N/A
Completed N=21
Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes
Source: ClinicalTrials.gov NCT04545567 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal — 83; 53 %Time in Range (TIR) — p=0.004
Summary
The study team will be comparing two investigational Artificial Pancreas (AP) systems that the UVA Center for Diabetes Technology has developed. An artificial pancreas system delivers insulin automatically based on a blood glucose level that is provided from a continuous glucose monitor (CGM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range 70-180 mg/dL in the Unannounced Meal |
83; 53 | 0.004 sig |
| SECONDARY Number of Hypoglycemia Events From Dinner Time Until Midnight |
0; 0 | 0.26 |
| SECONDARY Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range < 70 mg/dL |
0; 0 | 0.2 |
| SECONDARY Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >180 mg/dL |
17; 47 | 0.01 sig |
| SECONDARY Percentage of Time From Dinner Time Until Midnight With Blood Glucose in Range >250 mg/dL |
0; 0 | 1 |
| SECONDARY Units of Insulin Injected From Dinner Time Until Midnight |
15; 14 | 0.21 |
| SECONDARY The Blood Glucose Area Under the Curve (AUC) From Dinner Until Midnight, Accounting for the Initial Blood Glucose Value |
27052; 25840 | 0.05 |
| SECONDARY Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range 70-180 mg/dL |
90; 75 | <0.001 sig |
| SECONDARY Number of Hypoglycemia Events From Dinner Time Until Dinner Time + 12h |
0; 0 | 0.41 |
| SECONDARY Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose in Range <70 mg/dL |
0; 0 | 0.54 |
| SECONDARY Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >180 mg/dL |
8.7; 25 | 0.003 sig |
| SECONDARY Percentage of Time From Dinner Time Until Dinner Time + 12h With Blood Glucose >250 mg/dL |
0; 0 | 0.52 |
| SECONDARY Units of Insulin Injected From Dinner Time Until Dinner Time + 12h |
21; 20 | 0.28 |
| SECONDARY The Blood Glucose Area Under the Curve (AUC) From Dinner Until Dinner + 12h, Accounting for the Initial Blood Glucose Value |
38891; 40671 | 0.05 |
| SECONDARY Percentage of Time Outside the Dinner Sessions With Blood Glucose in Range 70-180 mg/dL |
86; 81 | 0.007 sig |
| SECONDARY Number of Hypoglycemia Events Outside of the Study Dinner Sessions |
3; 4.5 | 0.14 |
| SECONDARY Percentage of Time Outside of the Study Dinner Sessions With Blood Glucose <70 mg/dL |
2.2; 2.9 | 0.22 |
| SECONDARY Percent of Time Outside of the Study Dinner Sessions With Blood Glucose >180 mg/dL |
9.5; 14 | 0.03 sig |
| SECONDARY Percent Time Outside of the Study Dinner Sessions With Blood Glucose >250 mg/dL |
0; 0 | 0.49 |
| SECONDARY Units of Insulin Injected Outside of the Study Dinner Sessions |
78; 85 | 0.01 sig |
Eligibility Criteria
Inclusion Criteria
- Age ≥12.0 and ≤25 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
- Currently using insulin for at least six months
- Currently using insulin pump for at least three months
- Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
- Access to internet and willingness to upload data during the study as needed
- For females, not currently known to be pregnant or breastfeeding
- If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
- Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
- Willingness to use the UVa artificial pancreas system throughout study sessions.
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/d
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- Willingness to eat at least 1 g/kg of carbohydrate per day during the camp/hotel admission
- Willingness to reschedule Study Dinner Sessions if placed on oral steroids
- An understanding and willingness to follow the protocol and signed informed consent
Exclusion Criteria
- History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
- Pregnancy or intent to become pregnant during the trial
- Currently being treated for a seizure disorder
- Planned surgery during study duration
- Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals)
- A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
- Use of an automated insulin delivery mechanism that is not downloadable by the subject or study team
Data sourced from ClinicalTrials.gov (NCT04545567). 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.