Extended Bolus for Meals in a Closed-loop System
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ClinicalTrials.gov Identifier: NCT05454891 |
Recruitment Status :
Recruiting
First Posted : July 12, 2022
Last Update Posted : April 10, 2024
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Condition or disease | Intervention/treatment | Phase |
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Type 1 Diabetes | Drug: Extended bolus of insulin then standard bolus of insulin Drug: Standard bolus of insulin then extended bolus of insulin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention 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) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | July 15, 2022 |
Estimated Primary Completion Date : | July 30, 2024 |
Estimated Study Completion Date : | September 30, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: High Fat High Protein (HFHP) Meal- extended then standard insulin bolus arm
Subjects will receive extended meal bolus for breakfast on the first day and standard meal bolus on the second day of the study.
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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. |
Experimental: High Fat High Protein (HFHP) Meal- standard then extended insulin bolus arm
Subjects will receive standard meal bolus for breakfast on the first day and extended meal bolus on the second day.
|
Drug: 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. |
- Glucose Area Under Curve [AUC] [ Time Frame: Baseline and 5 hours post-bolus ]Area under the curve between glucose trace and starting glucose (mg/dL* hour)
- Percentage of time between 70-180 mg/dL [ Time Frame: Baseline and 5 hours post-bolus ]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) [ Time Frame: Baseline and 5 hours post-bolus ]Percentage of time spent with blood sugar less than 70 mg/dL based on Continuous Glucose Monitor (CGM) values
- Average glucose [ Time Frame: Baseline and 5 hours post-bolus ]Average glucose value based on Continuous Glucose Monitor (CGM) values
- Percentage of time in hyperglycemic range (defined as ≥180 mg/dL); [ Time Frame: Baseline and 5 hours post-bolus ]Percentage of time spent with blood sugar higher than 180 mg/dL based on Continuous Glucose Monitor (CGM) values
- Insulin dosage [ Time Frame: Baseline and 5 hours post-bolus ]Total insulin received during 5 hrs ( manual bolus as well as automated)
- Time to target [ Time Frame: Baseline and 5 hours post-bolus ]Time spent till blood glucose returns to range
- Time to baseline [ Time Frame: Baseline and 5 hours post-bolus ]Time spent till blood glucose returns to baseline
- Time to peak glucose [ Time Frame: Baseline and 5 hours post-bolus ]Time spent till blood glucose reaches the maximum value after meal
- Change in glucose [ Time Frame: Baseline and 5 hours post-bolus ]The difference between baseline to max glucose value
- Peak glucose concentration [ Time Frame: Baseline and 5 hours post-bolus ]Max blood glucose
- Percentage of time between 70-140 mg/dL [ Time Frame: Baseline and 5 hours post-bolus ]Percent of glucose readings from CGM system between 70-140 mg/dL per unit of time
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Ages Eligible for Study: | 13 Years to 19 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05454891
Contact: Laya Ekhlaspour, MD | 415-514-8531 | laya.ekhlaspour@ucsf.edu | |
Contact: Rebecca Wesch | (415) 476-5984 | Rebecca.wesch@ucsf.edu |
United States, California | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94158 | |
Contact: Rebecca Wesch |
Principal Investigator: | Laya Ekhlaspour, MD | University of California, San Francisco |
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT05454891 |
Other Study ID Numbers: |
58992 5K23DK121942-02 ( U.S. NIH Grant/Contract ) |
First Posted: | July 12, 2022 Key Record Dates |
Last Update Posted: | April 10, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Diabetes Mellitus, Type 1 Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin Insulin, Globin Zinc Hypoglycemic Agents Physiological Effects of Drugs |