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 32 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 <8.0% and body mass index <97th 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 6 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 containing 30g of carbohydrate) 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
Participants with type 1 diabetes using intensive insulin therapy will be recruited. There will be a lead in period of one week before commencement of the study. This will allow researchers to contact particpants on a daily basis to review blood glucose levels and make any necessary adjustments to insulin doses. This will ensure optimal glycaemic control for the study period. On the day prior to the study a continuous glucose monitor (CGM) will be inserted to measure interstitial glucose levels
Participants with type 1 diabetes using intensive insulin therapy will be recruited. There will be a lead in period of one week before commencement of the study. This will allow researchers to contact particpants on a daily basis to review blood glucose levels and make any necessary adjustments to insulin doses. This will ensure optimal glycaemic control for the study period. On the day prior to the study a continuous glucose monitor (CGM) will be inserted to measure interstitial glucose levels for the duration of the study (6 days). The CGM will be blinded for the duration of the study. Over a period of 6 days, participants will consume a standard evening meal of no more than 60 grams of carbohydrate and low fat, low protein. Participants will give an insulin bolus as per usual management. Approximately 4 hours after each evening meal, participants will consume a test meal as supper, consisting of a protein drink (containing protein in amounts of 0g, 12.5g, 25g, 50g, given in randomised order) mixed with 30g of carbohydrate. There will be 2 evenings of glucose only drinks in amounts of 30g and 50g glucose for comparison. Particpants will have insulin as per usual management for the 30g of carbohydrate. No further food or drink will be given (other than water) overnight unless the participant has an episode of hypoglycaemia (blood glucose < 3.5 mmol/L or becomes symptomatic). Interstitial glucose levels will be measured for the next 8 hours following consumption of the test meal drink. The study will cease after the sixth night and the CGM will be removed. Participants will be contacted daily by phone to assess progress with the study and a food, activity and blood glucose diary will be kept by participants to ensure adherance to the protocol.
Sponsors
John Hunter Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
7 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Type 1 diabetes for at least 12 months HbA1c 8.0% or less BMI < 97th centile Using intensive insulin therapy (multiple daily injection therapy or insulin pump therapy)
Exclusion criteria
HbA1c greater than 8.0% BMI greater than 97th centile Presence of any complications of diabetes Presence of any other major medical conditions
Outcome results
None listed