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Insulin Pump

Hybrid Closed Loop System for Type 1 Diabetes

N/A
Recruiting
Research Sponsored by Medtronic Diabetes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
US, Canada, Australia and New Zealand: Subjects 2-80 years of age will be allowed to enroll in the post approval study.
Europe: Only subjects ≥7 years of age are allowed to enroll in the post-market study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of the Hybrid Closed Loop system (HCL) in adult and pediatric patients with type 1 diabetes at home.

Who is the study for?
This trial is for people aged 2-80 with type 1 diabetes, regardless of their previous treatment method. Participants must be willing to do daily blood glucose checks, use the study's insulin and meter system, have internet access for data uploads, and wear the system consistently. It excludes those with certain medical conditions or treatments that could interfere with the study.Check my eligibility
What is being tested?
The trial tests a Hybrid Closed Loop (HCL) insulin pump system in adults and children to see if it safely manages blood sugar levels at home. The HCL will be compared against participants' current diabetes therapies over a diverse range of patients.See study design
What are the potential side effects?
Potential side effects may include skin irritation from sensor placement or tape adhesive, low or high blood sugar events due to insulin delivery issues, possible device-related complications like infections at infusion sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 2 and 80 years old and live in the US, Canada, Australia, or New Zealand.
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I am 7 years old or older.
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I have been diagnosed with type 1 diabetes for over three months.
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I am 7 years old or older.
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I manage my diabetes with multiple daily injections or an insulin pump.
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I am willing and able to afford the study's insulin treatments.
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I am willing to use the study's glucose meter.
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I use 8 or more units of insulin daily.
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I am between 2 and 80 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CSII Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8%
CSII Cohort: change of A1C (∆A1C) for subjects with baseline A1c > 8%
MDI Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8%
+3 more
Secondary outcome measures
CSII Cohort: Change in A1C (∆A1C) for subjects with baseline A1c ≤ 8%
CSII Cohort: Change in A1C for all subjects
CSII Cohort: Time in Hypoglycemic Range during Day and Night for all subjects
+18 more

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241
21%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Hybrid Closed Loop ArmExperimental Treatment1 Intervention
The HCL Arm will use the MiniMed System (i.e., using Auto Mode) for 6 months during the study period.
Group II: Control ArmActive Control1 Intervention
The Control Arm will use individual subject's current diabetes therapy: CSII (Continuous Subcutaneous Insulin Infusion), MDI (Multiple Daily Injections) or SAP (Sensor Augmented Pump). Each cohort (CSII, MDI, or SAP) will be used as the control arm to be compared to the experimental arm (HCL).

Find a Location

Who is running the clinical trial?

Medtronic DiabetesLead Sponsor
67 Previous Clinical Trials
9,646 Total Patients Enrolled

Media Library

670G and 770G Insulin Pump (Insulin Pump) Clinical Trial Eligibility Overview. Trial Name: NCT02748018 — N/A
Type 1 Diabetes Research Study Groups: Hybrid Closed Loop Arm, Control Arm
Type 1 Diabetes Clinical Trial 2023: 670G and 770G Insulin Pump Highlights & Side Effects. Trial Name: NCT02748018 — N/A
670G and 770G Insulin Pump (Insulin Pump) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02748018 — N/A
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT02748018 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially join this clinical trial?

"This medical study requires potential participants to suffer from diabetes, an autoimmune disorder, and fall in the age range of two to eighty years old. The total number of enrollees is expected to be around 280 people."

Answered by AI

How many participants have joined this clinical examination thus far?

"Affirmative, the records on clinicaltrials.gov attest that this trial is still enrolling patients. Initially posted on May 25th 2017 and last updated November 15th 2022, it requires 280 participants to be sourced across 10 medical centres."

Answered by AI

What are the main aims of this medical experiment?

"Medtronic Diabetes, the study's sponsor, has identified that SAP Cohort: Time in Hypoglycemic Range for subjects with baseline A1c ≤ 8% will be the primary outcome to assess over a 6 month period. Secondary outcomes include CSII Cohort: Change in A1C for all subjects; SAP Cohort: Time in Target Range 70mg/dL (3.9mmol/L) - 180 mg/dL (10.0mmol/L) during Day and Night for all subjects; and finally, SAP Cohort: Change in A1C from baseline to the end of six months treatment period"

Answered by AI

Is eligibility for the trial restricted to individuals aged 30 and below?

"Patients aged between 2 and 80 years old are welcome to participate in this trial."

Answered by AI

How widely dispersed is the Canadian cohort of this trial's research participants?

"At this time, 10 clinical trial sites are accepting participants. These locations include Idaho Falls, Roswell, and Tampa as well as other nearby cities; it is advised that patients select the most convenient site to reduce travel expenses if they choose to join."

Answered by AI

Are there any vacancies that a patient could fill in this research?

"That is correct. The information hosted on clinicaltrials.gov signals that this medical study, first posted in May of 2017, remains open for recruitment and requires the enrollment of 280 participants from 10 separate locations."

Answered by AI

Who else is applying?

What state do they live in?
Florida
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

As I age my Type 1 diabetes gets harder to control. Need all the help I can get.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home
2017. "Multi-center Trial in Adult and Pediatric Patients With Type 1 Diabetes Using Hybrid Closed Loop System and Control at Home". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02748018.
All > Paid Studies Iowa > Type 1 Diabetes
~35 spots leftby Apr 2025
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