Pancreatic replacement therapy and glycaemic control in diabetes
Research type
Research Study
Full title
Comparison of ambulatory glucose profile prior to and during pancreatic enzyme replacement therapy in patients with diabetes and pancreatic exocrine insufficiency: a single-arm phase IV trial
IRAS ID
214755
Contact name
Katherine Alington
Contact email
Sponsor organisation
Portsmouth Hospitals NHS Trust
Eudract number
2017-001227-45
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
Diabetes is a common chronic condition. About 6% of the UK population already have either type 1 diabetes or type 2 diabetes, and one in ten are at risk of developing diabetes.
People with diabetes may develop problems including diabetic eye disease, numbness in feet, kidney damage and heart problems. We know how to prevent and treat these conditions. However, diabetes can also cause other problems that we know less about, for example, delayed stomach emptying after meals, and problems with the pancreas not producing enough juices to help digest food.
When the pancreas doesn’t produce enough of these digestive juices, patients may have abdominal pain, bloating, diarrhoea and weight loss. This condition is called PEI (pancreatic exocrine insufficiency) and is confirmed by a stool test.
PEI is easily treated by supplementing the digestive juices with a capsule, which contains enzymes for digestion (pancreatic enzyme replacement therapy – PERT). This is taken with every meal and can significantly improve symptoms. This treatment may also improve blood sugar control for people with diabetes, but we are not sure exactly how.
In this study we will monitor sugar levels in patients with diabetes and PEI using a new sensor which sticks to the skin for 2 weeks and measures sugar levels every 15 minutes. We will use this sensor before and after treatment with PERT to give us a better idea of what happens to sugar levels than tests such as HbA1c and fingerprick testing. Patients will continue all their normal medications and diabetes treatments during the study.
Patients will continue to receive PERT from their GP after the study. At the end of the study patients will also be given their sensor results (showing blood sugar levels in more detail), which may help patients to manage their diabetes better in the future.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0224
Date of REC Opinion
7 Jun 2017
REC opinion
Further Information Favourable Opinion