Closing the Loop in Adults With Type 1 Diabetes and HbA1C<7.5% Under Free Living Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2016
• Main ID: NCT02727231
• Date of registration: 29/03/2016
• Prospective Registration: No
• Primary sponsor: University of Cambridge
• Public title: Closing the Loop in Adults With Type 1 Diabetes and HbA1C<7.5% Under Free Living Conditions
• Scientific title: Closing the Loop in Adults With Type 1 Diabetes and HbA1C<7.5% Under Free Living Conditions
• Date of first enrolment: March 2016
• Target sample size: 29
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02727231
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Austria, United Kingdom

Contacts

• Name: Roman Hovorka
• Affiliation: University of Cambridge

Key inclusion & exclusion criteria

Inclusion Criteria:

- The subject has type 1 diabetes as defined by WHO

- The subject is 18 years of age or older

- The subject will have been on an insulin pump for at least 6 months with good
knowledge of insulin self-adjustment including carbohydrate counting

- The subject is treated with one of the rapid acting insulin analogues (Insulin
Aspart, Insulin Lispro or Insulin Glulisine)

- HbA1c <7.5% (58mmol/mmol) based on analysis from central laboratory or equivalent

- The subject is willing to perform regular finger-prick blood glucose monitoring, with
at least 6 measurements per day

- The subject is willing to wear closed-loop system at home and at work place

- The subject is willing to follow study specific instructions

- The subject is willing to upload pump and CGM data at regular intervals

- Female subjects of child bearing age should be on effective contraception and must
have a negative urine-HCG pregnancy test at screening.

Exclusion Criteria:

- Non-type 1 diabetes mellitus

- Any other physical or psychological disease or condition likely to interfere with the
normal conduct of the study and interpretation of the study results

- Current treatment with drugs known to have significant interference with glucose
metabolism, such as systemic corticosteroids, as judged by the investigator

- Known or suspected allergy against insulin

- Subjects with clinically significant nephropathy, neuropathy or proliferative
retinopathy as judged by the investigator

- Significantly reduced hypoglycaemia awareness as judged by the investigator

- More than one episode of severe hypoglycaemia as defined by American Diabetes
Association in preceding 6 months (Severe hypoglycaemia is defined as an event
requiring assistance of another person to actively administer carbohydrates,
glucagon, or take other corrective actions).

- Random C-peptide > 100pmol/l with concomitant plasma glucose >4 mM(72 mg/dl) Total
daily insulin dose > 2 IU/kg/day

- Subject is pregnant or breast feeding or planning pregnancy in near future (within
next 3 months)

- Severe visual impairment

- Severe hearing impairment

- Subjects using implanted internal pacemaker

- Lack of reliable telephone facility for contact

- Subject not proficient in English (UK) or German (Austria)

- Subjects who are living alone

- Additional exclusion criteria specific for Austria: Positive results on urine drug
screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids,
cocaine, opiates).

- Additional exclusion criteria specific for Austria:Positive alcohol breath test.



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

Health Condition(s) or Problem(s) studied

Type 1 Diabetes

Intervention(s)

Device: CSII with CGM

Device: Florence D2A or similar closed loop glucose control system

Primary Outcome(s)

Time spent in the target glucose range (3.9 to 10.0 mmol/l) based on subcutaneous glucose monitoring [Time Frame: 4 weeks]

Secondary Outcome(s)

Continuous subcutaneous glucose monitoring (CGM) based outcome during overnight period between 24:00 and 06:00 [Time Frame: 4 weeks]

Insulin dose [Time Frame: 4 weeks]

Continuous subcutaneous glucose monitoring (CGM) based outcome [Time Frame: 4 weeks]

Adverse Events [Time Frame: 5 months]

Continuous subcutaneous glucose monitoring (CGM) based outcome during day period between 06:00 to 24:00 [Time Frame: 4 weeks]

Utility Evaluation [Time Frame: 4 weeks]

Secondary ID(s)

AP@home04 phase2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Medical University of Graz