.5mmol/l [Time Frame: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours]

Proportion of time with glucose levels below 3.0 mmol/l as recorded by CGM [Time Frame: Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4= over 10 hours]

Pre-breakfast, pre-lunch, pre-dinner, and evening capillary glucose values [Time Frame: Phase 2-3 (Follow-up study) = Up to 15 days]

Proportion of time with glucose levels below 5.6 mmol/l and above 10.0 mmol/l as recorded by CGM [Time Frame: Phase 1 (Pilot study) = 72-hours, Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4=between 07:00 and 17:00]

Proportion of time with glucose levels below 2.8 mmol/l as recorded by CGM [Time Frame: Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4= over 10 hours]

Area under the curve of sensor glucose levels below 3.0 mmol/l as recorded by CGM [Time Frame: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours]

Proportion of time with glucose levels in significant hyperglycaemic range (>20mmol/l) as recorded by CGM [Time Frame: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours]

Area under the curve of sensor glucose levels below 3.5 mmol/l as recorded by CGM [Time Frame: Phase 1 (Pilot study) = 72-hours, Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours]

Average glucose levels, as recorded by CGM [Time Frame: Phase 1 (Pilot study) = 72-hours, Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4=between 07:00 and 17:00]

Total daily insulin dose [Time Frame: Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours]

Proportion of time with glucose levels below 3.9 mmol/l as recorded by CGM [Time Frame: Phase 1 (Pilot study) = 72-hours, Phase 2 and Phase 3 (Follow-up study)= Up to 15 days, Phase 4=between 07:00 and 17:00]

Standard deviation and coefficient of variation of glucose levels, as recorded by CGM [Time Frame: Phase 1 (Pilot study) = 72-hours, Phase 2-3 (Follow-up study) = Up to 15 days, Phase 4= over 10 hours]

Secondary ID(s)

ANGIE02

A092763

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University Hospital Inselspital, Berne

Cambridge University Hospitals NHS Foundation Trust