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Extended Bolus for Meals in a Closed-loop System

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Extended bolus of insulin then standard bolus of insulin
Standard bolus of insulin then extended bolus of insulin
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Age between 13 and 18 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

Sites / Locations

  • University of California San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High Fat High Protein (HFHP) Meal- extended then standard insulin bolus arm

High Fat High Protein (HFHP) Meal- standard then extended insulin bolus arm

Arm Description

Subjects will receive extended meal bolus for breakfast on the first day and standard meal bolus on the second day of the study.

Subjects will receive standard meal bolus for breakfast on the first day and extended meal bolus on the second day.

Outcomes

Primary Outcome Measures

Glucose Area Under Curve [AUC]
Area under the curve between glucose trace and starting glucose (mg/dL* hour)

Secondary Outcome Measures

Percentage of time between 70-180 mg/dL
Percentage of time spent between 70-180 mg/dl based on Continuous Glucose Monitor (CGM) values
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
Average glucose
Average glucose value based on Continuous Glucose Monitor (CGM) values
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
Insulin dosage
Total insulin received during 5 hrs ( manual bolus as well as automated)
Time to target
Time spent till blood glucose returns to range
Time to baseline
Time spent till blood glucose returns to baseline
Time to peak glucose
Time spent till blood glucose reaches the maximum value after meal
Change in glucose
The difference between baseline to max glucose value
Peak glucose concentration
Max blood glucose
Percentage of time between 70-140 mg/dL
Percent of glucose readings from CGM system between 70-140 mg/dL per unit of time

Full Information

First Posted
June 24, 2022
Last Updated
September 15, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05454891
Brief Title
Extended Bolus for Meals in a Closed-loop System
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Participants will be randomly assigned (1:1) in blocks of two to the order in which they receive the two premeal insulin boluses: extended followed by standard bolus or a standard followed by extended bolus.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Fat High Protein (HFHP) Meal- extended then standard insulin bolus arm
Arm Type
Experimental
Arm Description
Subjects will receive extended meal bolus for breakfast on the first day and standard meal bolus on the second day of the study.
Arm Title
High Fat High Protein (HFHP) Meal- standard then extended insulin bolus arm
Arm Type
Experimental
Arm Description
Subjects will receive standard meal bolus for breakfast on the first day and extended meal bolus on the second day.
Intervention Type
Drug
Intervention Name(s)
Extended bolus of insulin then standard bolus of insulin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard bolus of insulin then extended bolus of insulin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glucose Area Under Curve [AUC]
Description
Area under the curve between glucose trace and starting glucose (mg/dL* hour)
Time Frame
Baseline and 5 hours post-bolus
Secondary Outcome Measure Information:
Title
Percentage of time between 70-180 mg/dL
Description
Percentage of time spent between 70-180 mg/dl based on Continuous Glucose Monitor (CGM) values
Time Frame
Baseline and 5 hours post-bolus
Title
Percentage of time in hypoglycemic range (defined as < 70 mg/dL)
Description
Percentage of time spent with blood sugar less than 70 mg/dL based on Continuous Glucose Monitor (CGM) values
Time Frame
Baseline and 5 hours post-bolus
Title
Average glucose
Description
Average glucose value based on Continuous Glucose Monitor (CGM) values
Time Frame
Baseline and 5 hours post-bolus
Title
Percentage of time in hyperglycemic range (defined as ≥180 mg/dL);
Description
Percentage of time spent with blood sugar higher than 180 mg/dL based on Continuous Glucose Monitor (CGM) values
Time Frame
Baseline and 5 hours post-bolus
Title
Insulin dosage
Description
Total insulin received during 5 hrs ( manual bolus as well as automated)
Time Frame
Baseline and 5 hours post-bolus
Title
Time to target
Description
Time spent till blood glucose returns to range
Time Frame
Baseline and 5 hours post-bolus
Title
Time to baseline
Description
Time spent till blood glucose returns to baseline
Time Frame
Baseline and 5 hours post-bolus
Title
Time to peak glucose
Description
Time spent till blood glucose reaches the maximum value after meal
Time Frame
Baseline and 5 hours post-bolus
Title
Change in glucose
Description
The difference between baseline to max glucose value
Time Frame
Baseline and 5 hours post-bolus
Title
Peak glucose concentration
Description
Max blood glucose
Time Frame
Baseline and 5 hours post-bolus
Title
Percentage of time between 70-140 mg/dL
Description
Percent of glucose readings from CGM system between 70-140 mg/dL per unit of time
Time Frame
Baseline and 5 hours post-bolus

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age between 13 and 18 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laya Ekhlaspour, MD
Phone
415-514-8531
Email
laya.ekhlaspour@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca Wesch
Phone
(415) 476-5984
Email
Rebecca.wesch@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laya Ekhlaspour, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Wesch

12. IPD Sharing Statement

Plan to Share IPD
No

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Extended Bolus for Meals in a Closed-loop System

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