Type 1 Diabetes
Conditions
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.
Interventions
DEVICETandem t:slim X2 insulin pump: 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.
DEVICETandem t:slim X2 insulin pump: 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.
Sponsors
University of California, San Francisco
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Area Under Curve [AUC] | 0 to 5 hours post-meal onset | Area under the curve between glucose trace and starting glucose (mg/dL\* min) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time Between 70-180 mg/dL | 0 to 5 hours post-meal onset | 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) | 0 to 5 hours post-meal onset | Percentage of time spent with blood sugar less than 70 mg/dL based on Continuous Glucose Monitor (CGM) values |
| Average Glucose | 0 to 5 hours post-meal onset | Average glucose value based on Continuous Glucose Monitor (CGM) values |
| Percentage of Time in Hyperglycemic Range (Defined as ≥180 mg/dL); | 0 to 5 hours post-meal onset | Percentage of time spent with blood sugar higher than 180 mg/dL based on Continuous Glucose Monitor (CGM) values |
| Insulin Dosage | 0 to 5 hours post-meal onset | Total insulin received during 5 hrs ( manual bolus as well as automated) |
| Time to Target (110mg/dL) | 0 to 5 hours post-meal onset | Time spent till blood glucose returns to 110mg/dL |
| Time to Baseline | 0 to 5 hours post-meal onset | Time spent till blood glucose returns to baseline |
| Time to Peak Glucose | 0 to 5 hours post-meal onset | Time spent till blood glucose reaches the maximum value after meal |
| Change in Glucose | 0 to 5 hours post-meal onset | The difference between baseline to max glucose value |
| Peak Glucose Concentration | 0 to 5 hours post-meal onset | Max blood glucose |
| Percentage of Time Between 70-140 mg/dL | 0 to 5 hours post-meal onset | Percent of glucose readings from CGM system between 70-140 mg/dL per unit of time |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaya Ekhlaspour, MD
University of California, San Francisco
Participant flow
Pre-assignment details
A total of 30 participants were enrolled. Three participants were screen failures. Of the remaining 27 eligible participants, 22 were randomized and 5 withdrew or were withdrawn prior to randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 18 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 1 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
None listed