Comparison of CSII and MDI in Pediatric Patients With Type 1 Diabetes

Seoul National University

Status: Unknown

Conditions: Type 1 Diabetes

Treatments: Device: DIA:CONN G8 insulin pump; Other: Multiple daily insulin injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05201846

21111431275

Details and patient eligibility

About

Prospective, randomized, open-label, two-sequence crossover study to investigate the effects of continuous subcutaneous insulin injection (CSII, using DIA:CONN G8 insulin pump) in pediatric patients with type 1 diabetes using multiple daily insulin (MDI) injection

Full description

This trial consists of two crossover periods of 5 weeks each (MDI to CSII or CSII to MDI), followed by an extended period of 12 weeks (MDI or CSII). Each intervention period has wash-out period (5 days) excluded from the outcome measurements.

Enrollment: 66 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subject is aged 2-17

2. The subject with one or more of the below at diagnosis

   • serum c-peptide < 0.6 ng/mL
   • positive glutamic acid decarboxylase (GAD) antibody
   • positive Islet cell antibody
   • positive anti-Insulin antibody
   • positive anti-Islet Antigen-2 (IA-2) antibody

3. The subject was diagnosed with type 1 diabetes ≥ 1 year

4. The subject is treated with multiple daily insulin injection

5. The subject must have available continuous glucose monitoring (CGM) data with a percentage of active CGM time ≥ 70% in the past 4 weeks.

Exclusion criteria

1. Subjects who were treated with insulin pump therapy within 12 weeks prior to trial
2. Any systemic treatment with drugs known to interfere with glucose metabolism within 12 weeks prior to trial
3. Subjects with underlying hematologic disorders that can affect the HbA1c levels
4. Subjects with underlying medical disorders that can affect glucose metabolism
5. Subjects with a neuropsychiatric disorder such as depression or eating disorder
6. Subjects with underlying thyroid disorders and abnormal thyroid function

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Continuous subcutaneous insulin infusion

Experimental group

Description:

Continuous subcutaneous insulin infusion using insulin pump (DIA:CONN G8) with continuous glucose monitoring

Treatment:

Device: DIA:CONN G8 insulin pump

Multiple daily insulin injection

Active Comparator group

Description:

Multiple daily insulin injection with continuous glucose monitoring

Treatment:

Other: Multiple daily insulin injection