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Type 1 DiabetesNCT02727231

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

A study testing CSII with CGM in people with Type 1 Diabetes, run by University of Cambridge at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
CSII with CGM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesin 2 countries
Study dates
Mar 2016to Oct 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Austria1 site

  • Medical University of Graz

    Graz, A8036

Other trials in Austria

United Kingdom1 site

  • Cambridge University Hospitals NHS Foundation Trust, Addenbrookes Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

Other trials in United Kingdom

About this study

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.

Read more

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.

Conditions
Type 1 Diabetes
Being tested
Florence D2A or similar closed loop glucose control system, CSII with CGM
Keywords
closed loop glucose control, hypoglycemia, type 1 diabetes, HbA1C<7.5%
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Florence D2A or similar closed loop glucose control systemDevice

    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

  • CSII with CGMDevice

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

Study groups in NCT02727231
Study groupRoleWhat they receive
day and night closed loop controlExperimentalSubjects glucose levels are controlled by Florence D2A or similar closed loop insulin delivery system
Receives: Device: Florence D2A or similar closed loop glucose control system
usual insulin pump therapy managementActive comparatorSubject glucose level controlled by usual insulin pump therapy in conjunction with continuous glucose monitoring (FreeStyle Navigator CGM)
Receives: Device: CSII with CGM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time spent in the target glucose range (3.9 to 10.0 mmol/l) based on subcutaneous glucose monitoring

    Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM) during the 4 weeks of home stay. Intention to treat basis.

    Measured: 4 weeks

Secondary outcomes (12)

  1. Continuous subcutaneous glucose monitoring (CGM) based outcome

    Time spent above and below the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM) during the 4 weeks of home stay. Intention to treat basis.

    Measured: 4 weeks

  2. Continuous subcutaneous glucose monitoring (CGM) based outcome

    Average,standard deviation and coefficient of variation of glucose levels during 4 weeks of home periods

    Measured: 4 weeks

  3. Continuous subcutaneous glucose monitoring (CGM) based outcome

    The time with glucose levels < 3.5 mmol/l and <2.8 mmol/l during 4 weeks of home periods

    Measured: 4 weeks

  4. Continuous subcutaneous glucose monitoring (CGM) based outcome

    The time with glucose levels in the significant hyperglycaemia,(glucose levels > 16.7 mmol/l during 4 weeks of home periods

    Measured: 4 weeks

  5. Continuous subcutaneous glucose monitoring (CGM) based outcome

    Low Blood Glucose Index

    Measured: 4 weeks

  6. Continuous subcutaneous glucose monitoring (CGM) based outcome

    The "Area Under the Curve" below 3.5 mmol/l during 4 weeks home periods

    Measured: 4 weeks

  7. Continuous subcutaneous glucose monitoring (CGM) based outcome

    Between 24 hour period variability: Coefficient of variation of CGM glucose between 24 hour periods (midnight to midnight)

    Measured: 4 weeks

  8. Continuous subcutaneous glucose monitoring (CGM) based outcome during overnight period between 24:00 and 06:00

    Time spent with CGM glucose concentration in range 3.9-10.0mmol/L

    Measured: 4 weeks

  9. Continuous subcutaneous glucose monitoring (CGM) based outcome during day period between 06:00 to 24:00

    Time spent with CGM glucose concentration in the target range (3.9-10.0mmol/L)

    Measured: 4 weeks

  10. Insulin dose

    Total, basal and bolus insulin dose during 4 weeks of home periods

    Measured: 4 weeks

  11. Adverse Events

    Safety evaluation will comprise the number of episodes of hypoglycaemia, significant ketonemia (> 3.0mmol/l)as well as nature and severity of any other adverse events

    Measured: 5 months

  12. Utility Evaluation

    Utility evaluation is the percentage of closed-loop operation time during use at home, and when CGM was available

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02727231
Sponsor's protocol ID
AP@home04 phase2
Status last verified
Oct 2016
First submitted
29 Mar 2016
Last updated
11 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Bally L, Thabit H, Kojzar H, Mader JK, Qerimi-Hyseni J, Hartnell S, Tauschmann M, Allen JM, Wilinska ME, Pieber TR, Evans ML, Hovorka R. Day-and-night glycaemic control with closed-loop insulin delivery versus conventional insulin pump therapy in free-living adults with well controlled type 1 diabetes: an open-label, randomised, crossover study. Lancet Diabetes Endocrinol. 2017 Apr;5(4):261-270. doi: 10.1016/S2213-8587(17)30001-3. Epub 2017 Jan 14.

    PubMed 28094136

Questions about this trial

What is this clinical trial studying?

A study testing CSII with CGM in people with Type 1 Diabetes, run by University of Cambridge at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time spent in the target glucose range (3.9 to 10.0 mmol/l) based on subcutaneous glucose monitoring (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02727231, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.

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