N/A
Completed N=93
Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT02679287 ↗
Enrolled (actual)
93
Serious AEs
0.8%
Results posted
Jun 2020
Primary outcomePrimary: Time <70 mg/dl by CGM — 4.0; 2.2 percentage of time — p=<0.0001
Summary
The purpose of this study is to use an investigational type of technology called Closed-Loop Control (CLC) Medical Platform System to help control blood sugar in people with type 1 diabetes mellitus in a home setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time <70 mg/dl by CGM |
4.0; 2.2 | <0.0001 sig |
| PRIMARY Hemoglobin A1c |
7.42; 7.11 | — |
| SECONDARY Time Between 70-180 mg/dL by CGM |
58.6; 67.6; 69.5 | — |
| SECONDARY Time >180 mg/dL by CGM |
37.4; 30.1; 28.7 | — |
| SECONDARY Mean Glucose by CGM |
9.3; 8.82; 8.74 | — |
| SECONDARY Low Blood Glucose Index (LBGI) |
1.04; 0.66; 0.57 | — |
| SECONDARY High Blood Glucose Index (HBGI) |
8.82; 6.97; 6.53 | — |
| SECONDARY CGM <70mg/dL |
4.0; 2.3; 1.8 | — |
| SECONDARY Hemoglobin A1c by Study Session |
7.3; 7.01; 7.12; 6.95; 7.13; 7.06 | — |
Eligibility Criteria
Inclusion Criteria
- type 1 diabetes for at least one year
- using insulin for at least 1 year
- an insulin pump for at least 6 months
- willingness to switch to lispro (Humalog) or aspart (Novolog) if using glulisine (Apidra).
Exclusion Criteria
- a medical condition or being been treated with medications that might interfere with the study
Data sourced from ClinicalTrials.gov (NCT02679287). 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.