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

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ClinicalTrials.gov Identifier: NCT04051632
Recruitment Status : Completed
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
Gregory Goodwin, Boston Children’s Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Biomedical Technology Type 1 Diabetes Device: Medtronic 670G insulin pump

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)
Actual Study Start Date : June 13, 2018
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort Intervention/treatment
Type 1 Diabetes patients treated with the Medtronic 670G
Type 1 Diabetes patients treated with the Medtronic 670G at Boston Childrens Hospital
Device: Medtronic 670G insulin pump
  • percent of patients who continue to use Medtronic 670G over time
  • impact of 670G on glycemic control: hemoglobin A1c, time in range




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Single institution clinic population.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051632


Locations
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United States, Massachusetts
Boston Childrens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Gregory Goodwin, MD Boston Children’s Hospital

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Responsible Party: Gregory Goodwin, Senior Associate Physician in Medicine, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT04051632     History of Changes
Other Study ID Numbers: IRB-P00028472
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Gregory Goodwin, Boston Children’s Hospital:
Medtronic 670G

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs