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

NCT04949867 | Completed Phase 4 DMC

• 4 other identifiers: H-210002072020-005836-312021-0409-34PD002-19
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief 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

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  Percentage

  26 hours during closed-loop control

Secondary Outcomes (21)

• Number of carbohydrate interventions to treat hypoglycemia

  26 hours during closed-loop control

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

  26 hours during closed-loop control

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

  26 hours during closed-loop control

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

  26 hours during closed-loop control

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

  26 hours during closed-loop control

Study Arms (2)

Dual-hormone Closed-loop

ACTIVE COMPARATOR

FiAsp® and GlucaGen®.

Drug: Glucagon; Device: Closed-loop System

Single-Hormone Closed-loop

PLACEBO COMPARATOR

FiAsp® and isotonic saline.

Device: Closed-loop System

Interventions

Glucagon DRUG

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

Also known as: GlucaGen, Novo Nordisk,

Dual-hormone Closed-loop

Closed-loop System DEVICE

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.

Also known as: Saline

Dual-hormone Closed-loop; Single-Hormone Closed-loop

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Technical University of Denmark: collaborator
• Herlev Hospital: collaborator

Study Sites (2)

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

Location

Herlev Hospital

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucagon; Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Glucagon-Like Peptides; Gastrointestinal Hormones

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: . For dual-hormone control, the study pumps will be filled with FiAsp® and GlucaGen®. For single-hormone control, the study pumps have been filled with FiAsp® and isotonic saline. Pump filling is conducted before the participant arrives at the research facility. The glucagon/saline pump and the insulin pump are clearly marked and cannot be confused. The participants are blinded to the treatment, as isotonic saline by its looks is indistinguishable from GlucaGen®. The placebo pump ('dummy' pump) will not infuse the saline and cannot be detected by the participant.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized, single-blinded, cross-over study of glycemic control during dual-hormone therapy compared with single-hormone therapy in adolescents with type 1 diabetes.

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: July 2, 2021
• Study Start: May 20, 2021
• Primary Completion: April 26, 2022
• Study Completion: April 26, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: From 1 year to 10 years after completion

Locations

DK (2)