None listed
Conditions
Brief summary
To properly manage type 1 diabetes (T1DM), individuals are required to measure blood glucose levels regularly and adjust the amount of insulin to be given accordingly. This is done by matching the insulin doses to the carbohydrate content of a meal. Recent studies have shown that meals high in dietary protein may cause postprandial hyperglycaemia. The paediatric diabetes research team at the John Hunter Children’s hospital published a study demonstrating that meal protein content can significantly affect postprandial blood glucose levels. More recently, our group have published a further study, looking at the impact of pure protein- independent of carbohydrate and fat- on postprandial blood glucose levels in T1DM. We are now in the process of completing a further study that was designed to investigate the effect of consuming protein with carbohydrate only (no fat) on postprandial blood glucose levels and have demonstrated a dose response to increasing amounts of protein when consumed with carbohydrate. These findings have led to recommendations to give additional insulin for meals high in protein to avoid postprandial hyperglycaemic excursions. However, at the present time there is still insufficient data regarding how to safely and effectively calculate and deliver mealtime insulin doses for protein. Therefore, we need to conduct further research in order to determine a safe and effective insulin dosing algorithm for meals high in protein.
Interventions
The aim of this study is to determine a safe and effective insulin dosing schedule to account for the protein content of a meal in order to improve postprandial glycaemia without increasing the risk of hypoglycaemia (low blood glucose levels [BGL's]) in individuals with T1DM.
A continuous glucose monitor (CGM) will be inserted on the day prior to the study to provide continuous
measurement of BGL's. For 5 consecutive days participants will be provided with a test breakfast drink containing 50g
The aim of this study is to determine a safe and effective insulin dosing schedule to account for the protein content of a meal in order to improve postprandial glycaemia without increasing the risk of hypoglycaemia (low blood glucose levels [BGL's]) in individuals with T1DM. A continuous glucose monitor (CGM) will be inserted on the day prior to the study to provide continuous measurement of BGL's. For 5 consecutive days participants will be provided with a test breakfast drink containing 50g protein, 30g protein and non-fat. Insulin doses will be calculated using the participants usual insulin to carbohydrate ratio (ICR) with additional amounts of insulin added in increasing increments of 15% These additional doses will be administered over 5 days in randomised order. The additional insulin amounts will be: a) 0% b) 15% c) 30% d) 45% The insulin bolus will be programmed into the participants own insulin pump to commence delivery 15 minutes prior to consumption of the test meal, as per usual management. The insulin will be delivered using a dual wave or combination type bolus feature of the pump. The insulin will be delivered over 3 hours and the dose will be split 65/35% (65% given up front with the remaining dose given over 3 hours). The participant will be given clear instructions of how to do this (most people using insulin pump therapy would be familiar with using wave bolus options) and the amount of insulin will be calculated by a member of the research team. Participants will be contacted daily by a member of the research team to ensure adherence to the protocol. The participants insulin pump can be uploaded to a secure database each day for research staff to check the insulin doses and delivery.
Sponsors
Hunter Medical Research Institute
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
8 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
Ages 8-40 years Type 1 Diabetes for <1 year, HbA1c<8.1% (64 mmol/mol) BMI <91st centile No other major medical conditions or complications Using insulin pump therapy
Exclusion criteria
Presence of diabetes complications Other major medical conditions HbA1c >8.0% (64 mmol/mol) Unwillingness/inability to follow to follow protocol BMI >91st centile
Outcome results
None listed