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Completed

NCT Number: NCT04051632

Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)

Observational study of patients at Boston Childrens Hospital with type 1 diabetes (T1D) who elected to treat their diabetes with the Medtronic 670 G hybrid closed loop insulin pump.

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Key information

Conditions

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

Age range

5 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

About this study

Outcome study of 90-100 patients with type 1 diabetes who elected to use the Medtronic 670G.

Major outcome measure was to assess the percent of patients who were able to successfully continue to use the 670G technology over time.

Additional outcome variables included hemoglobin A1c pre and post treatment with the 670G, time in desired glucose range 70-180.

Who can participate

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

Inclusion criteria

  • clinical diagnosis of T1D
  • patient of Boston Childrens Hospital diabetes program
  • deemed to be adequate candidates for hybrid closed loop technology by their diabetes health care team
  • patient received Medtronic 670G training at Boston Childrens Hospital
  • patient received follow up diabetes care at Boston Childrens Hospital for at least 3 months after starting on the 670G

Exclusion criteria

  • patients not trained at Boston Childrens Hospital or self started

Treatment and study plan

Medtronic 670G insulin pump

Device
  • percent of patients who continue to use Medtronic 670G over time
  • impact of 670G on glycemic control: hemoglobin A1c, time in range

Primary outcomes

  1. Successful implementation of hybrid closed loop technology

    Time frame: 0-24 months

    Percent of Type 1 Diabetes patients who were properly trained on the use of the 670G that continue to use Hybrid Closed Loop technology at 0, 6, 12, 18 and 24 months post training.

Secondary outcomes

  1. Impact of hybrid closed loop technology on glycemic control

    Time frame: 0-24 months

    Assess impact of hybrid closed loop technology on glycemic control by comparing hemoglobin A1c measurements 0-6 months prior to treatment versus 0-6, 6-12, 12-18, 18-24 months post treatment

  2. Assess impact of hybrid closed loop technology on glycemic control by analysis of sensor glucose data.

    Time frame: 0-24 months.

    Compare sensor glucose data: 1) percent time in range (70-180 mg/dl), 2)percent time in auto-mode, 3) percent time sensor usage versus hemoglobin A1c data over time.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2019
Registry last updated
Aug 9, 2019

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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