Fat and Protein Study
Research type
Research Study
Full title
Investigation of appropriate timing of additional insulin dosing for fat and protein in children with type 1 diabetes using multiple daily injections
IRAS ID
162755
Contact name
Rachel Besser
Contact email
Sponsor organisation
Oxford University Hospitals NHS Trust
Eudract number
2015-003666-85
Research summary
Research Summary
Children with Type 1 diabetes need good control of their blood glucose (BG) levels to prevent long-term complications. To keep BG levels as normal as possible, children are taught to match insulin dose to the amount of carbohydrate in their food. However, recent studies have shown that children using insulin pumps who used insulin doses based on fat and protein as well as carbohydrate were likely to achieve better BG control.
Because the majority of children in the UK use multiple insulin injections rather than pumps, there is now a need to replicate these studies in children using injections. We therefore plan to study how best to increase the
insulin dose for children on multiple daily injections (MDI) eating high-protein and high-fat meals to improve BG levels up to 12 hours after eating.On 3 evenings children will eat a standard high-fat high-protein meal with no further snack during the evening. They will have all the insulin before the meal calculated for the carbohydrate alone. They will then have the additional insulin calculated for the fat and protein given in random order, before, one hour or two hours after the meal.
Using a small sensor just under the skin, we will monitor blood glucose levels after the meal for 12 hours, The glucose sensor recordings will then be downloaded and analysed to see which dosing schedule achieves the best BG control overnight . We will also ask the children and their parents whether the additional insulin injections are acceptable.
Summary of Results
This study was done in children with type 1 diabetes using multiple daily insulin injections to manage their blood glucose levels. It looked at the best way to give additional rapid-acting insulin for meals with high fat and protein content. These meals are often reported to cause rises in blood glucose levels after they have been eaten, despite the usual insulin dose (based on their carbohydrate content) being given beforehand.
Extra insulin for the fat and protein content of these meals was given in three different ways. It was given either as one single dose immediately before eating, or as a split dose over two injections. One of the two injections was given before eating, and the second was given either an hour or two later.
Our study showed that there was no significant difference whether the extra insulin was given all before or as the split doses, however there was reported mild hypoglyceamia (low blood glucose) after the extra insulin. This did not happen in every participant and suggests that there in an individual need for extra insulin for high fat protein meals, but more research is needed to work out exactly how much and when best to give it as injected rapid-acting insulin.REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0658
Date of REC Opinion
16 Nov 2015
REC opinion
Favourable Opinion