CGM-Assisted Insulin Dosing for Cystic Fibrosis-Related Diabetes

Recruiting in Palo Alto (17 mi)

Overseen byJagdeesh Ullal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Jagdeesh Ullal

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

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

I am older than 18 years.

I am on a basal-bolus insulin regimen.

I have been diagnosed with diabetes due to cystic fibrosis.

See 1 more

Exclusion Criteria

You can't measure your blood sugar using a fingerstick test.

You are using a continuous glucose monitor.

Treatment Details

Interventions

Continuous glucose monitor (CGM) (Procedure)
Insulin (Insulin)

Trial OverviewThe study compares two ways of dosing meal-time rapid-acting insulin in cystic fibrosis patients: calculating doses based on carbohydrate intake versus using fixed doses. The effectiveness will be measured using continuous glucose monitors.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Fixed Dosing, Followed by Carbohydrate CountingExperimental Treatment2 Interventions

Dosing of premeal insulin with fixed doses

Insulin is already approved in Canada for the following indications: