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

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

Sponsors

Lead Sponsor: University of Cambridge

Collaborator: Medical University of Graz

Source University of Cambridge
Brief Summary

The main objective of this study is to determine whether day and night closed-loop insulin delivery for 4 weeks under free living conditions is superior to usual insulin pump therapy in adults with type 1 diabetes and HbA1C<7.5%.

This is an open-label, multi center, randomized, crossover design study, involving a 2-4 week run-in period, followed by two 4 weeks study periods during which glucose levels will be controlled either by an automated day- and night closed-loop system or by subjects usual insulin pump therapy in random order. A total of up to 34 adults (aiming for 24 completed subjects) aged 18 years and older with T1D on insulin pump therapy and HbA1C<7.5% will be recruited through diabetes clinics and other established methods in participating centers.

Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 24/7 telephone support.

The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM during home stay. Secondary outcomes are time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics.

Overall Status Completed
Start Date March 2016
Completion Date October 2016
Primary Completion Date October 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Time spent in the target glucose range (3.9 to 10.0 mmol/l) based on subcutaneous glucose monitoring 4 weeks
Secondary Outcome
Measure Time Frame
Continuous subcutaneous glucose monitoring (CGM) based outcome 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome during overnight period between 24:00 and 06:00 4 weeks
Continuous subcutaneous glucose monitoring (CGM) based outcome during day period between 06:00 to 24:00 4 weeks
Insulin dose 4 weeks
Adverse Events 5 months
Utility Evaluation 4 weeks
Enrollment 29
Condition
Intervention

Intervention Type: Device

Intervention Name: Florence D2A or similar closed loop glucose control system

Description: Subject's glucose level will be controlled by the Florence D2A or similar automated closed loop glucose control system. The system comprises of FreeStyle Navigator 2 ® Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care, Alameda, CA, USA), Dana R Diabecare subcutaneous insulin infusion pump (Sooil Corp. Seoul, South Korea)or similar insulin pump, and MPC-based glucose control algorithm running on a smartphone

Arm Group Label: day and night closed loop control

Intervention Type: Device

Intervention Name: CSII with CGM

Description: Subject glucose level controlled by usual insulin pump therapy in conjunction with continuous glucose monitoring (CGM)

Arm Group Label: usual insulin pump therapy management

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Roman Hovorka Principal Investigator University of Cambridge
Location
Facility:
Medical University of Graz | Graz, A8036, Austria
Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital | Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Location Countries

Austria

United Kingdom

Verification Date

October 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Cambridge

Investigator Full Name: Dr Roman Hovorka

Investigator Title: Dr

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: day and night closed loop control

Type: Experimental

Description: Subjects glucose levels are controlled by Florence D2A or similar closed loop insulin delivery system

Label: usual insulin pump therapy management

Type: Active Comparator

Description: Subject glucose level controlled by usual insulin pump therapy in conjunction with continuous glucose monitoring (FreeStyle Navigator CGM)

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov