Type 1 DiabetesFAST 1NCT05508061

Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes

A study testing Insulin Lispro Cartridge [Lyumjev] and Insulin Lispro Cartridge in people with Type 1 Diabetes, run by Inreda Diabetic B.V. at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The main objective is to determine the efficacy of Lyumjev (insulin) in a bi-hormonal reactive closed loop system for automated glucose regulation (artificial pancreas; AP®) in patients with diabetes mellitus type 1. In addition, safety parameters, pharmacodynamics and AP-related parameters will be acquired. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Insulin Lispro Cartridge [Lyumjev] and Insulin Lispro Cartridge
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 3 sitesNetherlands
Study dates: 19 Oct 2022to 16 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosed with diabetes mellitus type 1;
Treated with the Inreda AP system for a minimum of 1 month;
Age between 18 and 75 years;
Willing and able to sign informed consent.
Since subjects are treated with the Inreda AP, the following inclusion criteria will be met:
Treated with sensor augmented pump (SAP) or CSII for a minimum of 6 months;

Show all 9Show fewer

HbA1c < 97 mmol/mol;
BMI < 35 kg/m^2;
No use of acetaminophen, as this may influence the sensor glucose measurements.

Who cannot join

Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire;
Pregnancy and/or breastfeeding;
Use of oral antidiabetic agents;
Insulinoma;
Hypersensitivity reactions to Lyumjev or any of the excipients.

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

Rijnstate Hospital
Arnhem, Gelderland, 6815 AD
Slingeland Hospital
Doetinchem, Gelderland, 7009 BL
Hospital Gelderse Vallei
Ede, Gelderland, 6716 RP

Other trials in Netherlands

About this study

Official title: Fully Automated Glycemic Control With Ultrarapid Insulin in a Bihormonal Closed Loop System in Patients With Type 1 Diabetes

This study is a multicenter, open-label, randomized, cross-over trial in 12 subjects. The subjects will be randomized to receive either Lyumjev or Humalog® for a 30-day study period and will then switch to the alternate insulin treatment after a wash-out period.

Read the detailed description

Background of the study:

Inreda Diabetic B.V. (Goor, The Netherlands) developed a bi-hormonal reactive closed loop system to automate glucose regulation (artificial pancreas; AP) in patients with diabetes mellitus type 1. In the current CE-marked AP, Humalog® (Eli Lilly) is used as rapid-acting insulin. Currently, the ultra rapid-acting insulin Lyumjev (Eli Lilly) is available but has not yet been tested in combination with the AP of Inreda. Both are insulin lispro, but additions to the insulin lispro allow the insulin to act faster with a shorter duration. The hypothesis is that the combination of Lyumjev and the reactive AP system can decrease the time that glucose values are above range which can have a positive effect on glucose regulation.

Objectives of the study:

The main objective is to determine the efficacy of Lyumjev in the Inreda AP system. Secondary objectives are to assess safety parameters, differences in pharmacodynamics and AP-related outcomes comparing Lyumjev to Humalog®.

Study design:

This study is a multicenter, open-label, randomized, cross-over trial which will be performed in a free-living environment.

Study population:

The study population will comprise 12 subjects with diabetes type 1 using the AP system. Inclusion criteria are subjects from 18 to 75 years and treated with the Inreda AP system for at least 1 month.

Intervention:

The intervention includes the administration of Lyumjev by the Inreda AP system. The subject will be randomized to receive either Lyumjev or Humalog® during the first 30 days. After a wash-out period of 8 days using the standard insulin Humalog®, the subject will switch to the alternate treatment, again for a 30-day period. During the study periods, subjects have to keep a Wi-Fi access point with them.

Primary study parameters/outcome of the study:

Main parameter to express efficacy is the time above range (>10.0 mmol/l), which will be compared between Lyumjev and Humalog®.

Secondary study parameters/outcome of the study:

Safety will be expressed as the side effects of Lyumjev. Pharmacodynamics will be expressed in proportions of time spent in eu-/hypo-/hyperglycemia (%), median glucose value (mmol/l) and glycemic variability (% and interquartile range). These parameters will all be compared between Lyumjev and reference Humalog®.

AP-related outcomes will be expressed in daily administered dosage of insulin and glucagon (units), and the percentage of time that the closed loop algorithm is active (%).

Conditions: Type 1 Diabetes
Being tested: Insulin Lispro Cartridge [Lyumjev], Insulin Lispro Cartridge
Keywords: Ultra rapid-acting insulin, Lyumjev, Humalog®, Artificial pancreas (AP®), Bihormonal reactive closed loop system, Automated glucose regulation, Time above range
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin Lispro Cartridge [Lyumjev]Drug
Also called Lyumjev
Administration of Lyumjev in combination with the AP system
Insulin Lispro CartridgeDrug
Also called Humalog
Administration of Humalog in combination with the AP system (standard therapy)

Study groups in NCT05508061
Study group	Role	What they receive
Lyumjev (insulin lispro)	Experimental	Administration of Lyumjev for a 30-day study period (dosage and frequency is patient-dependent) Receives: Drug: Insulin Lispro Cartridge [Lyumjev]
Humalog (insulin lispro)	Active comparator	Administration of standard used Humalog for a 30-day study period and 8-day wash-out period located between the two study periods (dosage and frequency is patient-dependent) Receives: Drug: Insulin Lispro Cartridge

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Time the Glucose Level is Above 10 mmol/l
Time the glucose level is above range (>10 mmol/l) expressed as a percentage (%)
Measured: 25 days for each intervention period (50 days in total); 5-day training period and washout period were excluded from analysis; data were continuously acquired

Secondary outcomes (10)

Side Effects of Insulin
Side effects of insulin (each reported side effect of Humalog and Lyumjev)
Measured: 68 days (whole study period)
Pharmacodynamic Parameters: Euglycemia
Percentage of time the glucose level is between 3.9 and 10 mmol/l (%)
Measured: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
Pharmacodynamic Parameters: Hypoglycemia
Percentage of time the glucose level is below 3.9 mmol/l (%)
Measured: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
Pharmacodynamic Parameters: Mean Glucose Value
Mean of the glucose values (parameter required to determine the coefficient of variation)
Measured: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
Pharmacodynamic Parameters: Standard Deviation of Glucose Value
Standard deviation of the glucose values (parameter required to determine the coefficient of variation)
Measured: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
Pharmacodynamic Parameters: Glycemic Variability (CoV)
Glycemic variability expressed as the coefficient of variation (CoV): standard deviation divided by the mean of the glucose values (%)
Measured: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
Pharmacodynamic Parameters: Glycemic Variability (IQR)
Glycemic variability expressed as the interquartile range (IQR) (mmol/l)
Measured: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
AP-related Parameters: Daily Insulin Usage (Units)
Daily insulin usage (units)
Measured: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
AP-related Parameters: Glucagon Usage
Daily usage of glucagon (mg)
Measured: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
AP-related Parameters: Algorithm Activity
Percentage of time the algorithm is active (%)
Measured: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Oct 202216 Mar 2023

First posted19 Aug 2022
Study start19 Oct 2022
Primary completion16 Mar 2023
Study completion16 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Allocation by randomization: * Study period 1 (Humalog or Lyumjev) * Wash-out period (Humalog: standard therapy) * Study period 2 (other type of insulin than in Study period 1 (Humalog or Lyumjev))
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05508061
Sponsor's protocol ID: NL79588.091.22
Acronym: FAST 1
Status last verified: Jan 2026
First submitted: 15 Aug 2022
Last updated: 17 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Diabete Mellitus, Autoimmune Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
Not yet recruiting
Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes
Type 2 Diabetes

All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fully Automated Glycemic Control With Ultrarapid Insulin in a Bihormonal Closed Loop System in Patients With Type 1 Diabetes
ClinicalTrials.gov ID: NCT05508061
Acronym / sponsor ID: FAST 1 / NL79588.091.22
Conditions: Type 1 Diabetes
Keywords: Ultra rapid-acting insulin, Lyumjev, Humalog®, Artificial pancreas (AP®), Bihormonal reactive closed loop system, Automated glucose regulation, Time above range
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Inreda Diabetic B.V.Industry (pharma, biotech, devices)
Study start: 19 Oct 2022 (actual)
Primary completion: 16 Mar 2023 (actual)
Study completion: 16 Mar 2023 (actual)
First posted: 19 Aug 2022 (actual)
Results: Posted 17 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Background of the study:

Objectives of the study:

Study design:

This study is a multicenter, open-label, randomized, cross-over trial which will be performed in a free-living environment.

Study population:

Intervention:

Primary study parameters/outcome of the study:

Main parameter to express efficacy is the time above range (>10.0 mmol/l), which will be compared between Lyumjev and Humalog®.

Secondary study parameters/outcome of the study:

AP-related outcomes will be expressed in daily administered dosage of insulin and glucagon (units), and the percentage of time that the closed loop algorithm is active (%).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Allocation by randomization: * Study period 1 (Humalog or Lyumjev) * Wash-out period (Humalog: standard therapy) * Study period 2 (other type of insulin than in Study period 1 (Humalog or Lyumjev))

Arm	Type	Receives
Lyumjev (insulin lispro)	Experimental	Drug: Insulin Lispro Cartridge [Lyumjev]Administration of Lyumjev for a 30-day study period (dosage and frequency is patient-dependent)
Humalog (insulin lispro)	Active comparator	Drug: Insulin Lispro CartridgeAdministration of standard used Humalog for a 30-day study period and 8-day wash-out period located between the two study periods (dosage and frequency is patient-dependent)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Diagnosed with diabetes mellitus type 1;
Treated with the Inreda AP system for a minimum of 1 month;
Age between 18 and 75 years;
Willing and able to sign informed consent.
Since subjects are treated with the Inreda AP, the following inclusion criteria will be met:

Key exclusion criteria (5 listed)

Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire;
Pregnancy and/or breastfeeding;
Use of oral antidiabetic agents;
Insulinoma;
Hypersensitivity reactions to Lyumjev or any of the excipients.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Insulin Lispro Cartridge [Lyumjev]Also: LyumjevAdministration of Lyumjev in combination with the AP system	Drug	Lyumjev (insulin lispro)
Insulin Lispro CartridgeAlso: HumalogAdministration of Humalog in combination with the AP system (standard therapy)	Drug	Humalog (insulin lispro)

Primary outcome

Percentage of Time the Glucose Level is Above 10 mmol/l
Time frame: 25 days for each intervention period (50 days in total); 5-day training period and washout period were excluded from analysis; data were continuously acquired
Time the glucose level is above range (>10 mmol/l) expressed as a percentage (%)

10 secondary outcomes

Side Effects of Insulin
Time frame: 68 days (whole study period)
Pharmacodynamic Parameters: Euglycemia
Time frame: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
Pharmacodynamic Parameters: Hypoglycemia
Time frame: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
Pharmacodynamic Parameters: Mean Glucose Value
Time frame: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
Pharmacodynamic Parameters: Standard Deviation of Glucose Value
Time frame: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
Pharmacodynamic Parameters: Glycemic Variability (CoV)
Time frame: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
Pharmacodynamic Parameters: Glycemic Variability (IQR)
Time frame: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
AP-related Parameters: Daily Insulin Usage (Units)
Time frame: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
AP-related Parameters: Glucagon Usage
Time frame: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)
AP-related Parameters: Algorithm Activity
Time frame: 25 days for each intervention period (50 days in total; 5-day training period and washout period excluded from analysis; data were continuously acquired)

Results and safety

Results posted to the registry on 17 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lyumjev-Humalog (Insulin Lispro) Sequence	5	5
Humalog-Lyumjev (Insulin Lispro) Sequence	7	7

Primary outcome: Percentage of Time the Glucose Level is Above 10 mmol/l

Time frame: 25 days for each intervention period (50 days in total); 5-day training period and washout period were excluded from analysis; data were continuously acquired. Mean (Standard Deviation). Unit: percentage of time spent above range

Measure	Lyumjev-Humalog (Insulin Lispro) Sequence (Lyumjev Period) n = 0	Lyumjev-Humalog (Insulin Lispro) Sequence (Humalog Period) n = 0	Humalog-Lyumjev (Insulin Lispro) Sequence (Humalog Period) n = 7	Humalog-Lyumjev (Insulin Lispro) Sequence (Lyumjev Period) n = 7
Value	–	–	17.2 (4.9)	16.2 (3.6)

Population analysed: AP settings for standard treatment (Humalog) were already optimal as a result of long term regular care. However, in the Lyumjev-Humalog sequence, these optimal AP settings were not set again when starting with Humalog. Instead, optimized settings for Lyumjev were used. This procedural error with an unknown influence on glucose regulation rendered a reliable cross-over comparison impossible, which required exclusion of the AP data from these five participants before data analysis.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days for each intervention period; a total of 68 days including 8-day washout period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lyumjev (Insulin Lispro)	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Humalog (Insulin Lispro)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

Limitations and caveats (from the sponsor): AP settings for standard treatment (Humalog) were already optimal as a result of long term regular care. However, in the Lyumjev-Humalog sequence, these optimal AP settings were not set again when starting with Humalog. Instead, optimized settings for Lyumjev were used. This procedural error with an unknown influence on glucose regulation rendered a reliable cross-over comparison impossible, which required the exclusion of AP data from these five participants before data analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Type 1 Diabetes

Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Diabete Mellitus, Autoimmune Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
Not yet recruiting
Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes
Type 2 Diabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

A. van Bon, MD, PhD principal investigator

Rijnstate Hospital

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Insulin Lispro Cartridge [Lyumjev] and Insulin Lispro Cartridge in people with Type 1 Diabetes, run by Inreda Diabetic B.V. at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Time the Glucose Level is Above 10 mmol/l (time frame: 25 days for each intervention period (50 days in total); 5-day training period and washout period were excluded from analysis; data were continuously acquired). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05508061.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026; AzTrials last refreshed its copy on 2 Nov 2026.