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Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes

NCT04949867 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-08-18

No results posted yet for this study

Summary

Objective:

To assess the efficacy and safety of an insulin-glucagon dual-hormone (DH) closed-loop system compared with an insulin-only single-hormone (SH) closed-loop system in adolescent with type 1 diabetes.

Methods:

In a 26-h, randomized, crossover, inpatient study, 20 children and adolescents with type 1 diabetes used two modes of the DiaCon Artificial Pancreas system: DH and SH closed-loop control. During each study period, participants will have one overnight stay, received three meals and performed exercise for 45 min (bicycle with estimated 50% V02max).

Endpoint:

The primary endpoint is sensor-derived percentage of time in hypoglycemia (\<3.9 mmol/L).

Conditions

Interventions

DRUG

Glucagon

Glucagon is filled in the pump and given automatically in case of hypoglycemia or pending hypoglycemia.

DEVICE

Closed-loop System

Closed-loop system comprise of two DANA RS (R) insulin pumps (FiAsp-GlucaGen vs FiAsp-saline), one DexCom G6 sensor, and a smartphone for the control algorithm.

Sponsors & Collaborators

  • Technical University of Denmark

    collaborator OTHER

  • Herlev Hospital

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2022-04-26
Completion
2022-04-26

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04949867 on ClinicalTrials.gov