None listed
Conditions
Brief summary
This study aims to evaluate glucose control and safety with a sodium-glucose linked transporter in people living with type 1 diabetes. It will involve the use of continuous glucose monitoring and ketone sensing devices combined with education aimed at minimising the risk of diabetic ketoacidosis. The study will take place over seven months, comprising of two weeks of run-in, three months of intervention with dapagliflozin or placebo, followed by cross-over separated by a two week wash-out. Outcomes regarding glycaemia, ketones, anthropometric, cardio-renal, metabolic and psychological parameters will be assessed. We hypothesize that glucose control will improve without a significant increase in diabetes ketoacidosis occurrences in people with type 1 diabetes on dapagliflozin compared to placebo, with the use of continuous interstitial ketone monitoring in conjunction with education regarding management.
Interventions
After screening, participants will undergo a 2-week run-in period where they will wear a continuous glucose monitor and ketone sensor and receive education about management of sustained hyperglycemia/ketosis.
After run-in, participants will be randomized to either the intervention or placebo.
The intervention will be dapagliflozin 10 mg oral tablet daily for three months.
Adherence to intervention will be monitored by counting number of study drugs returned at the end of intervention.
Wash-out
After screening, participants will undergo a 2-week run-in period where they will wear a continuous glucose monitor and ketone sensor and receive education about management of sustained hyperglycemia/ketosis. After run-in, participants will be randomized to either the intervention or placebo. The intervention will be dapagliflozin 10 mg oral tablet daily for three months. Adherence to intervention will be monitored by counting number of study drugs returned at the end of intervention. Wash-out period is 2 weeks between interventions. Arm 1: dapagliflozin for 12 weeks, then cross-over to Placebo for 12 weeks after washout Arm 2: Placebo for 12 weeks, then cross-over to dapagliflozin for 12 weeks after washout The change in study drug to Dapagliflozin was approved prior to participant enrolment.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age equal to or greater than 18 years; type 1 diabetes of more than 1 year duration; stable on insulin therapy (either on MDI or IPT); HbA1c <10.0%; minimum total daily insulin dose of ??0.4 units/kg/day, access to a mobile phone compatible with the continuous glucose monitoring system; willing to adhere to all requirements of the protocol including wearing and responding to information provided by the continuous ketone sensor for the duration of the study
Exclusion criteria
Pregnancy or planned pregnancy; eGFR<30 ml/minute/1.73m2; a history of diabetic ketoacidosis in the last 3 months; diabetic gastroparesis; tape allergy; unable to exercise; use of low carbohydrate diet; heavy alcohol use; major medical or psychiatric illness that in the opinion of the investigator would interfere with protocol adherence or impact participant safety
Outcome results
None listed