Dual Hormone Closed Loop in Type 1 Diabetes

NCT05669547 | Completed DMC

• 1 other identifier: 22/671
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 14

Brief Summary

This study is a 12 month open-label, two-arm randomised parallel-group trial in adult type 1 diabetes patients executed in 14 centres in the Netherlands. The aim of this study is to determine the long-term clinical effectiveness of treatment with a dual-hormone (insulin and glucagon) fully closed loop system during 12 months compared to the current most used care and to the currently most advanced technological care. Secondary objectives include the assessment of cost-effectiveness, Patient Reported Outcome Measures (PROMs), other glycaemic outcomes and safety.

Conditions

Diabetes type1; Diabetes Mellitus, Type 1; Diabetes

Keywords

dual hormone; fully closed loop; bihormonal pump; artificial pancreas

Outcome Measures

Primary Outcomes (1)

• Time in Range (TIR) at 12 months (measured with an independent FSL Pro IQ sensor)

  TIR (% of time spent in the 3.9-10 mmol/l target range) at 12 months, which will be compared between the intervention and the control treatment within each arm.

  12 months

Secondary Outcomes (20)

• World Health Organization-Five Well-Being Index (WHO-5) score (Patient reported outcomes (PROMs)

  at 0, 3, 6, 9 and 12 months

• Health-related quality of life scores (EQ-5D-5L) (Patient reported outcomes (PROMs)

  at 0, 3, 6, 9 and 12 months

• Problem Areas In Diabetes (PAID-5) score (Patient reported outcomes (PROMs)

  at 0, 3, 6, 9 and 12 months

• Diabetes Treatment and Satisfaction Questionnaire status and change (DTSQ-s and DTSQ-c) scores (Patient reported outcomes (PROMs)

  at 0, 3, 6, 9 and 12 months

• Hypoglycaemia Fear Survey-II (HFS-II) Worry subscale score; (Patient reported outcomes (PROMs)

  at 0, 3, 6, 9 and 12 months

Other Outcomes (8)

• Patient reported daily insulin use control group

  at 3, 6, 9 and 12 months

• Weight (kg) at baseline and 12 months

  12 months

• Blood pressure (SBP/DBP in mmHg) at baseline and 12 months

  12 months

Study Arms (2)

Control

NO INTERVENTION

Patients currently on multiple daily injections (MDI) + continuous or flash glucose monitoring (CGM; FGM) or on a hybrid closed loop (HCL).

Intervention

EXPERIMENTAL

Patients on dual hormone fully closed loop (DHFCL) therapy.

Device: dual hormone fully closed loop (DHFCL)

Interventions

dual hormone fully closed loop (DHFCL) DEVICE

dual hormone fully closed loop consisting of an algorithm, sensors and both insulin and glucagon infusion.

Also known as: Inreda AP (Inreda Diabetic BV)

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years;
• Diagnosed with type 1 diabetes mellitus at least one year ago;
• HbA1c ≤ 91 mmol/mol;
• Treated with either MDI with FGM/CGM or treated with HCL:
• MDI+FGM/CGM for ≥ 3 months with an adequate sensor use during at least 70% of the time in the month prior to screening (based on sensor usage from the download summary report of the FGM/CGM);
• HCL for ≥ 3 months with a frequency of use ≥ 70% of the time in auto mode over the previous month prior to screening;
• Does not reach the treatment goals over the last 8 weeks:
• for MDI+FGM/CGM: subject has a TIR \<80% or Time Below Range (TBR) \>4%;
• for HCL: subject has a TIR \<80% or TBR \>4%;
• Willing to take or switch to insulin Humalog when randomized to the intervention DHFCL arm;
• Under treatment in one of the participating centres;
• Willing and able to sign informed consent;
• Access to internet at home (for DHFCL data upload).

You may not qualify if:

• Current use of non-approved HCL device;
• BMI \>35 kg/m2;
• eGFR\<30 mL/min/1.73m2;
• Plan to change usual diabetes regimen in the next 3 months;
• Current participation in another diabetes-related clinical trial;
• Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrolment into this study, as per investigator judgment;
• Established history of allergy or severe reaction to adhesive or tape that must be used in the study;
• Use of oral glucose-lowering medication;
• Active retinopathy or painful neuropathy;
• Daily use of acetaminophen during the trial (all arms), as this may influence the sensor glucose measurements. Incidental use with a maximum of e.g. 3 daily doses of 1000mg paracetamol for a maximum of 3 consecutive days is allowed
• Limited ability to see, and to hear or feel alarm signals of the closed loop system;
• Current pregnancy, breast feeding or planning to become pregnant in the 12 months of the trial or using ineffective birth control methods;
• Presence of a medical or psychiatric condition, longstanding serious adherence problems, anticipated problems in handing over diabetes control to a device or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant.

Sponsors & Collaborators

• UMC Utrecht: lead
• Dutch National Health Care Institute: collaborator
• Inreda Diabetic B.V.: collaborator

Study Sites (14)

Meander MC

Amersfoort, Netherlands

Location

Amsterdam UMC, AMC

Amsterdam, Netherlands

Location

Amsterdam UMC, VUmc

Amsterdam, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

Gelre Ziekenhuis

Apeldoorn, Netherlands

Location

Rijnstate

Arnhem, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Martini Ziekenhuis

Groningen, Netherlands

Location

UMC Groningen

Groningen, Netherlands

Location

Tergooi Ziekenhuis

Hilversum, Netherlands

Location

LUMC

Leiden, Netherlands

Location

St. Antonius

Nieuwegein, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Isala Klinieken

Zwolle, Netherlands

Location

Related Publications (1)

• Jancev M, Snoek FJ, Frederix GWJ, Knottnerus H, Blauw H, Witkop M, Moons KGM, van Bon AC, DeVries JH, Serne EH, van Sloten TT, de Valk HW; DARE study consortium. Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands - study protocol. BMJ Open. 2023 Aug 23;13(8):e074984. doi: 10.1136/bmjopen-2023-074984.

  PMID: 37612114 DERIVED

Related Links

• DARE trial website (Dutch)

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: January 3, 2023
• Study Start: October 3, 2023
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (14)