Pancreatic replacement therapy and glycaemic control in diabetes

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 19

Inclusion Criteria

1. Male or Female, aged 18 years or above
2. Diagnosed with Type 1 diabetes or Type 2 diabetes at least 1 year ago, and be receiving oral and / or insulin therapy for diabetes
3. Have 1 or more symptoms of PEI:
3.1. Diarrhoea – Bristol Stool Chart (see appendix) type 5, 6 or 7
3.2. Steatorrhoea or greasy, pale or offensive smelling stools
3.3. Weight loss
3.4. Abdominal pain or cramps
3.5. Bloating or increased flatulence
4. Low faecal elastase level <200mcg/g in last 2 years
5. Willing and able to give informed consent for participation in the study and for GP to be informed

Exclusion Criteria

1. Currently receiving, or have ever received, PERT
2. Current prescription of or planning to commence medication (within next 2 months), other than those for diabetes, that may increase or decrease serum glucose levels such as:
2.1. Oral corticosteroids for more than 7 days
2.2. Antipsychotics
2.3. Nutritional supplements such as Fresubin®
2.4. Weight-loss medication such as orlistat
3. Diagnosed with or suspected diagnosis of:
3.1. Pancreatic malignancy
3.2. Acute pancreatitis or chronic pancreatitis
3.3. Type 3c diabetes or other Type 3 secondary diabetes
3.4. Cystic fibrosis
3.5. Previous or awaited gastric bypass (within next 2 months), pancreatic or extensive small bowel surgery
3.6. Other primary pancreatic disorder or uncontrolled liver disorder (exception: non-alcoholic fatty liver disease)
4. Current or recently resolved (within 2 weeks) acute diarrhoeal episode thought likely to be infectious or other gastroenteritis
5. Current of previous chronic alcohol excess
6. Currently pregnant, recently postpartum (within 6 months) or planning pregnancy before end of study date
7. Currently using a modified diet under dietetic supervision, such as FODMAP
8. Currently receiving supported nutrition, including via nasogastric tube, gastrostomy tube or parenteral nutrition
9. Known allergy to Creon® or any of its components
10. Objection to porcine origin of pancreatin
11. Known allergy to Freestyle Libre Pro adhesive pad
12. Already enrolled, or recently (within 6 weeks) taken part in, another study that may affect glycaemic control or that may affect digestion or absorption or another aspect of the GI system or nutrition

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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