N/A
Completed N=33
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Source: ClinicalTrials.gov NCT05204134 ↗Enrolled (actual)
33
Serious AEs
3.0%
Results posted
Apr 2024
Primary outcomePrimary: Severe Hypoglycemic Events — 0; 0.06 number of events
Summary
Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severe Hypoglycemic Events |
0; 0.06 | — |
| PRIMARY Diabetic Ketoacidosis Events |
0; 0 | — |
| SECONDARY Percent Time < 54 mg/dL, Overall |
0.3; 0.2 | 0.06 |
| SECONDARY Percent Time < 54 mg/dL, Daytime Outcomes |
0.2; 0.2 | 0.11 |
| SECONDARY Percent Time < 54 mg/dL, Overnight Outcomes |
0.2; 0.2 | 0.04 sig |
| SECONDARY Percent Time < 70 mg/dL, Overall |
1.8; 1.0 | 0.03 sig |
| SECONDARY Percent Time < 70 mg/dL, Daytime Outcomes |
1.5; 1.1 | 0.26 |
| SECONDARY Percent Time < 70 mg/dL, Overnight Outcomes |
2.1; 1.0 | 0.005 sig |
| SECONDARY Percent of Time 70-140 mg/dL, Overall |
26.0; 39.2 | <0.001 sig |
| SECONDARY Percent of Time 70-140 mg/dL, Daytime Outcomes |
23.8; 39.0 | <0.001 sig |
| SECONDARY Percent of Time 70-140 mg/dL, Overnight Outcomes |
29.4; 45.0 | <0.001 sig |
| SECONDARY Percent of Time 70-180 mg/dL, Overall |
45.7; 69.1 | <0.001 sig |
| SECONDARY Percent of Time 70-180 mg/dL, Daytime Outcomes |
45.5; 65.4 | <0.001 sig |
| SECONDARY Percent of Time 70-180 mg/dL, Overnight Outcomes |
53.5; 74.9 | <0.001 sig |
| SECONDARY Percent Time > 180 mg/dL, Overall |
51.9; 29.5 | <0.001 sig |
| SECONDARY Percent Time > 180 mg/dL, Daytime Outcomes |
52.5; 34.2 | <0.001 sig |
| SECONDARY Percent Time > 180 mg/dL, Overnight Outcomes |
38.7; 24.6 | <0.001 sig |
| SECONDARY Percent Time > 250 mg/dL, Overall |
21.8; 7.7 | <0.001 sig |
| SECONDARY Percent Time > 250 mg/dL, Daytime Outcomes |
19.6; 8.5 | <0.001 sig |
| SECONDARY Percent Time > 250 mg/dL, Overnight Outcomes |
20.1; 6.0 | <0.001 sig |
| SECONDARY Median Sensor Glucose |
185.0; 149.0 | <0.001 sig |
| SECONDARY Total Daily Insulin Use |
55.0; 61.5 | 0.17 |
| SECONDARY Total Daily Bolus Insulin Use |
23.0; 25.3 | 0.03 sig |
| SECONDARY Total Daily Basal Insulin Use |
32.5; 30.1 | 0.69 |
| SECONDARY Physician Overrides/Physician Initiated Changes in Pump Settings |
0.21 | — |
| SECONDARY Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion |
3.5 | — |
| SECONDARY Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion |
8.9 | — |
Eligibility Criteria
Inclusion Criteria
- Adult subjects ≥ age 18 years
- Clinical diagnosis of type 1 diabetes for at least one year
- Using a basal/bolus regimen by injection (MDI therapy)
- Total daily dose ≥10 units/day
- Willing to use only aspart (novolog) or lispro (humalog) U-100 insulin with the study pump.
- A1c ≥ 7.5% and ≤ 11% at screening
- Not pregnant or planning a pregnancy during the time period of the study.
- Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
- Willingness to follow study procedures and a signed informed consent form
Exclusion Criteria
- Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months
- Two or more episodes of diabetic ketoacidosis in the past 6 months
- Inpatient psychiatric treatment in the past 6 months
- History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study
- Significant chronic kidney disease or hemodialysis
- Significant liver disease
- History of adrenal insufficiency
- Hypothyroidism or hyperthyroidism that is not appropriately treated
- Other chronic disease/condition determined by investigator to interfere with participation in the study
- Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study
- Use of long-acting insulin, inhaled insulin (Afrezza), or use of any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than Metformin with the study pump
- Subject is pregnant or lactating or intending to become pregnant before or during participation in this study
- Investigator judgement that subject would not be able to complete the trial
Data sourced from ClinicalTrials.gov (NCT05204134). 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.