Evaluation of Medtronic DUO Extended Set

NCT04823312 | Unknown DMC FDA Device

• 1 other identifier: ADA-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center, non-randomized, prospective single arm study of adult subjects with type 1 diabetes utilizing 670G insulin pump therapy with Continuous Glucose Monitoring (CGM). These subjects will be using 4 DUO Extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Type 1

Outcome Measures

Primary Outcomes (1)

• Number of subjects with Duo Extended set failures due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.

  Unexplained hyperglycemia

  7 days

Secondary Outcomes (1)

• Number of subjects with a rate of infusion set survival of 7 days or greater, excluding those that kinked on insertion or accidentally pulled out.

  7 days

Study Arms (1)

Medtronic Duo Extended Set

EXPERIMENTAL

These subjects will be using 4 Duo Extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set.

Device: Experimental prospective single arm evaluating the Medtronic Duo Extended Set

Interventions

Experimental prospective single arm evaluating the Medtronic Duo Extended Set DEVICE

Subjects will be using 4 Duo extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set.

Also known as: Medtronic DUO Extended Set with 670G Pump Therapy

Medtronic Duo Extended Set

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has type 1 diabetes for more than one year.
• Subject is on the MiniMed 670G insulin pump therapy within1 year prior to screening.
• Subject is currently using Auto Mode at least 75% of the time and willing to utilize Auto Mode and Duo device during the study.
• Subject is willing and able to perform study procedures as per investigator discretion.
• Subject is willing to take one of the following two insulins: Humalog or Novolog

You may not qualify if:

• Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
• Subject is female and has a positive pregnancy screening test.
• Subject is female of childbearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator.
• Subject is female and plans to become pregnant during the study.
• Subject has Glycosylated hemoglobin (HbA1c) \> 8.5 % at time of screening.
• Subject has had a history of 1 or more episodes of severe hypoglycemia.
• Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
• Subject is unable to tolerate tape adhesive in the area of Duo™ Extended set or sensor.
• Subject has any unresolved adverse skin condition, including infection, in the area of Duo™ Extended set or sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
• Subject is currently abusing illicit drugs.
• Subject is currently abusing alcohol.
• Subject has history of adrenal disorder.
• Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening.
• Subject has any condition that the Investigator believes would interfere with study participation.

Sponsors & Collaborators

• Atlanta Diabetes Associates: lead
• Medtronic: collaborator

Study Sites (1)

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bruce W Bode, MD

  Atlanta Diabetes Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melody L Cantrell, PharmD

CONTACT

404-355-4393; mcantrell@atlantadiabetes.com

Betsy Childs, RN

CONTACT

404-355-4393; bchilds@atlantadiabetes.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 30, 2021
• Study Start: March 18, 2021
• Primary Completion: October 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)