CL4P-CF: A trial investigating an automated insulin delivery system for people with CF-related diabetes

Details

CTAP badge
Therapeutic approach
Nutritional-GI
Trial status
Open to recruitment Participating Centres
Trials Tracker ID
TT008081
Last updated
28/03/2023

Full title

Closed-loop for people with cystic fibrosis-related diabetes (CL4P-CF)

Study details

CF-related diabetes (CFRD) is the most common complication of CF. Insulin is used to treat CFRD, either by injections several times a day or using an insulin pump. Insulin can improve body weight and lung function, but current insulin treatment needs regular checking of glucose levels and adjustment of insulin doses. This adds to the burden of CF self-management.

A closed-loop insulin delivery system is made up of three devices which communicate wirelessly via Bluetooth:
• Device 1 is a small glucose sensor which is worn on the arm or abdomen and continuously measures glucose levels.
• Device 2 is an insulin pump that delivers insulin just under the skin.
• Device 3 is a controller on a smartphone App which continuously and automatically adjusts the amount of insulin given by the pump (device 2), depending on the glucose levels measured by device 1.

The CL4P-CF study aims to find out if closed-loop systems can improve glucose control and quality of life compared to standard insulin treatment in young people (≥16 years) and adults with CFRD.

Participants will be randomly allocated to one of two groups, to either use the closed-loop system (closed-loop group) or to carry on with their normal insulin treatment with a glucose sensor (control group). The study will run for 26 weeks. The research team will then compare glucose control between the two groups, by looking at the glucose sensor data collected during the study. We will also compare body weight, lung function and the number of lung infections between the two groups. Participants will be asked about their health and quality of life through questionnaires and interviews.


Phase
Not applicable
Length of participation
7 months
Recruitment target
128
CF sponsor
University of Cambridge
CF sponsor type
Academic

Who can take part?

Age range
16 years and older
Including people

Participant has cystic fibrosis-related diabetes requiring insulin therapy for >3 months
Aged 16 years or older
FEV1 >30% at the screening visit

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CF centres running this trial

In Setup

King's College Hospital (London)

CTAP centre
NHS Trust
King's College Hospital NHS Foundation Trust
Address
King's College Hospital
Denmark Hill
SE5 9RS
Trial Coordinators
Mélanie Le Sayec
In Setup

Manchester (Adults) - Wythenshawe Hospital

CTAP centre
NHS Trust
Manchester University NHS Foundation Trust
Address
Wythenshawe Hospital
South Moor Road
M23 9LT
Trial Coordinators
Sarah Sampson
In Setup

Royal Brompton Hospital (London)

CTAP centre
NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Address
Royal Brompton Hospital
Sydney Street
SW3 6NP
Trial Coordinators
Sophie Pinnell
Recruiting

Cambridge Addenbrooke's Hospital (Paediatrics)

NHS Trust
Cambridge University Hospitals NHS Foundation Trust
Address
Hills Road
CB2 0QQ
Recruiting

Cambridge Royal Papworth Hospital (Adults)

CTAP centre
NHS Trust
Royal Papworth Hospital NHS Foundation Trust
Address
Papworth Road
CB2 0AY
Trial Coordinators
Deepa George
Victoria Christenssen