This clinical trial is investigating the effects of an artificial pancreas (AP) system on brain function in older adults with type 1 diabetes (T1D). The main outcome to be measured will be change in alternate fuel uptake by the brain during hypoglycemia (dangerously low blood glucose).
The details
Glucose is used as fuel by the brain and other parts of the body. When hypoglycemia occurs the brain may use alternate fuels, like lactate. This may lead to changes in the brain, and reduced awareness of hypoglycemia.
A traditional insulin pump continuously delivers insulin. Some insulin pumps also have a continuous glucose monitoring (CGM) system, which monitors glucose levels. APs use information from a CGM system to automatically control the release of insulin from a pump. This trial will examine whether APs may help to reduce hypoglycemia, and hence reduce these changes in the brain.
The main outcome in this trial will be measured as the change in alternate fuel uptake in the brain during hypoglycemia.
Who are they looking for?
This trial is looking for 30 adults who have had T1D for at least 20 years. Their pancreas should not be producing any insulin. HbA1c (measures average blood glucose over the last 3 months) should be less than 8%. They must have had multiple episodes of hypoglycemia in the past, and have been unaware of at least some of these. They must be able to undergo MRI scanning.
Participants may not have significant complications of diabetes, hepatitis or HIV infection, anemia, psychiatric or neurological disease, blood-clotting disease, heart disease, liver disease, or kidney disease. They may not have a high alcohol intake, be vegetarians, or regularly take heavy exercise. Participants must not have a history of drug addiction. They may not have participated in other clinical trials. They may not have donated blood in the last month. Women may not take oral contraceptives, or be pregnant, breast-feeding, or have undergone menopause.
How will it work
The participants will be divided, randomly, into two groups. One group will be treated with an AP system. The other group will continue with their usual insulin pump. The participants will be followed for up to 10 weeks.
After 8-10 weeks, alternate uptake of fuel in the brain during hypoglycemia will be measured. Tests of short-term memory will also be done before and after the study.
