Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05257460 |
Other study ID # |
136248_Version_7.1 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 25, 2022 |
Est. completion date |
March 25, 2023 |
Study information
Verified date |
May 2023 |
Source |
University of Cambridge |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The main objective of this study is to determine whether home use of day and night closed
loop insulin delivery under free living conditions applying ultra-rapid insulin lispro
(Lyumjev) is superior to home use of closed-loop applying standard insulin lispro (Humalog).
This is a double-blind, single-centre, randomised, crossover design study, involving a run-in
period followed by two study periods during which glucose levels will be controlled either by
an automated closed-loop system using standard rapid acting Humalog or by an automated
closed-loop system using ultra-rapid Lispro in random order.
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 include time spent with glucose levels above and
below target, as recorded by CGM, and other CGM based metrics.
Description:
Purpose of clinical trial The purpose is to determine whether home use of day and night
closed loop applying ultra-rapid insulin lispro is superior to home use of closed loop
applying standard insulin lispro.
Study objectives The study objective is to compare day and night automated closed-loop
glucose control using ultra-rapid insulin lispro with closed loop control using standard
insulin lispro.
EFFICACY: The objective is to assess the efficacy of day and night automated closed-loop
glucose control applying standard insulin lispro in maintaining CGM glucose levels within the
target range from 3.9 to 10.0 mmol/l, as compared to day and night closed-loop using
ultra-rapid acting insulin lispro.
SAFETY: The objective is to evaluate the safety of day and night automated closed-loop
glucose control in terms of episodes of severe hypoglycaemia, hyperglycaemia and other
adverse events and adverse device effects.
UTILITY: The objective is to determine the percentage of time when closed-loop was
operational, and usability and acceptance of the closed-loop system.
Study Design A double-blind, single-centre, randomised, two-period crossover study,
contrasting day and night automated closed-loop glucose control applying standard insulin
lispro with day and night closed-loop control applying ultra-rapid acting insulin lispro.
Study Efficacy Endpoints The primary outcome is the time spent in the target glucose range
from 3.9 to 10.0 mmol/l based on CGM glucose levels during the free living phase.
Secondary outcomes include time spent above and below the target glucose range, based on CGM
levels.
Safety Evaluation Frequency of severe hypoglycaemic episodes as defined by American Diabetes
Association, frequency of severe hyperglycaemia (>20 mmol/L) and / or significant ketosis
(plasma ketones >3mmol/l) and nature and severity of other adverse events.
Utility Evaluation Percentage of time spent in closed-loop. Usability and acceptance of the
closed-loop system will be assessed using a patient experience questionnaire at the end of
the second intervention. Additionally, human factor questionnaires will be administered
following recruitment and at the end of each intervention arm.
Sample Size 24 adults completing the study. Up to 30 subjects will be recruited to allow for
dropouts.
Maximum duration of study for a subject 20 weeks (5 months)
Recruitment The subjects will be recruited through the adult diabetes outpatient clinics or
other established methods at the participating centre.
Consent Participants will be asked to provide written informed consent.
Baseline Assessment Eligible subjects will undergo a baseline evaluation including a blood
sample for the measurement of HbA1c, renal, liver function, full blood count, thyroid
function and coeliac antibody screen (if not done in the previous 3 months). Urine pregnancy
test will be done in females. Human factor questionnaires will be administered.
Study Training and Run-in Period Training sessions on the use of study CGM, insulin pump and
closed-loop system will be provided by the research team. During the 2-4 weeks run-in period,
subjects will use study CGM and insulin pump and will have regular contact with the research
team. At the end of the run-in period, for compliance and to assess the ability of the
subject to use the CGM and study pump safely, before the start of the first home study phase,
at least 7 days of CGM data need to be recorded and safe use of study insulin pump
demonstrated. CGM and insulin pump data during the run-in period will be used to assess
baseline glucose control and optimise treatment before the start of the first home study
phase.
Competency Assessment Competency on the use of study insulin pump, study CGM and closed-loop
system will be evaluated using a competency assessment tool developed by the research team.
Further training may be delivered as required.
Randomisation Eligible subjects will be randomised using randomisation software to the
initial use of closed-loop with ultra-rapid insulin lispro followed by closed-loop with
standard insulin lispro or the alternate order.
Automated closed-loop Training on the use of closed-loop will be provided by the research
team. Automated closed-loop control will be commenced and during the training; the
participant will operate the system under the supervision of the clinical team. Competency on
the use of closed-loop system will be evaluated. Subjects will be advised to use automated
closed-loop system for next 8 weeks
Cross-over Assessment At the end of the first intervention human factor questionnaires will
be administered.
There will be no washout period in phase 4 extension.
End of study assessments A patient experience questionnaire will be given at the end of the
second intervention. Additionally human factor questionnaires will be administered.
Procedures for safety monitoring during trial Standard operating procedures for monitoring
and reporting of all adverse events and adverse device events will be in place, including
serious adverse events (SAE), serious adverse device effects (SADE) and specific adverse
events (AE) such as severe hypoglycaemia.
Criteria for withdrawal of patients on safety grounds
A subject may terminate participation in the study at any time without necessarily giving a
reason and without any personal disadvantage. An investigator can stop the participation of a
subject after consideration of the benefit/risk ratio. Possible reasons are:
Serious adverse events Significant protocol violation or noncompliance Failure to satisfy
competency assessment Decision by the investigator, or the sponsor, that termination is in
the subject's best medical interest Pregnancy, planned pregnancy, or breast feeding Allergic
reaction to insulin Technical grounds (e.g. subject relocates)