None listed
Conditions
Brief summary
Families of children with type 1 diabetes (T1D) have reported high fat and high protein (HF/HP) meals as ‘difficult’ foods, causing prolonged hyperglycaemia after eating. A newly developed Hybrid Closed Loop (HCL) system with an Auto-Mode function uses real-time glucose levels to deliver basal insulin in micro amounts. Yet, there is little evidence on whether Auto-Mode is more effective than standard insulin pump therapy (Manual Mode) at reducing glucose excursions caused by HF/HP foods. This pilot study examines the impact of Auto-Mode on glucose excursions following HF/HP meals compared to Manual Mode. Participants are asked to consume standardised frozen beef lasagne and margherita pizza two nights a week for four weeks, under controlled conditions (4 meals in Manual Mode, 4 meals in Auto-Mode). It is hypothesised that the use of the Auto Mode will reduce glucose excursions after eating HF/HP foods when compared to the participant’s preferred insulin bolus pattern delivery in Manual Mode.
Interventions
This study is a quantitative prospective cross-over design study under free-living conditions.
Participants will be using their personal Medtronic MiniMed 670G insulin pump and their Guardian G3 continuous glucose monitoring (CGM) sensor. Each participant will be re-educated by an accredited practising dietitian on how to bolus for high fat and high protein meals using standard insulin pump therapy (Manual Mode). This will be a 20 minute phone call with each participant. After this, they will
This study is a quantitative prospective cross-over design study under free-living conditions. Participants will be using their personal Medtronic MiniMed 670G insulin pump and their Guardian G3 continuous glucose monitoring (CGM) sensor. Each participant will be re-educated by an accredited practising dietitian on how to bolus for high fat and high protein meals using standard insulin pump therapy (Manual Mode). This will be a 20 minute phone call with each participant. After this, they will have a 2 week run-in period to help optimise their pump settings before commencing the study. Study participants are randomised to begin the study in either Manual Mode or Auto Mode (Hybrid Closed Loop therapy). Participants will be asked to consume 2 standardised frozen beef lasagne meals and 2 standardised frozen margarita pizza meals in each Mode at dinner time (4 dinner study meals in Manual Mode, 4 dinner study meals in Auto Mode). This is a total of 2 nights a week for 4 weeks. There will be no wash out period between the meals as we will not be comparing the effects of a control drug to an intervention drug. Postprandial glucose excursions after eating each study meal in Auto and Manual Mode will be compared. Regular phone calls and text messages will be made to each family after each meal to monitor adherence to the intervention.
Sponsors
Telethon Kids Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
• Type 1 diabetes for more than 1 year • Aged 8 to 18 years • HbA1c less than or equal to 8.5% • On hybrid closed loop therapy for more 1 month and using Auto Mode • Willing and able to consume the test meals containing meat and gluten (pizza and pasta) • Non Halal and non Kosher • Access to internet
Exclusion criteria
• Patients with dietary restrictions (e.g. coeliac disease) – test meals contain gluten • Patients with clinical gastroparesis
Outcome results
None listed