Hybrid closed loop insulin pump system for people with diabetes caused by chronic pancreatitis

ISRCTN	ISRCTN24340577
DOI	https://doi.org/10.1186/ISRCTN24340577
Integrated Research Application System (IRAS)	366731
Central Portfolio Management System (CPMS)	72722
National Institute for Health and Care Research (NIHR)	303033
Sponsor	Newcastle upon Tyne Hospitals NHS Foundation Trust
Funder	National Institute for Health and Care Research

Submission date: 20/04/2026
Registration date: 06/05/2026
Last edited: 03/06/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
People with chronic pancreatitis often develop diabetes as a result of damage to the pancreas (sometimes called type 3c or pancreatogenic diabetes). Managing blood sugar levels in this condition is particularly difficult because people may also experience pain, digestion problems and unpredictable glucose changes. Currently, treatment guidance is largely based on evidence from other types of diabetes, and there is very little research on whether newer diabetes technologies are suitable for this group.
Advanced hybrid closed-loop insulin systems combine an insulin pump with a glucose sensor to automatically adjust background insulin levels. These systems are widely used in type 1 diabetes but have not been studied in people with diabetes caused by chronic pancreatitis.
The aim of this study is to find out whether it is feasible and acceptable to run a larger clinical trial comparing advanced hybrid closed-loop insulin therapy with standard insulin treatment in people with chronic pancreatitis–related diabetes. The study will also explore participants’ experiences of using these technologies and of taking part in the trial.

Who can participate?
Adults aged 18 years or older who:
• Have chronic pancreatitis and diabetes related to their pancreatic disease
• Are treated with insulin (twice-daily injections or multiple daily injections)
• Have above-target blood glucose levels or experience problematic low blood sugars
People cannot take part if, for example, they have type 1 or type 2 diabetes, have had pancreatic cancer or major pancreatic surgery, are currently using an insulin pump, are pregnant, or have other conditions that would make participation unsafe or difficult.

What does the study involve?
A total of 24 participants will take part in this single-centre study at Newcastle Diabetes Centre. After joining the study and completing baseline assessments, participants will be randomly allocated (by chance) to one of two groups:
• Advanced hybrid closed-loop group: participants will use an insulin pump that automatically adjusts insulin delivery using information from a continuous glucose monitor, alongside training and clinical support.
• Standard care group: participants will continue their usual NHS care, which typically involves insulin injections and continuous glucose monitoring.
The study lasts around 16 weeks, including a run-in period and a 12-week study phase. Participants will attend up to 10 study visits, some face-to-face and some remotely (by phone or video). These visits will include support with diabetes management, review of glucose data, questionnaires, and routine blood tests. A smaller number of participants will also be invited to take part in an interview to share their experiences of the study.

What are the possible benefits and risks of participating?
Participants may benefit from:
• Extra support with diabetes management
• Access to advanced diabetes technology (if allocated to that group)
• Helping to inform future research and improve care for others with chronic pancreatitis and diabetes
The risks are similar to those of usual diabetes care and include low or high blood sugar levels, mild discomfort from blood tests or sensor insertions, and possible skin irritation from devices. Some questionnaire or interview questions may feel upsetting, but participants can skip questions or stop at any time. All participants will continue to have access to their usual clinical team throughout the study.

Where is the study run from?
The study is run from Newcastle Diabetes Centre, Freeman Hospital, Newcastle upon Tyne, UK, and is sponsored by Newcastle upon Tyne Hospitals NHS Foundation Trust.

When is the study starting and how long is it expected to run for?
The study is expected to start after regulatory approvals are in place. Each participant will take part for approximately 16 weeks, and the overall study is expected to run over approximately 18–24 months, including recruitment and analysis.

Who is funding the study?
The study is funded by the National Institute for Health and Care Research (NIHR) as part of a Doctoral Fellowship programme.

Who is the main contact?
Dr Ayat Bashir
ayat.bashir@ncl.ac.uk

Contact information

Dr Ayat Bashir
Public, Principal investigator, Scientific

Translational and Clinical Research Institute, Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom

ORCID ID	0000-0002-2814-3877
Email	ayat.bashir@ncl.ac.uk

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Placebo
Assignment	Single
Purpose	Treatment
Scientific title	Advanced hybrid Closed Loop In people with diabetes secondary to chronic Pancreatitis (CLIP): A feasibility randomised controlled trial
Study objectives	The primary objective of this feasibility trial is to examine the feasibility of delivering a full-scale RCT within NHS services, comparing AHCL therapy with standard care (insulin pens and continuous glucose monitoring). Feasibility criteria will be assessed against four a priori criteria defining acceptable levels of (i) Recruitment, (ii) Treatment adherence, (iii) Participant retention and (iv) data completeness. Secondary objectives are to examine the suitability of proposed clinical and health economic measures including patient reported outcome measures. Secondary outcomes from qualitative data will aim to examine the experience of trial processes in addition to the acceptability and usability of AHCL in this population
Ethics approval(s)	Approved 24/04/2026, Nottingham1 REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; 02071048115; Nottingham1.rec@hra.nhs.uk), ref: 23/EM/0034
Health condition(s) or problem(s) studied	Diabetes, chronic pancreatitis
Intervention	If participants are interested to take part, they will be invited to an initial baseline visit to complete baseline assessments and have blood samples taken. These samples will include routine blood samples and additional samples for research. Patients will then attend a randomisation visit in which they will be allocated to either of the study arms. Feedback will be collected at this point about their thoughts with the randomised group and whether they would like to continue in the study. The third visit will be an education visit to support participants with their current devices and any new device. The fourth visit will be a remote review of their blood sugar profile as we would normally do in a telephone clinic appointment. We will also address any queries or problems they have with the study devices. The fifth visit is an in-person (face to face) review. This will be similar to their usual clinic appointments where we will review their study device and insulin regime. We will also take a blood sample to check their sugar control (HbA1c) and additional research blood sample. The sixth visit will be a further telephone review as per the fourth visit. The seventh visit will be similar to the fifth visit however, there will be no blood sampling. Visit 8 and 9 will be telephone reviews similar to the fourth visit. Visit 10 will be the final visit which would be in person to repeat all the blood samples taken at baseline. Participants will be invited to complete questionnaires and if agreeable an interview.
Intervention type	Other
Primary outcome measure(s)	Recruitment rate measured using Percentage of eligible participants who agree to take part at During recruitment period Reasons for declining participation measured using descriptive recording by study team at point of recruitment Completeness of baseline data collection measured using Proportion of required baseline variables collected, with documentation of missing data and reasons at Baseline (up to 4 weeks prior to randomisation) Acceptability of randomisation measured using Participant agreement to randomisation and continuation in allocated arm at randomisation Treatment adherence rate measured using Percentage of participants attending follow-up appointments and engaging with agreed action plans at Throughout 12 week study period Participant retention rate measured using Percentage of participants completing the 12 week study phase at 12 weeks
Key secondary outcome measure(s)	HbA1c, glucose, C peptide, insulin total daily dose measured using Blood sampling and laboratory analysis at Baseline (–4 weeks; HbA1c also at week 0) and 12 weeks Continuous glucose monitoring (CGM) metrics measured using Time in range (3.9–10.0 mmol/L), Time below range (<3.9 mmol/L and <3.0 mmol/L), Time above range (>10.0 mmol/L and >13.9 mmol/L), Coefficient of variation, Standard deviation of mean glucose, Mean sensor glucose at Baseline and 12 weeks Diabetes distress measured using Problem Areas in Diabetes (PAID) questionnaire at Baseline and 12 weeks Hypoglycaemia awareness measured using Gold score and Hypoglycaemia Awareness Questionnaire (Hypo AQ) at Baseline and 12 weeks Fear of hypoglycaemia measured using Hypoglycaemia Fear Survey II at Baseline and 12 weeks Self management practices measured using Diabetes Self Management Questionnaire (DSMQ) at Baseline and 12 weeks Treatment satisfaction measured using Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Baseline and 12 weeks Impact of automated hybrid closed loop system measured using INSPIRE questionnaire at 12 weeks (AHCL arm only) Patient engagement with health measured using Consumer Health Activation Index (CHAI) at Baseline and 12 weeks Anxiety and depression symptoms measured using Hospital Anxiety and Depression Scale (HADS) at Baseline and 12 weeks Sleep quality measured using Pittsburgh Sleep Quality Index (PSQI) at Baseline and 12 weeks Quality of life measured using EQ 5D 5L questionnaire at Baseline and 12 weeks Patient reported global change measured using Patient Global Impression of Change (PGIC) at 12 weeks Healthcare utilisation and treatment costs measured using Recording of GP visits, hospital attendances, dietitian and diabetes nurse contacts, equipment, medication and education costs at Throughout study period; assessed at 12 weeks
Completion date	31/05/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	120 Years
Sex	All
Target sample size at registration	24
Key inclusion criteria	1. A confirmed diagnosis of CP and diabetes 2. Age >=18 years 3. HbA1c >=58mmol/mol or disabling hypoglycaemia (when hypoglycaemia occurs frequently or without warning, so the person is constantly anxious about having hypoglycaemic episodes) at screening as per NICE guidance 4. On insulin (twice daily or MDI) 5. Minimal daily insulin requirement of >=8 units and maximum of 250 units per day
Key exclusion criteria	1. Known diagnosis of T1DM or T2M 2. Age ≤18 years 3. History of pancreatic cancer 4. Pregnant or planning pregnancy or breastfeeding 5. History of partial or total pancreatectomy, excluding Frey’s procedure 6. Currently using an insulin pump 7. Hearing or visual impairment or impairment in dexterity that would hinder ability to manage study devices 8. Untreated coeliac disease, adrenal insufficiency or hyperthyroidism or hypothyroidism 9. Current alcohol excess or illicit drug misuse or prescription drug abuse 10. Diagnosed with an eating disorder 11. Skin conditions located at sites of sensor insertion such as psoriasis or bacterial skin infection 12. Any condition that in the assessment of the investigator would impair the ability of the participant to give informed consent
Date of first enrolment	01/06/2026
Date of final enrolment	31/10/2026

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

Editorial Notes

03/06/2026: Internal review.
20/04/2026: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).