None listed
Conditions
Brief summary
Gastric emptying (GE) is believed to be a potential mechanism causing individual differences in insulin requirements. However, the role of GE in personalising diabetes management is not well understood, and feasible ways to assess GE in children with T1D in a clinical setting are needed. This project aims to study GE in adolescents with type 1 diabetes (T1D) to examine the relationship between GE and blood glucose levels (BGLs) after eating a mixed meal, and to determine if continuous glucose monitoring (CGM) can be helpful in identifying rates of individuals GE. Thirteen T1D participants using a hybrid close loop system (HCL) will consume a standard meal, and both GE using the breath test technique, and BGLs will be monitored over the subsequent 4 hours. Changes in glucose levels will be monitored by CGM and regular blood sampling throughout the study. CGM traces will be assessed in its potential to use as a marker of GE. The outcomes will provide important information about GE characteristics in young people with T1D and its potential to optimise current strategies of insulin delivery.
Interventions
Participants will be recruited who access the diabetes services in Western Australia, wear continuous glucose monitor (CGM) for > 75% of the time and satisfy the inclusion criteria.
The study will involve a one week run in period to optimise participants insulin settings profiles, Participants will have regular telephone contact with the study doctor to review glucose levels. Where indicated adjustments will be made to insulin settings to optimise basal insulin dose, insulin to carbohydrate ra
Participants will be recruited who access the diabetes services in Western Australia, wear continuous glucose monitor (CGM) for > 75% of the time and satisfy the inclusion criteria. The study will involve a one week run in period to optimise participants insulin settings profiles, Participants will have regular telephone contact with the study doctor to review glucose levels. Where indicated adjustments will be made to insulin settings to optimise basal insulin dose, insulin to carbohydrate ratios and insulin sensitivity factors. This will improve the likelihood of the participants blood glucose level being in the target range between 5-10mmol/L on the study day. For the study visit all participants will arrive early morning after an overnight fast at the outpatient clinic for approximately 5 hours. Participants will consume a standardised solid meal within 10 minutes and gastric emptying will be quantified . Gastric emptying will be measured for up to 4 hours after meal consumption using the validated breath test technique. CGM data will be exported to assess postprandial glycaemic profiles. Blood glucose levels will be measured analogue to the breath test using a glucose oxidase analyser (YSI). Additionally, blood will be collected to measure concentration of gut hormones GLP-1 and GIP. Validated questionnaires will assess meal-related GE symptoms including nausea, bloating and postprandial fullness. The project will be supervised by the principal investigator(s) to ensure it is conducted in compliance with the protocol, GCP and regulatory requirements. Information on participant recruitment and retention, participant safety and data collection will be collated and reviewed on a regular basis. All staff will be trained to ensure appropriate data collection in accordance with ICH-GCP guidelines. They will be trained on how to fill out the CRFs to ensure quality of data
Sponsors
Telethon Kids Institute, Rio Tinto Children's Diabetes Centre-a JDRF Global centre of Excellence
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Type 1 diabetes for at least 1 year Most recent HbA1c <9% within the last 3 months using Hybrid closed system for at least 3 months Using a Dexcom G6 CGM >75% of the time
Exclusion criteria
Presence of a disease affecting the digestion and absorption of nutrients, including coeliac disease and gastroparesis An allergy or intolerance to the study meal Medications intentionally affecting GE (e.g prokinetic agents) or medications that alter GE as a side effect (e.g narcotic analgesics) Not using CGM
Outcome results
None listed