Advanced hybrid Closed Loop In people with diabetes secondary to chronic Pancreatitis (CLIP): A feasibility randomised controlled trial
Diabetes, chronic pancreatitis
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.
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
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