CGM-Assisted Insulin Dosing for Cystic Fibrosis-Related Diabetes
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should already be using basal bolus insulin, so you may need to continue with that.
What data supports the effectiveness of the treatment Continuous Glucose Monitoring System for Cystic Fibrosis-Related Diabetes?
Research shows that using continuous glucose monitoring systems, like the Tandem t:slim X2 pump with Control IQ technology, can improve blood sugar control in people with cystic fibrosis-related diabetes by increasing the time their blood sugar stays within the target range and reducing high blood sugar levels.12345
Is CGM-assisted insulin dosing safe for humans?
Research shows that various types of insulin, including those used with continuous glucose monitoring systems, have been studied for safety in humans. Studies have generally found them to be safe, with no significant differences in safety outcomes between different insulin types when used in systems like the MiniMed 670G.678910
How does the drug insulin differ from other treatments for cystic fibrosis-related diabetes?
Insulin is the recommended treatment for cystic fibrosis-related diabetes because it directly helps manage blood sugar levels, even though it may not always provide optimal control. Unlike oral medications, insulin is injected, which can be more invasive, but it offers flexibility in managing the variable food intake and activity levels common in cystic fibrosis patients.111121314
What is the purpose of this trial?
The aim of this study is to assess the utility of CGMs to determine the optimal method to dose meal-time insulin. The investigators will examine glucose excursions in patients with CF who will dose meal-time rapid-acting insulin by carbohydrate counting versus fixed-dose rapid-acting insulin. The carbohydrate ratio and fixed doses will be determined by existing doses, total daily insulin doses, body weight, and insulin sensitivity along with predisposition to hypoglycemia. Bolus insulin dosing is an important part of CFRD management due to the high nutritional demands of these patients. If dosed incorrectly, this could lead to marked hyperglycemia and could worsen nutritional status due to urinary glucose losses. In this project, the investigators will perform a within-subjects' comparison of the 2 standard methods of meal-time rapid-acting insulin dosing.
Research Team
Jagdeesh Ullal, MD
Principal Investigator
University of Pittsburgh Medical Center
Eligibility Criteria
This trial is for adults over 18 with cystic fibrosis-related diabetes, including those who've had a lung transplant and are on basal bolus insulin therapy. It's not open to current CGM users or those unable to perform fingerstick blood sugar tests.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive meal-time rapid-acting insulin by carbohydrate counting versus fixed-dose rapid-acting insulin
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Continuous glucose monitor (CGM)
- Insulin
Insulin is already approved in European Union, United States, Canada for the following indications:
- Diabetes mellitus
- Diabetes mellitus
- Diabetes mellitus
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jagdeesh Ullal
Lead Sponsor
Wake Forest University Health Sciences
Collaborator