Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy

NCT04284033 | Withdrawn DMC FDA Device

• 1 other identifier: 52526
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized trial to determine if an extended wear infusion set can be worn for up to 7 days with a hybrid closed-loop system in adult with Type 1 Diabetes

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Number of infusion set failures due to "unexplained hyperglycemia"

  Defined as: 1. Glucose \>250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL 2. Ketones ≥0.6 mg/dL with a glucose reading of \>250 mg/dL (in the absence of illness) 3. Evidence of infection at the infusion site (erythema or induration \>1cm in diameter) 4. Pump occlusion alarm

  14 days for each type of infusion set, with each type of infusion set worn twice

Secondary Outcomes (1)

• Duration of infusion set wear

  14 days for each type of infusion set, with each type of infusion set worn twice

Study Arms (2)

Standard then Extended Infusion Set

EXPERIMENTAL

Participants will start with wearing the standard infusion set for up to 7 days, then switch to the Extended Wear infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks

Device: Extended Wear Infusion Set; Device: Standard Infusion Set

Extended then Standard Infusion Set

EXPERIMENTAL

Participants will start with wearing the Extended Wear infusion set for up to 7 days, then switch to the standard infusion set for up to 7 days, then repeat the cycle for a total of 4 weeks

Device: Extended Wear Infusion Set; Device: Standard Infusion Set

Interventions

Extended Wear Infusion Set DEVICE

For two of the 4 weeks, the Extended Wear insulin infusion set will be used

Extended then Standard Infusion Set; Standard then Extended Infusion Set

Standard Infusion Set DEVICE

For two of the 4 weeks, the standard insulin infusion set will be used

Extended then Standard Infusion Set; Standard then Extended Infusion Set

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of type 1 diabetes for more than one year, using an insulin infusion pump for at least 6 months, and using the 670G pump for at least 3 months
• Age ≥18 years
• Using Novolog or Humalog insulin at time of enrollment
• For females, not currently known to be pregnant
• An understanding of and willingness to follow the protocol and sign the informed consent
• Willing to have photographs taken of their infusion sites
• Willing to download their 670G pump every week to a research Carelink account
• Willing to submit a brief online questionnaire at the time of any infusion set failure
• Able to understand spoken or written English
• Hemoglobin A1c \<8.5% at the time of enrollment
• Willing to perform three or more fingerstick glucose measurements each day
• Willing to sign a consent for release of medical information at the time of enrollment
• Willing to change their infusion pump insulin reservoirs at least every 6 days

You may not qualify if:

• Hypoglycemic seizure or loss of consciousness in the past 6 months
• Severe episode of DKA in the 6 months prior to study enrollment that was unrelated to an infusion set failure
• A known cardiovascular disease
• Active proliferative diabetic retinopathy
• Known tape allergy
• Current treatment for a seizure disorder
• Cystic fibrosis
• Active infection
• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
• Inpatient psychiatric treatment in the past 6 months
• Presence of a known adrenal disorder
• If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the last 2 months prior to enrollment in the study
• Abuse of alcohol
• History of dialysis, renal failure or known eGFR \<60 ml/min/1.73m2
• Has received a blood transfusion or required treatment for anemia in the three months prior to enrollment

Sponsors & Collaborators

• Stanford University: lead
• Medtronic: collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

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 Buckingham, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus, Pediatrics - Endocrinology and Diabetes

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: February 25, 2020
• Study Start: February 14, 2017
• Primary Completion: November 10, 2017
• Study Completion: April 20, 2018
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)