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OpenTrials
Completed

NCT Number: NCT05418699

Real-life Data From Diabetic Patients on Closed-loop Pumps

To evaluate, in real life, the effect of closed-loop devices on the improvement of glycemic control in diabetic patients managed in the endocrinology departments of secondary care hospitals.

Completed

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Boulogne-sur-Mer, Boulogne-sur-Mer, France

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About this study

In recent years, closed-loop insulin delivery have been developed to deliver real-time glucose-responsive insulin to people with type 1 diabetes mellitus (T1DM). Their use has been validated in clinical trials, but international investigative centers participating in clinical trials are not always representative of secondary care centers, and the patients they manage are also different. The eligibility criteria for participants in clinical trials are more stringent and restrictive than those of the usual patient population of diabetes/endocrinology centers. The socio-demographic characteristics of patients in clinical trials, in particular the ratio of males to females, age or ethnicity, do not necessarily reflect those observed in patients actually using the device.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • type I diabetic
  • with a closed-loop insulin pump

Exclusion criteria

  • under legal protection order
  • patient or legal guardian objecting to the use of the data in the research

Treatment and study plan

closed-loop insulin pump

Device

Follow up of patients with real-time closed-loop insulin delivery systems

Primary outcomes

  1. HbA1c Level

    Time frame: At 3 months

    Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%

Secondary outcomes

  1. HbA1c Level

    Time frame: At 6 months

    Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%

  2. HbA1c Level

    Time frame: At 12 months

    Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%

  3. Time in Range

    Time frame: At 3 months

    Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days

  4. Time in Range

    Time frame: At 6 months

    Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days

  5. Time in Range

    Time frame: At 12 months

    Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days

  6. Time Below Range

    Time frame: At 3 months

    Percentage of time with glucose values below 70 mg/dL in the last 14 days

  7. Time Below Range

    Time frame: At 6 months

    Percentage of time with glucose values below 70 mg/dL in the last 14 days

  8. Time Below Range

    Time frame: At 12 months

    Percentage of time with glucose values below 70 mg/dL in the last 14 days

  9. Time Above Range

    Time frame: At 3 months

    Percentage of time with glucose values above 180 mg/dL in the last 14 days

  10. Time Above Range

    Time frame: At 6 months

    Percentage of time with glucose values above 180 mg/dL in the last 14 days

  11. Time Above Range

    Time frame: At 12 months

    Percentage of time with glucose values above 180 mg/dL in the last 14 days

  12. Coefficient of Variation

    Time frame: At 3 months

    Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)

  13. Coefficient of Variation

    Time frame: At 6 months

    Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)

  14. Coefficient of Variation

    Time frame: At 12 months

    Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)

  15. HbA1c Level

    Time frame: at 18 months

    Hemoglobin A1c is an indicator of your long-term glucose levels. Normal range for the hemoglobin A1c level is between 4% and 5.6%

  16. Time in Range

    Time frame: at 18 months

    Percentage of time spent in the target range between 70 and 180 mg/dL in the last 14 days

  17. Time Below Range

    Time frame: at 18 months

    Percentage of time with glucose values below 70 mg/dL in the last 14 days

  18. Time Above Range

    Time frame: at 18 months

    Percentage of time with glucose values above 180 mg/dL in the last 14 days

  19. Coefficient of Variation

    Time frame: at 18 months

    Ratio of the standard deviation divided by the mean glucose and multiplying by 100 (percentage)

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Registry information

Acronym: BLOOM

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Jun 14, 2022
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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