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Trial · Interventional

CompletedPhase 4Registry data

Dual-hormone Closed-loop Glucose Control in Type 1 Diabetes

Short name DHCL2019

NCTNCT04053712 (opens ClinicalTrials.gov in a new tab)Other idH-19026331Other id2019-001631-31Other id2019043528Other id2019043269
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Overview

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

Denmark

Start
16 Jul 2019
Primary completion
19 Mar 2021
Completion
19 Mar 2021
First posted
12 Aug 2019
Last update posted
18 Aug 2022
Conditions
Type 1 Diabetes · Hypoglycemia

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 4

    DHCL2019

    NCT04053712

    16 Jul 2019 to 19 Mar 2021

Registry summary

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

Despite recent pharmacological and technological advantages, hypoglycemia remains to be the key limiting factor in achieving optimal glycemic control in people with type 1 diabetes. State-of-the-art treatment for type 1 diabetes is insulin in pens or pumps that focus on reducing hyperglycemia after relative insulin deficiency e.g. after food intake. In recent years, we focused on adding low-dose glucagon to insulin therapies for the treatment and prevention of hypoglycemia - referred to as "dual-hormone treatment". We have shown that low-dose glucagon is efficient in treating mild hypoglycemia and that several factors may affect its glucose response. Our next step is to test whether the combined delivery of insulin and glucagon can improve glucose control in individuals with type 1 diabetes. In this proposal, we want to test the efficacy, safety and feasibility of a dual-hormone closed-loop system, also known as an artificial pancreas. The closed-loop system involves automatic infusion of glucagon and insulin based on continuous glucose measurements. The system will be tested in a 33-hour in-clinic study comparing the glucose control by the combined automatic delivery of insulin and glucagon with the automatic delivery of insulin-only. The study is performed at Steno Diabetes Center Copenhagen (SDCC) in collaboration with the Technical University of Denmark (DTU). We expect that the study will clarify whether low-dose glucagon added to insulin therapy can improve the glucose control in adults with type 1 diabetes. We believe that the utilization of glucagon will allow for a weight neutral optimization of glucose control, reduce risk of hypoglycemia and reduce disease burden that will reduce diabetes complications and cardiovascular diseases.

Interventions

  • GlucagonDrug
  • Closed-loop systemDevice

Arms2

  • Placebo comparator

    Single-hormone

    FiAsp (R) - Saline

  • Active comparator

    Dual-hormone

    FiAsp(R) - GlucaGen(R)

Primary outcomes2

Outcomes the sponsor listed as primary.

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

    Time frame · 33 hours

  2. Number of carbohydrate interventions to treat hypoglycemia

    Time frame · 33 hours

    Registry description

    Carbohydrate interventions are predefined and provided in case of hypoglycemia

Secondary outcomes(20)

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

    Time frame · 33 hours

    Registry description

    Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.

  2. Percentage of participants achieving (A) time in range (3.9-10 mmol/l) > 70 %, (B) time in alert hypoglycemia (<3.9 mmol/l) < 4 %, and (C) time in clinical hypoglycemia (<3.0 mmol) < 1% as measured by glucose sensor and venous plasma glucose

    Time frame · 33 hours

    Registry description

    A composite outcome will be calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.

  3. Mean blood glucose value measured by glucose sensor and venous plasma glucose

    Time frame · 33 hours

    Registry description

    Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.

  4. Percentage of time with glucose values in the range 3.9-8.0 mmol/l measured by glucose sensor and venous plasma glucose

    Time frame · 33 hours

    Registry description

    Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.

  5. Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by glucose sensor and venous plasma glucose

    Time frame · 33 hours

    Registry description

    Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.

  6. Percentage of time with glucose values in the range > 13.9 measured by glucose sensor and venous plasma glucose

    Time frame · 33 hours

    Registry description

    Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.

  7. Percentage of time with glucose values < 3.0 mmol/l as measured by glucose sensor and venous plasma glucose

    Time frame · 33 hours

    Registry description

    Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.

  8. Number of hypoglycemic episodes (<3.9 mmol/l and <3.0 mmol/l) overnight and during daytime

    Time frame · 33 hours

  9. Nadir blood glucose value for each hypoglycemic episode as measured by glucose sensor and venous plasma glucose

    Time frame · 33 hours

  10. Glucose sensor glycemic variability measured as SD and CV during overnight and during daytime

    Time frame · 33 hours

    Registry description

    Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.

  11. Low Blood Glucose Index (LBGI) overnight and during daytime by glucose sensor and venous plasma glucose

    Time frame · 33 hours

    Registry description

    Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.

  12. Percentage of participants with a mean blood glucose value (glucose sensor and venous plasma glucose) ≤ 8.6 mmol/l (corresponding to an estimated HbA1c of 7.0% / 53 mmol/mol)

    Time frame · 33 hours

  13. Percentage of patients with a mean blood glucose value (glucose sensor and venous plasma glucose) ≤ their standard therapy mean glucose value (calculated based on HbA1c measurement)

    Time frame · 33 hours

  14. Mean Absolute Relative Difference (MARD) between glucose sensor and venous plasma glucose

    Time frame · 33 hours

    Registry description

    Participants have two glucose sensors during the study

  15. Percentages of values between glucose sensor and venous plasma glucose in zone A, B, C, D and E in the Clarke Error Grid analysis.

    Time frame · 33 hours

    Registry description

    Participants have two glucose sensors during the study. One sensor closed to the infusion of glucagon.

  16. Mean blood pressure over the study period (mmHG)

    Time frame · 33 hours

    Registry description

    Blood pressure and pulse taken at predefined timepoints

  17. Mean pulse rate over the study period (beats per min)

    Time frame · 33 hours

    Registry description

    Blood pressure and pulse taken at predefined timepoints

  18. Mean nausea level measured with a visual analog scale (VAS range: 0-10)

    Time frame · 33 hours

    Registry description

    Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.

  19. Total insulin dose per study day (UI)

    Time frame · 33 hours

  20. Total time of insulin suspension per study day (UI)

    Time frame · 33 hours

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 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria * Age ≥ 18 years * T1D ≥ 2 years * Insulin pump therapy ≥ 1 * Currently treated with FiAsp® - insulin * HbA1c ≤ 8.5% (69 mmol/mol) Exclusion criteria * Pregnancy or nursing * Inability and willingness to comply with all protocol procedures, e.g. exercise, sleeping, blood sampling, and meal consumption * Plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection) * Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is \< 3.0 mmol/l) * Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation * History of coronary artery disease or congestive heart failure * Abnormal ECG suggestive of coronary artery disease and increased risk of malignant arrhythmia * Allergy to glucagon or lactose * Pheochromocytoma * Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation Withdrawal criteria * In case of pregnancy (or desire for pregnancy), female subjects are withdrawn * Lack of compliance to any of the important study procedures in the discretion of the investigator * Unacceptable adverse effects in the discretion of the investigator * Withdrawal on participants request will be accepted at any time without further justification Patients who complete or withdraw from the study continue their usual quarterly follow-up visits at the diabetes clinic. Withdrawal does not affect their statutory patient rights.

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