RecruitingPhase 2ACTRN12624000992505

Evaluating Glucose Levels and Risk of Ketoacidosis in People with Type 1 Diabetes Receiving SGLT1/2 inhibitor Therapy Using a Novel Continuous Ketone Sensor; Exercise Sub-Study

Evaluating Glucose Levels and Risk of Ketoacidosis in People with Type 1 Diabetes Receiving SGLT1/2 inhibitor Therapy Using a Novel Continuous Ketone Sensor (PARTNER); Exercise Sub-Study

Sponsor

St Vincent's Hospital Melbourne

Enrollment

24 participants

Start Date

Sep 6, 2024

Study Type

Interventional

Conditions

Type 1 Diabetes

Summary

When people with Diabetes exercise it can make their blood sugar drop too low, for this doctors recommend ways to adjust insulin before exercising. SGLT Inhibitors can increase the risk of Diabetic Ketoacidosis. The Abbott Sensor-Based Ketone Monitoring system will be used to assess the effect ketone responses during exercise in people with type 1 diabetes. We believe that ketones will risk in individuals that undertake high intensity interval exercise.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Exercise can cause blood sugar to drop in people with Type 1 diabetes, particularly during high-intensity exercise. At the same time, a class of diabetes medications called SGLT inhibitors, which help control blood sugar, can increase the risk of a dangerous condition called diabetic ketoacidosis — where the body produces too many acidic ketones. This study uses a new continuous ketone monitoring sensor to track ketone levels during high-intensity interval exercise in people with Type 1 diabetes who are on SGLT inhibitor therapy. The researchers believe that high-intensity exercise will trigger a rise in ketone levels in these patients, and the study aims to establish how significant this rise is and how the sensor performs in monitoring it. Understanding this interaction is important for making exercise safer for people with Type 1 diabetes on these medications. You may be eligible if you are 18 or older, have had Type 1 diabetes for more than one year, have stable insulin therapy, an HbA1c below 10%, and are willing to wear a continuous ketone sensor and follow study protocols including exercise sessions. People who are pregnant, have severely reduced kidney function, had a ketoacidosis episode in the past three months, or cannot exercise are not eligible. The study is run at St Vincent's Hospital Melbourne.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 200 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. 1 exercise session of 40 minutes will be completed after 6-weeks of each arm, a total of two sessions one during the 12-week dapagliflozin and one during the placebo treatment period. The sessions will be conducted between 07:00 and 09:30 in the morning proceeding an overnight fast from the previous evening. The exercise session will be high intensity (80-90% of age predicted max heart rate) interval cardio session on a cycle ergometer. The session will entail 4 x 5min 'hard' intervals ensuring the participant is working between the prescribed heart rate limits. The participant will wear a heart rate monitor to ensure appropriate intensity and these sessions will be supervised by post-doctoral research fellows who have experience conducting clinical research exercise sessions. Wash-out period is 2 weeks between interventions. Arm 1: Dapagliflozin for 12 weeks, exercise session post week 6 of intervention. Then cross-over to Placebo for 12 weeks after washout Arm 2: Placebo for 12 weeks, exercise session post week 6 of intervention. Then cross-over to dapagliflozin for 12 weeks after washout Session attendance will be recorded in our database and monitored by investigators to ensure adherence to exercise session requirements within the required timeframes.