The Effectiveness and Safety of Advanced Hybrid Closed-Loop Insulin Pump MiniMed 780G used in Japan: A Multicenter, Prospective, Observational Study

The Effectiveness and Safety of Advanced Hybrid Closed-Loop Insulin Pump MiniMed 780G used in Japan: A Multicenter, Prospective, Observational Study - ESA-J Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000052747

Enrollment

172

Registered

2023-11-14

Start date

2023-12-12

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: [1] Type 1 diabetes patients (diagnosed based on the diagnostic criteria of the Japanese Diabetes Society) [2] Aged 18 years or more at informed consent [3] Patients starting to use MiniMed 780G [4] Patients who had previously used MiniMed 770G for one year or more

Exclusion criteria

Exclusion criteria: [1] Pregnant patients [2] Patients who had not used Auto Mode of MiniMed 770G [3] Patients with difficulty in follow-up during the study period

Design outcomes

Primary

Measure	Time frame
The percentage of the participants with time in range (TIR) being more than 70% at 52 weeks (Visit 2), compared to that at baseline (Visit 1)	—

Secondary

Measure	Time frame
HbA1c Body mass index (BMI) Auto Mode/ Smart Guard (per week) Sensor Wear (per week) Frequency of low glucose alert Frequency of high glucose alert Average blood glucose levels and standard deviation Frequency of blood glucose measurements (per day) Frequency of calibration (per day) Total daily dose (per day) Bolus amount (per day) Auto correction amount (per day) Auto Basal / Basal amount Set Change Reservoir Change Meals (per day) Carbs entered (per day) Active insulin time Mean sensor glucose level and standard deviation Glucose management indicator (GMI) % Coefficient of variation (%CV) Change in TIR (at 13, 26, 39, 52 weeks from baseline) Change in time below range (TBR) (Level 1, Level 2) (at 13, 26, 39, 52 weeks from baseline) Change in time above range (TAR) (Level 1, Level 2) (at 13, 26, 39, 52 weeks from baseline) Change in time in tight range (TITR)8 (at 13, 26, 39, 52 weeks from baseline) Percentage of the participants with TIR more than 80% (at 13, 26, 39, 52 weeks) Percentage of the participants with TIR more than 70% (at 13, 26, 39 weeks) Percentage of the participants with TIR more than 60% (at 13, 26, 39, 52 weeks) Percentage of the participants with TIR more than 50% (at 13, 26, 39, 52 weeks) Glycemia risk index 9 Frequency of severe hypoglycemia Frequency of diabetic ketoacidosis Occurrence of serious adverse events (SAEs) Occurrence of device-related serious adverse events (SAEs) Occurrence of device-related unanticipated adverse events (adverse events: AEs)	—

Measure

Time frame

HbA1c Body mass index (BMI) Auto Mode/ Smart Guard (per week) Sensor Wear (per week) Frequency of low glucose alert Frequency of high glucose alert Average blood glucose levels and standard deviation Frequency of blood glucose measurements (per day) Frequency of calibration (per day) Total daily dose (per day) Bolus amount (per day) Auto correction amount (per day) Auto Basal / Basal amount Set Change Reservoir Change Meals (per day) Carbs entered (per day) Active insulin time Mean sensor glucose level and standard deviation Glucose management indicator (GMI) % Coefficient of variation (%CV) Change in TIR (at 13, 26, 39, 52 weeks from baseline) Change in time below range (TBR) (Level 1, Level 2) (at 13, 26, 39, 52 weeks from baseline) Change in time above range (TAR) (Level 1, Level 2) (at 13, 26, 39, 52 weeks from baseline) Change in time in tight range (TITR)8 (at 13, 26, 39, 52 weeks from baseline) Percentage of the participants with TIR more than 80% (at 13, 26, 39, 52 weeks) Percentage of the participants with TIR more than 70% (at 13, 26, 39 weeks) Percentage of the participants with TIR more than 60% (at 13, 26, 39, 52 weeks) Percentage of the participants with TIR more than 50% (at 13, 26, 39, 52 weeks) Glycemia risk index 9 Frequency of severe hypoglycemia Frequency of diabetic ketoacidosis Occurrence of serious adverse events (SAEs) Occurrence of device-related serious adverse events (SAEs) Occurrence of device-related unanticipated adverse events (adverse events: AEs)

—

Countries

Japan

Contacts

Public ContactTakashi Murata

National Hospital Organization Kyoto Medical Center Department of Clinical Nutrition

drmurata@nifty.com075-641-9161

Outcome results