Portable Artificial Pancreas Applied for Youth and Adolescents

NCT05543850 | Completed DMC

• 1 other identifier: NL79829.000.22
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the performance of a bi-hormonal reactive closed-loop system in adolscents with type 1 diabetes mellitus. The percentage of time spent in the target range (3.9-10.0 mmol/L) is the main outcome and will be compared between the bi-hormonal closed-loop system and the current treatment of the patients. Also, safety parameters, pharmacodynamics and patient reported outcomes (expectations, trust and treatment satisfaction scores) are compared. This study is a monocenter, randomized, cross-over trial with 20 subjects. The subjects will be randomized to receive either the open-loop therapy or the closed-loop therapy for the first two-week study period and switch to the alternate treatment with at least two weeks in between.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Time in range

  The proportion of time spent in the range of 3.9-10.0 mmol/L in %

  2 weeks

Secondary Outcomes (22)

• Time in hypoglycemia 1

  2 weeks

• Time in hypoglycemia 2

  2 weeks

• Time in hyperglycemia 1

  2 weeks

• Time in hyperglycemia 2

  2 weeks

• Mean glucose concentration

  2 weeks

Other Outcomes (7)

• Gender

  Baseline

• Weight

  Baseline

• Length

  Baseline

Study Arms (2)

Open loop control

ACTIVE COMPARATOR

In this arm, the patients will use their usual diabetes therapy. Additionally, patients will wear a blinded DexcomG6 for data collection during the open loop period.

Device: Open-loop control

Bi-hormonal closed-loop control

EXPERIMENTAL

In this arm, treatment consists of the bi-hormonal closed-loop system. A short acting insulin analogue (Humalog, 3 ml pre-filled cartridge, Eli Lilly) and glucagon (Glucagen, Novo Nordisk; 3.15 ml cartridge Accu-Chek Spirit, Roche) will be administered according to the closed-loop algorithm. Additionally, patients will wear a blinded DexcomG6 for data collection during the closed loop period.

Device: Bi-hormonal closed-loop control

Interventions

Bi-hormonal closed-loop control DEVICE

During bi-hormonal closed-loop control insulin and glucagon are administered to the developed closed-loop algorithm. Aditionally, patients will wear a blinded Dexcom G6 for data collection during the closed loop period.

Also known as: Artificial Pancreas (AP), bi-hormonal AP system, AP5

Bi-hormonal closed-loop control

Open-loop control DEVICE

During open-loop control the patients will use their usual diabetes therapy. Aditionally, patients will wear a blinded Dexcom G6 for data collection during the open loop period.

Open loop control

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with type 1 diabetes mellitus
• Twelve to eighteen years old;
• Treated with insulin therapy for at least 6 months;
• Willing and able to sign informed consent or to assent to study participation.

You may not qualify if:

• Impaired awareness of hypoglycaemia (score ≥ 4) according to Gold and/or Clarke questionnaire\[6,7\];
• BMI ≥ 35 kg/m2;
• Pregnancy and/or breastfeeding;
• HbA1c \> 97 mmol/mol (11.0%);
• Use of acetaminophen (paracetamol) during the open loop or closed-loop period,as this may influence the sensor glucose measurements;
• Limited ability to see, hear or feel the alarm signals of the closed-loop system;
• Unwillingness to act in response to the alarm signals;
• Living alone during the night during the closed-loop period (the patient may ask someone to stay over temporarily);
• Expected poor internet connectivity regarding 24/7 tele monitoring;
• Any condition that the local investigator feels would interfere with trial participation or evaluation of the results.

Sponsors & Collaborators

• Inreda Diabetic B.V.: lead
• Stichting Robopump: collaborator
• Rijnstate ziekenhuis: collaborator
• Kinder Diabetes Centrum Nijmegen: collaborator

Study Sites (1)

Rijnstate Ziekenhuis

Arnhem, Gelderland, 6815 AD, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

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)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Study Officials

• Arianne Bon, MD, PhD

  Rijnstate ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a monocenter, randomized cross-over trial. The total duration of the study will be three months: two weeks open loop control and 4-6 training days followed by a two-week closed-loop period, or vice versa, with at least 2 weeks in between.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: October 28, 2022
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)