None listed
Conditions
Brief summary
To properly manage type 1 diabetes, individuals are required to measure blood glucose levels (BGL's)regularly and adjust the amount of insulin to be given accordingly. This has been done by matching the amount of insulin with the amount of carbohydrate in a meal. Recent studies have shown that meals high in protein can also significantly increase the BGL. There are recommendations that additional insulin be given with meals containing high levels of protein to prevent post prandial hypergycaemia (elevated BGL's after a meal). However, at this time there is insufficient data to determine how these additional insulin doses should be calculated. A current algorithm used to calculate additional insulin based on protein content in a meal has been shown to cause unacceptable levels of hypoglycaemia. We will recruit 31 people with type 1 diabetes between the ages of 7 and 40 years diagnosed for more than 1 year, using either insulin pump therapy or multiple daily injection therapy. Participants will have a glycated haemaglobin of <8.5% and body mass index <91st centile. Exclusion criteria will be those with co-existing medical conditions. The aim of this study will be to: Define the impact of variable protein loads on post prandial BGL's up to 8 hours. The participants will be contacted daily for the first week to monitor BGL's and adjust insulin doses. A continuous glucose monitoring system (CGMS) which provides continuous measurement of BGL's will be inserted on the first day. For 5 consecutive days participants will be instructed to eat a standardised evening meal containing consistent quantities and type of carbohydrate. The participant will give a standard insulin bolus for the carbohydrate in the meal. They will then be instructed to eat a test meal (protein shake) 4 hours after the evening meal. The participant will fast over night and check the BGL in the morning prior to eating breakfast. If the participant has has a BGL <3.5 mmols/L or has symptoms of hypoglycaemia at any time they will eat 15 grams of carbohydrate as per their usual management. During the test meal study days exercise and evening food will be standardised.
Interventions
The study duration will be 5 days. On day one, the participant will be connected to a continuous blood glucose monitor sensor (CGMS), which will remain in place for the 5 day duration of the study. The CGM sensor is a small plastic catheter inserted just beneath the skin. For 5 consecutive days the participant will be instructed to eat a standard evening meal with consistent amounts and type of carbohydrate. Usual insulin doses will be given prior to the meal for the carbohydrate content. This w
The study duration will be 5 days. On day one, the participant will be connected to a continuous blood glucose monitor sensor (CGMS), which will remain in place for the 5 day duration of the study. The CGM sensor is a small plastic catheter inserted just beneath the skin. For 5 consecutive days the participant will be instructed to eat a standard evening meal with consistent amounts and type of carbohydrate. Usual insulin doses will be given prior to the meal for the carbohydrate content. This will be followed by a test meal (a protein drink) to be consumed 4 hours later. The participant will then fast overnight. The blood glucose level (BGL) will be observed via the CGM every hour for an 8 hour period (overnight). The participant will then test their BGL each morning of the study prior to breakfast with a fingerprick blood test, as per usual diabetes management for individuals with type 1 diabetes mellitus.
Sponsors
Novo Nordisk pharmaceuticals
Eligibility
Sex/Gender
All
Age
7 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Type 1 diabetes mellitus HbA1c <8.5% BMI < 91st centile No other medical conditions Diabetes for > 6 months Using multiple daily injections or insulin pump therapy
Exclusion criteria
HbA1c >8.5% BMI > 91st centile Other co-exisiting medical conditions Complications of diabetes Onset of diabetes <6 months
Outcome results
None listed