Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format,

NCT03858062 | Completed

• 1 other identifier: NL55693.018.15
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

In previous studies, the investigators tested the feasibility of a bi-hormonal reactive closed loop system without mealtime announcement. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center (APPEL 1 and 2) as well as at the home of the patients (APPEL 3 and 4). After the APPEL 4 study some improvements have been made to the miniaturized prototype to allow patients to operate the system independently and additional risk control measures were included. The main objective of this study is to assess the efficacy of this improved closed loop system.

Conditions

Diabetes Mellitus, Type 1

Keywords

Artificial pancreas; Glucose control

Outcome Measures

Primary Outcomes (1)

• Time in target

  Proportion of time spent in the target range (3.9-10 mmol/l)

  Week 1-2

Secondary Outcomes (22)

• Time in hypoglycemia 1

  Week 1-2 / Week 1 / Week 2

• Time in hypoglycemia 2

  Week 1-2 / Week 1 / Week 2

• Time in hyperglycemia 1

  Week 1-2 / Week 1 / Week 2

• Time in hyperglycemia 2

  Week 1-2 / Week 1 / Week 2

• Hypoglycemic events

  Week 1-2 / Week 1 / Week 2

Other Outcomes (11)

• Demographic variables

  Baseline

• Weight

  Baseline

• Length

  Baseline

Study Arms (2)

Open loop

ACTIVE COMPARATOR

14 days patient-managed Insulin pump therapy (with or without glucose sensor) with blinded continuous glucose monitoring

Device: Insulin pump therapy (with or without glucose sensor)

Closed loop

EXPERIMENTAL

4-6 training + 14 days automated blood glucose control with the Artificial pancreas (Inreda Diabetic)

Device: Artificial pancreas (Inreda Diabetic)

Interventions

Insulin pump therapy (with or without glucose sensor) DEVICE

Patients' own insulin pump with fast-acting insulin analog and optionally with own glucose sensor

Also known as: Continuous subcutaneous insulin infusion (CSII), Sensor augmented pump therapy (SAP)

Open loop

Artificial pancreas (Inreda Diabetic) DEVICE

Bi-hormonal reactive closed loop system without mealtime announcement

Also known as: Closed loop therapy

Closed loop

Eligibility Criteria

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

You may qualify if:

• Diagnosed with diabetes mellitus type 1;
• Treated with SAP or CSII for a minimum of 6 months;
• Willing and able to sign informed consent.

You may not qualify if:

• Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire;
• BMI \> 35 kg/m2;
• HbA1c \> 97 mmol/mol (=11.0 %);
• Use of heparin, coumarin derivatives or oral corticosteroids;
• Use of acetaminophen during the open loop or closed loop period, as this may influence the sensor glucose measurements;
• Limited ability to see, and to hear or feel alarm signals of the closed loop system;
• Skin condition prohibiting needle insertion;
• Pregnancy and/or breastfeeding;
• Living alone during the night during the closed loop period (the patient may ask someone to stay over temporarily);
• Expected poor connectivity with internet regarding 24/7 tele monitoring;
• Any condition that the local investigator feels would have interfere with trial participation or the evaluation of the results

Sponsors & Collaborators

• J.H. DeVries: lead
• Rijnstate Hospital: collaborator
• Inreda Diabetic B.V.: collaborator

Study Sites (2)

Rijnstate Hospital

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (3)

• van Bon AC, Luijf YM, Koebrugge R, Koops R, Hoekstra JB, DeVries JH. Feasibility of a portable bihormonal closed-loop system to control glucose excursions at home under free-living conditions for 48 hours. Diabetes Technol Ther. 2014 Mar;16(3):131-6. doi: 10.1089/dia.2013.0166. Epub 2013 Nov 13.

  PMID: 24224750 BACKGROUND

• Blauw H, van Bon AC, Koops R, DeVries JH; , on behalf of the PCDIAB consortium. Performance and safety of an integrated bihormonal artificial pancreas for fully automated glucose control at home. Diabetes Obes Metab. 2016 Jul;18(7):671-7. doi: 10.1111/dom.12663. Epub 2016 Apr 25.

  PMID: 26996542 BACKGROUND

• Blauw H, Onvlee AJ, Klaassen M, van Bon AC, DeVries JH. Fully Closed Loop Glucose Control With a Bihormonal Artificial Pancreas in Adults With Type 1 Diabetes: An Outpatient, Randomized, Crossover Trial. Diabetes Care. 2021 Mar;44(3):836-838. doi: 10.2337/dc20-2106. Epub 2021 Jan 4.

  PMID: 33397767 DERIVED

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

• J.H. DeVries, MD PhD

  Academisch Medisch Centrum, Universiteit van Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Endocrinologist

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 28, 2019
• Study Start: March 10, 2019
• Primary Completion: September 12, 2019
• Study Completion: September 12, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)