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NCT04878120

Hybrid Closed-Loop Control With Smart Prandial Insulin Dosing in Type 1 Diabetes

Completed NA Results posted Last updated 30 May 2024
What this trial tests

NA trial testing Standard HCL System in Type 1 Diabetes in 25 participants. Completed in 28 June 2022.

Timeline
14 May 2021
Primary endpoint
24 June 2022
28 June 2022

Quick facts

Lead sponsorUniversity of Virginia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment25
Start date14 May 2021
Primary completion24 June 2022
Estimated completion28 June 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Virginia

Who can join

Adults 12 to 17, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Low Blood Glucose Index (LBGI) Primary · 4 hours (dinner postprandial period); the final metric for each intervention type is obtained as the average over two consecutive camp days (days 1-2 for the first intervention; days 3-4 for the second intervention)

LBGI computed from CGM collected in the four hours following the dinner meal. LBGI is a metric quantifying the risk for hypoglycemia (the higher the LBGI, the higher the exposure to/risk of hypoglycemia), calculated based on the following two steps: 1. Transforming each CGM reading in the time-series of length N into a hypoglycemia risk score (rL(i), i=1,...,N) by applying the following transformation: rL(i) = 10 x (1.509 x (log(CGM(i))\^1.084 - 5.381))\^2, if CGM(i) \<=112.5 mg/dL; rL(i) = 0, if CGM(i) \>112.5 mg/dL 2. Averaging the risk scores rL(i), i=1,...,N. The hypoglycemia risk s

Camp days 1-2
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator2.87± 2.59
HCL Control With Smart Bolus Calculator - Standard HCL Control3.19± 1.73
Camp days 3-4
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator1.1± 0.78
HCL Control With Smart Bolus Calculator - Standard HCL Control1.70± 0.79
Percentage of Time Spent Below 70 mg/dL Secondary · 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome

Percentage of CGM readings in hypoglycemia below 70 mg/dL

Camp days 1-2
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator10.33± 14.55
HCL Control With Smart Bolus Calculator - Standard HCL Control12.08± 7.88
Camp days 3-4
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator2.31± 3.16
HCL Control With Smart Bolus Calculator - Standard HCL Control5.00± 3.61
Percentage of Time Spent in 70-180 mg/dL Secondary · 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome

Percentage of CGM readings in normoglycemia between 70-180 mg/dL

Camp days 1-2
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator83.16± 14.40
HCL Control With Smart Bolus Calculator - Standard HCL Control78.16± 20.98
Camp days 3-4
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator81.47± 15.30
HCL Control With Smart Bolus Calculator - Standard HCL Control85.44± 17.73
Percentage of Time Spent Above 180 mg/dL Secondary · 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome

Percentage of CGM readings in hyperglycemia above 180 mg/dL

Camp days 1-2
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator6.51± 9.69
HCL Control With Smart Bolus Calculator - Standard HCL Control9.76± 21.25
Camp days 3-4
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator16.22± 16.37
HCL Control With Smart Bolus Calculator - Standard HCL Control9.56± 17.63
High Blood Glucose Index (HBGI) Secondary · 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome

HBGI computed from CGM collected in the four hours following the dinner meal. HBGI is a metric quantifying the risk for hyperglycemia (the higher the HBGI, the higher the exposure to/risk of hyperglycemia), calculated based on the following two steps: 1. Transforming each CGM reading in the time-series of length N into a hyperglycemia risk score (rH(i), i=1,...,N) by applying the following transformation: rH(i) = 10 x (1.509 x (log(CGM(i))\^1.084 - 5.381))\^2, if CGM(i) \>112.5 mg/dL; rH(i) = 0, if CGM(i) \<=112.5 mg/dL 2. Averaging the risk scores rH(i), i=1,...,N. The hyperglycemia ri

Camp days 1-2
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator1.64± 1.73
HCL Control With Smart Bolus Calculator - Standard HCL Control3.51± 8.45
Camp days 3-4
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator4.10± 4.74
HCL Control With Smart Bolus Calculator - Standard HCL Control1.85± 2.60
CGM Coefficient of Variation Secondary · 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome

CGM coefficient of variation as a measure of glucose variability

Camp days 1-2
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator25.36± 5.81
HCL Control With Smart Bolus Calculator - Standard HCL Control25.74± 8.69
Camp days 3-4
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator24.01± 5.14
HCL Control With Smart Bolus Calculator - Standard HCL Control21.74± 5.81
Total Amount of Carbohydrate Administered as Rescue Treatments Secondary · 4 hour (dinner postprandial period); average over two consecutive days for each intervention type, as described for primary outcome

Total amount of carbohydrate administered as rescue treatments per study protocol

Camp days 1-2
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator29.75± 25.11
HCL Control With Smart Bolus Calculator - Standard HCL Control37.45± 23.51
Camp days 3-4
GroupValue95% CI
Standard HCL Control - HCL Control With Smart Bolus Calculator11.54± 10.69
HCL Control With Smart Bolus Calculator - Standard HCL Control20.41± 14.56

Adverse events — posted to ClinicalTrials.gov

Time frame: About six months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard HCL Control
Serious: 0/25 (0%)
Deaths: 0/25
HCL Control With Smart Bolus Calculator
Serious: 0/25 (0%)
Deaths: 0/25
Other adverse events (2 terms — click to expand)

ReactionSystemStandard HCL ControlHCL Control With Smart Bol…
VomitingGeneral disorders——
Sore ThroatGeneral disorders——

Data from ClinicalTrials.gov NCT04878120 adverse events section.

Sponsor's own description

The objective of this study is to evaluate the safety and feasibility of a smart bolus calculator that adjusts insulin dosing for meals according to real-time insulin sensitivity (SI) in adolescents with type 1 diabetes (T1D) using a hybrid closed loop (HCL) system during an active week of diabetes camp.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

Other University of Virginia trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04878120.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing