Trial Outcomes & Findings for Ultrarapid Insulin Administered by a Bihormonal Closed Loop System in Patients With Type 1 Diabetes (NCT NCT05508061)

Results Overview

Time the glucose level is above range (\>10 mmol/l) expressed as a percentage (%)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

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

Results posted on

2026-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	Lyumjev-Humalog (Insulin Lispro) Sequence Administration of Lyumjev for a 30-day study period (dosage and frequency is patient-dependent) Insulin Lispro Cartridge \[Lyumjev\]: Administration of Lyumjev in combination with the AP system	Humalog-Lyumjev (Insulin Lispro) Sequence 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) Insulin Lispro Cartridge: Administration of Humalog in combination with the AP system (standard therapy)
Overall Study STARTED	5	7
Overall Study COMPLETED	5	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Humalog or Lyumjev (Insulin Lispro) n=12 Participants Administration of Humalog or Lyumjev(cross-over design) for a 30-day study period with a 8-day wash-out period between the two study periods (dosage and frequency is patient-dependent) Insulin Lispro Cartridge: Administration of Humalog in combination with the AP system (standard therapy) Insulin Lispro Cartridge \[Lyumjev\]: Administration of Lyumjev in combination with the AP system
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants
Sex: Female, Male Female	7 Participants n=12 Participants
Sex: Female, Male Male	5 Participants n=12 Participants
Region of Enrollment Netherlands	12 Participants n=12 Participants
Diabetes duration N=12	20.5 years n=12 Participants • Because only the Humalog-Lyumjev sequence was included in the analysis
Diabetes duration N=7 (included in analysis)	17.0 years n=7 Participants • Because only the Humalog-Lyumjev sequence was included in the analysis
HbA1c N=12	50.5 mmol/mol n=12 Participants • Because only the Humalog-Lyumjev sequence was included in the analysis
HbA1c N=7 (included in analysis)	51.0 mmol/mol n=7 Participants • Because only the Humalog-Lyumjev sequence was included in the analysis
BMI N=12	26.0 kg/m^2 STANDARD_DEVIATION 4.2 • n=12 Participants • Because only the Humalog-Lyumjev sequence was included in the analysis
BMI N=7 (included in analysis)	25.0 kg/m^2 STANDARD_DEVIATION 4.3 • n=7 Participants • Because only the Humalog-Lyumjev sequence was included in the analysis

PRIMARY outcome

Timeframe: 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

Population: 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.

Time the glucose level is above range (\>10 mmol/l) expressed as a percentage (%)

Outcome measures

Outcome measures
Measure	Lyumjev-Humalog (Insulin Lispro) Sequence (Lyumjev Period) Administration of Lyumjev for a 30-day study period, 8-day wash-out period, and then standard used Humalog for a 30-day study period (dosage and frequency is patient-dependent) Insulin Lispro Cartridge: Administration of Humalog in combination with the AP system (standard therapy) Insulin Lispro Cartridge \[Lyumjev\]: Administration of Lyumjev in combination with the AP system	Lyumjev-Humalog (Insulin Lispro) Sequence (Humalog Period) Administration of standard used Humalog for a 30-day study period, 8-day wash-out period, and then Lyumjev for a 30-day study period (dosage and frequency is patient-dependent) Insulin Lispro Cartridge: Administration of Humalog in combination with the AP system (standard therapy) Insulin Lispro Cartridge \[Lyumjev\]: Administration of Lyumjev in combination with the AP system	Humalog-Lyumjev (Insulin Lispro) Sequence (Humalog Period) n=7 Participants Administration of standard used Humalog for a 30-day study period, 8-day wash-out period, and then Lyumjev for a 30-day study period (dosage and frequency is patient-dependent) Insulin Lispro Cartridge: Administration of Humalog in combination with the AP system (standard therapy) Insulin Lispro Cartridge \[Lyumjev\]: Administration of Lyumjev in combination with the AP system	Humalog-Lyumjev (Insulin Lispro) Sequence (Lyumjev Period) n=7 Participants Administration of standard used Humalog for a 30-day study period, 8-day wash-out period, and then Lyumjev for a 30-day study period (dosage and frequency is patient-dependent) Insulin Lispro Cartridge: Administration of Humalog in combination with the AP system (standard therapy) Insulin Lispro Cartridge \[Lyumjev\]: Administration of Lyumjev in combination with the AP system
Percentage of Time the Glucose Level is Above 10 mmol/l	—	—	17.2 percentage of time spent above range Standard Deviation 4.9	16.2 percentage of time spent above range Standard Deviation 3.6

SECONDARY outcome

Timeframe: 68 days (whole study period)

Population: All adverse events related to insulin for all twelve participants were recorded

Side effects of insulin (each reported side effect of Humalog and Lyumjev)