Extended Bolus for Meals in a Closed-loop System

Type 1 Diabetes Clinical Trial

Official title:

Postprandial Glucose Control Using an Extended Bolus for High-fat High Protein Meals in a Closed-loop System in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454891
• Other study ID #: 58992
• Secondary ID: 5K23DK121942-02
• Status: Recruiting
• Phase: Phase 4
• Start date: July 15, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: Laya Ekhlaspour, MD
• Phone: 415-514-8531
• Email: laya.ekhlaspour[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system. The new knowledge gained from this study may provide a method to allow for the proper administration of insulin over an extended period to mitigate the risk of prolonged hyperglycemia or early hypoglycemia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria

• Age between 13 and 19 years old, A1C > 6% at screening

• Diagnosed with type 1 diabetes for at least one year

• Total daily dose (TDD) of insulin = 0.3 units/kg/day

• Currently using the Control IQ closed-loop system

• Willing to abide by meal recommendations and study procedures

• Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF

• Use an Android or Apple smartphone

• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial

• Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff

• Parent/guardian proficient in reading and writing English

• Live in the United States, with no plans to move outside the United States during the study period

Exclusion Criteria

• A1C >10%

• One or more episodes of severe hypoglycemia or DKA requiring ER visit or hospitalization within the past three months

• Used non-insulin anti-diabetic medication within the last 30 days other than metformin

• Known history of gastroparesis, seizure disorder, adrenal insufficiency, or ongoing renal or hepatic disease

• Pregnancy or lactation

• Untreated or unstable hypothyroidism

• Currently undergoing cancer treatment or systemic treatment with steroids

• Untreated or inadequately treated mental illness

• Current alcohol abuse

• Current illness that would interfere with participation in the study

• Delayed gastric emptying or any concurrent conditions that can be associated with delayed gastric emptying or altered digestion; and the use of any medication that affects gastric emptying

• Celiac Disease

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Extended bolus of insulin then standard bolus of insulin
For a standardized HFHP breakfast, participants will receive an extended meal bolus of insulin on the first morning and a standard meal bolus of insulin on the second morning of the study.
• Standard bolus of insulin then extended bolus of insulin
For a standardized HFHP breakfast, participants will receive a standard bolus of insulin on the first morning and an extended bolus of insulin on the second morning of the study.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Area Under Curve [AUC]	Area under the curve between glucose trace and starting glucose (mg/dL* hour)	Baseline and 5 hours post-bolus
Secondary	Percentage of time between 70-180 mg/dL	Percentage of time spent between 70-180 mg/dl based on Continuous Glucose Monitor (CGM) values	Baseline and 5 hours post-bolus
Secondary	Percentage of time in hypoglycemic range (defined as < 70 mg/dL)	Percentage of time spent with blood sugar less than 70 mg/dL based on Continuous Glucose Monitor (CGM) values	Baseline and 5 hours post-bolus
Secondary	Average glucose	Average glucose value based on Continuous Glucose Monitor (CGM) values	Baseline and 5 hours post-bolus
Secondary	Percentage of time in hyperglycemic range (defined as =180 mg/dL);	Percentage of time spent with blood sugar higher than 180 mg/dL based on Continuous Glucose Monitor (CGM) values	Baseline and 5 hours post-bolus
Secondary	Insulin dosage	Total insulin received during 5 hrs ( manual bolus as well as automated)	Baseline and 5 hours post-bolus
Secondary	Time to target	Time spent till blood glucose returns to range	Baseline and 5 hours post-bolus
Secondary	Time to baseline	Time spent till blood glucose returns to baseline	Baseline and 5 hours post-bolus
Secondary	Time to peak glucose	Time spent till blood glucose reaches the maximum value after meal	Baseline and 5 hours post-bolus
Secondary	Change in glucose	The difference between baseline to max glucose value	Baseline and 5 hours post-bolus
Secondary	Peak glucose concentration	Max blood glucose	Baseline and 5 hours post-bolus
Secondary	Percentage of time between 70-140 mg/dL	Percent of glucose readings from CGM system between 70-140 mg/dL per unit of time	Baseline and 5 hours post-bolus