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Arm 1 for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Childrens Hospital and Clinics of Minnesota, Saint Paul, MNType 1 DiabetesInsulin Pump with Continuous Glucose Monitoring - Device
Eligibility
7 - 80
All Sexes
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Study Summary

This trial tests the safety and effectiveness of an insulin pump and glucose monitor for adults and kids with type 1 diabetes.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

4 Primary · 4 Secondary · Reporting Duration: 3 months

3 months
Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL)
Primary Safety Endpoint for Age 18-80 - Change in HbA1c
Primary Safety Endpoint for Age 7-17 - Change in HbA1c
Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL)
Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL)
Secondary Effectiveness Endpoint 2 for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL)

Trial Safety

Safety Progress

1 of 3

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1
VCTX211 unit
3
Afrezza
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Side Effects for

NPH With Corticosteroid
21%Hypoglycemia
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT01970241) in the NPH With Corticosteroid ARM group. Side effects include: Hypoglycemia with 21%.

Trial Design

2 Treatment Groups

Arm 1
1 of 2
MiniMed™ 780G system with DS5
1 of 2

Experimental Treatment

250 Total Participants · 2 Treatment Groups

Primary Treatment: Arm 1 · No Placebo Group · N/A

Arm 1
Device
Experimental Group · 1 Intervention: Insulin Pump with Continuous Glucose Monitoring · Intervention Types: Device
MiniMed™ 780G system with DS5
Device
Experimental Group · 1 Intervention: Insulin Pump with Continuous Glucose Monitoring · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Who is running the clinical trial?

Medtronic DiabetesLead Sponsor
67 Previous Clinical Trials
9,768 Total Patients Enrolled

Eligibility Criteria

Age 7 - 80 · All Participants · 13 Total Inclusion Criteria

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References

Frequently Asked Questions

Do octogenarians qualify for participation in this research project?

"According to the trial's guidelines, those between 7 and 80 years old are suitable for enrollment." - Anonymous Online Contributor

Unverified Answer

Are participants currently being enlisted for this experiment?

"Evidently, this clinical trial is not presently enrolling new participants. The experiment was initially posted on March 1st 2023 and had its last update around the 26th of January in the same year. Although no longer accepting applicants, there are 370 other studies that need patients right now." - Anonymous Online Contributor

Unverified Answer

How many sites are facilitating the implementation of this clinical trial?

"This investigation is currently recruiting from 20 different sites, ranging from Palo Alto to Walnut Creek and beyond. Prospective participants should select the nearest location to minimize travel requirements if they decide to join this trial." - Anonymous Online Contributor

Unverified Answer

What conclusions is this research attempting to reach?

"This clinical trial is evaluating the safety of a new medication and will primarily assess HbA1c levels over three months. Additionally, it aims to evaluate the drug's efficacy by gauging the percent of time in hypoglycemia (Age 7-17) or range (TIR 70-180 mg/dL - Age 18-80 & 7-17) with noninferiority and superiority tests." - Anonymous Online Contributor

Unverified Answer

Are there any eligibility criteria for participation in this trial?

"This clinical trial is seeking 250 individuals suffering from type 1 diabetes, aged between seven and eighty. Candidates must meet the following criteria: be within the aforementioned age range at time of screening; have a diagnosis that can be verified by medical records or source documentation made by an accredited professional; not require legal representation to provide consent due to mental handicap; demonstrate literacy as well as comprehension in the language used for pump instructions; provide informed consent before enrolling in the study; execute fingerstick blood glucose measurements when needed; wear system continuously during duration of study period; possess minimum daily insulin requirement (Total Daily Dose) greater than 8 units of" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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