N/A
Completed N=22
Extended Bolus for Meals in a Closed-loop System
Type 1 Diabetes
Source: ClinicalTrials.gov NCT05454891 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Glucose Area Under Curve [AUC] — 45371.8; 48641.5 (mg/dL* min)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Area Under Curve [AUC] |
45371.8; 48641.5 | — |
| SECONDARY Percentage of Time Between 70-180 mg/dL |
73.6; 71.3 | — |
| SECONDARY Percentage of Time in Hypoglycemic Range (Defined as < 70 mg/dL) |
0.0; 0.0 | — |
| SECONDARY Average Glucose |
151.1; 161.7 | — |
| SECONDARY Percentage of Time in Hyperglycemic Range (Defined as ≥180 mg/dL); |
26.0; 28.7 | — |
| SECONDARY Insulin Dosage |
15.9; 15.4 | — |
| SECONDARY Time to Target (110mg/dL) |
294.2; 284.3 | — |
| SECONDARY Time to Baseline |
294.2; 285.2 | — |
| SECONDARY Time to Peak Glucose |
204.7; 160.3 | — |
| SECONDARY Change in Glucose |
80.1; 72.3 | — |
| SECONDARY Peak Glucose Concentration |
203.4; 199.1 | — |
| SECONDARY Percentage of Time Between 70-140 mg/dL |
41.5; 34.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05454891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.