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Trial · Interventional

CompletedPhase 4Registry data

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

Short name DHCL2021

NCTNCT04949867 (opens ClinicalTrials.gov in a new tab)Other idH-21000207Other id2020-005836-31Other id2021-0409-34Other idPD002-19
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
11 participants (actual)
Sponsor
Steno Diabetes Center Copenhagen · Other
Design
Randomized · Single masking
Countries
1 country

Denmark

Start
20 May 2021
Primary completion
26 Apr 2022
Completion
26 Apr 2022
First posted
2 Jul 2021
Last update posted
18 Aug 2022
Conditions
Type 1 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 4

    DHCL2021

    NCT04949867

    20 May 2021 to 26 Apr 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • GlucagonDrug
  • Closed-loop SystemDevice

Arms2

  • Active comparator

    Dual-hormone Closed-loop

    FiAsp® and GlucaGen®.

  • Placebo comparator

    Single-Hormone Closed-loop

    FiAsp® and isotonic saline.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of time with glucose values < 3.9 mmol/l as measured by the continuous glucose monitor

    Time frame · 26 hours during closed-loop control

    Registry description

    Percentage

Secondary outcomes(20)

  1. Number of carbohydrate interventions to treat hypoglycemia

    Time frame · 26 hours during closed-loop control

  2. Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by continuous glucose monitor and plasma glucose

    Time frame · 26 hours during closed-loop control

    Registry description

    Percentage

  3. Percentage of time with glucose values < 3.9 mmol/l as measured by plasma glucose

    Time frame · 26 hours during closed-loop control

    Registry description

    Percentage

  4. Percentage of time with glucose values in the range > 13.9 mmol/l measured by continuous glucose monitor and plasma glucose

    Time frame · 26 hours during closed-loop control

    Registry description

    Percentage

  5. Percentage of time with glucose values < 3.0 mmol/l as measured by continuous glucose monitor and plasma glucose

    Time frame · 26 hours during closed-loop control

    Registry description

    Percentage

  6. Mean blood glucose value measured by continuous glucose monitor and plasma glucose

    Time frame · 26 hours during closed-loop control

    Registry description

    mmol/L

  7. Number of hypoglycemic episodes < 3.9 mmol/l on continuous glucose monitor and plasma glucose

    Time frame · 26 hours during closed-loop control

    Registry description

    No.

  8. Continuous glucose monitored glycemic variability measured as SD

    Time frame · 26 hours during closed-loop control

    Registry description

    mmol/L

  9. Continuous glucose monitored glycemic variability measured as CV

    Time frame · 26 hours during closed-loop control

    Registry description

    percentage

  10. Composite outcome: Percentage of participants achieving (1) time in range (3.9-10) > 70 %, (2) time in alert hypoglycemia (<3.9 mmol/l) < 4 %, and (3) time in clinical hypoglycemia (<3.0 mmol) < 1% as measured by CGM and YSI

    Time frame · 26 hours during closed-loop control

    Registry description

    percentage

  11. Total insulin dose

    Time frame · 26 hours during closed-loop control

    Registry description

    units

  12. Total glucagon dose

    Time frame · 26 hours during closed-loop control

    Registry description

    mg

  13. Number of manual insulin boluses

    Time frame · 26 hours during closed-loop control

    Registry description

    No.

  14. Number of adverse events - Nausea

    Time frame · 26 hours during closed-loop control

    Registry description

    No of event if visual analog scale (0-100) increase \>10 from baseline

  15. Number of adverse events - Headache

    Time frame · 26 hours during closed-loop control

    Registry description

    No of event if visual analog scale (0-100) increase \>10 from baseline

  16. Number of adverse events - Palpitation

    Time frame · 26 hours during closed-loop control

    Registry description

    No of event if visual analog scale (0-100) increase \>10 from baseline

  17. Number of vomits

    Time frame · 26 hours during closed-loop control

    Registry description

    No of event if visual analog scale (0-100) increase \>10 from baseline

  18. Difference between actual and participant-estimated carbohydrate content in meals

    Time frame · 26 hours of closed-loop glucose control

    Registry description

    g per meal

  19. Mean Borg scale

    Time frame · During 45 minutes exercise

    Registry description

    Scale of perceived exertion from 6 (no effort activity) to 20 (max effort activity)

  20. Physical activity intensity measured by ActiGraph GT9X Link

    Time frame · 26 hours

    Registry description

    Percentage of sedentary activity

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 13 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age = 13-17 years * T1D duration ≥ 2 years * Insulin pump therapy ≥ 1 year * Using CGM or isCGM (Flash Libre) * HbA1c ≤ 9.0% (75 mmol/mol) * Using carbohydrate counting Exclusion Criteria: * Allergy to glucagon or lactose * Allergy to faster insulin aspart (FiAsp) * Pheochromocytoma * Self-reported lack of hypoglycemia symptoms when blood glucose is \< 3.0 mmol/l * Inability to follow study procedures, e.g. exercise, sleeping, blood sampling, and meal intake * Pregnancy, nursing, plan to become pregnant or sexually active and not using adequate contraceptive methods (intrauterine device, contraceptive pill, patch or injection) * Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation * Other concomitant medical or psychological condition that according to the investigator's assessment makes the participant unsuitable for study participation

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