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Clinical trial

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

ID
Name
NL79588.091.22
Description
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. 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.
Trial arms
Trial start
2022-10-19
Estimated PCD
2023-03-16
Trial end
2023-03-16
Status
Completed
Treatment
Insulin Lispro Cartridge [Lyumjev]
Administration of Lyumjev in combination with the AP system
Arms:
Lyumjev (insulin lispro)
Other names:
Lyumjev
Insulin Lispro Cartridge
Administration of Humalog in combination with the AP system (standard therapy)
Arms:
Humalog (insulin lispro)
Other names:
Humalog
Size
12
Primary endpoint
Percentage of time the glucose level is above 10 mmol/l for the study participants
68 days
Eligibility criteria
Inclusion Criteria: * 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; * HbA1c \< 97 mmol/mol; * BMI \< 35 kg/m\^2; * No use of acetaminophen, as this may influence the sensor glucose measurements. Exclusion Criteria: * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Allocation by randomization:\n\n* Study period 1 (Humalog or Lyumjev)\n* Wash-out period (Humalog: standard therapy)\n* Study period 2 (other type of insulin than in Study period 1 (Humalog or Lyumjev))', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}
Updated at
2023-04-18

1 organization

1 product

1 indication

Organization
Inreda Diabetic
Product
Insulin Lispro
Indication
Type 1 Diabetes