None listed
Conditions
Brief summary
This study will be a randomized controlled trial including children aged 2-16 years and adults >16 years of age, with newly diagnosis type 1 diabetes (< 7 days). Participants will be randomized 2:1 to Omnipod®5 automated insulin delivery device OR standard care (multiple daily insulin injections and continuous glucose monitoring [CGM]). Participants will receive the treatment for 12 weeks. Over this time their CGM data will be analysed, along with HbA1c and psychosocial outcomes from questionnaires and cost to the health system and the participant. We think the participants using Omnipod®5 from diagnosis of type 1 diabetes will have better glycaemic and psychosocial outcomes (such as less distress, more confidence and improved sleep) compared to those using standard care.
Interventions
This study will be a randomized controlled trial including children (2-16 years of age) and adults (>16 years of age) with newly diagnosis type 1 diabetes (< 7 days). Participants will be randomized 2 : 1 to Omnipod®5 automated insulin delivery system OR flexible bolus multiple daily insulin injections (MDI) and continuous glucose monitoring (CGM).
The Omnipod 5 is a tubeless automated insulin pump that is worn on the body and changed every 3 days. It automatically varies insulin delivery based
This study will be a randomized controlled trial including children (2-16 years of age) and adults (>16 years of age) with newly diagnosis type 1 diabetes (< 7 days). Participants will be randomized 2 : 1 to Omnipod®5 automated insulin delivery system OR flexible bolus multiple daily insulin injections (MDI) and continuous glucose monitoring (CGM). The Omnipod 5 is a tubeless automated insulin pump that is worn on the body and changed every 3 days. It automatically varies insulin delivery based on sensor (CGM) glucose levels. The total duration of the intervention in both arms will be 12 weeks. Both arms will be wearing CGM and data from this is automatically uploaded to cloud based data management systems which will be reviewed for adherence and data analysis.
Sponsors
Royal North Shore Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Diagnosis of clinical T1D within last 7 days - For participants 16 years of age at least 1 diabetes antibody needs to be positive. - Body weight greater than or equal to 10 kg or estimated TDD of greater than or equal to > 10 units - Ongoing care to be at RNSH or SCH Randwick - Willing to wear study device/s - Willing to dose insulin according to carbohydrate counting
Exclusion criteria
- Serious skin diseases precluding use of CGM and insulin pump - Unable to count carbohydrates - Unable to use required technology - Requires diluted insulin due to low total daily insulin dose - Paediatric participants to be excluded from the study after randomisation if all diabetes autoantibodies are negative, as a diagnosis of Type 1 diabetes cannot be confirmed. - Participants or carers of participants <16 years of age from non-English speaking background. This has been included due to the intensive education process that is required as part of this study.
Outcome results
None listed