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Control IQ for Type 1 Diabetes

Children's National, Washington, United States
Type 1 DiabetesControl IQ - Device
Eligibility
6 - 21
All Sexes
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Study Summary

This trial will test how well a hybrid closed loop system works to control blood sugar in underserved youths with poorly controlled Type 1 diabetes, compared to standard diabetes education and care.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Tandem t:slim X2 insulin pump with Control IQ technology

Study Objectives

1 Primary · 20 Secondary · Reporting Duration: 6 months

6 months
Change in CGM Time in Range (TIR)
Changes in CGM time in hyperglycemia (>180 mg/dL)
Changes in CGM time in hypoglycemia (<70 mg/dL)
Changes in coefficient of variation of mean glucose
Changes in glycemic management indicator (GMI)
Changes in mean CGM glucose
Changes in parental perceptions of the youth's attitudes about diabetes technologies
Changes in parental perceptions of the youth's diabetes distress
Changes in parental perceptions of the youth's diabetes management
Changes in parental perceptions of the youth's diabetes-specific quality of life
Changes in parental perceptions of the youth's perceptions of automated insulin delivery systems
Changes in youth attitudes about diabetes technologies
Changes in youth perceptions diabetes self-management
Changes in youth perceptions of automated insulin delivery systems
Changes in youth perceptions of diabetes distress
Changes in youth perceptions of diabetes-specific quality of life
Glycemic control as measured by hemoglobin A1c
Incidence of diabetic ketoacidosis (DKA)
Incidence of emergency department visits and hospital admissions
Incidence of severe hypoglycemia
Post-Intervention at 6 months
Semi-structured interviews with youth and parents exploring the overall experience and barriers to expanding access to hybrid closed loop technology

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

3
Predictive Low-Glucose Insulin Suspension (PLGS)
3
Extended bolus of insulin then standard bolus of insulin
1
Tandem t:slim X2 insulin pump with Control IQ technology

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Single arm- HCL Therapy
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Control IQ · No Placebo Group · N/A

Single arm- HCL Therapy
Device
Experimental Group · 1 Intervention: Control IQ · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

Who is running the clinical trial?

Brynn MarksLead Sponsor
Tandem Diabetes Care, Inc.Industry Sponsor
35 Previous Clinical Trials
4,393 Total Patients Enrolled
DexCom, Inc.Industry Sponsor
129 Previous Clinical Trials
29,488 Total Patients Enrolled
Children's National Research InstituteLead Sponsor
195 Previous Clinical Trials
206,477 Total Patients Enrolled
Brynn Marks, MD, MSHPHPrincipal InvestigatorChildren's National
Amanda PerkinsPrincipal InvestigatorChildren's National

Eligibility Criteria

Age 6 - 21 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You identify as Black.
You are not allowed to take or start any medication that lowers your blood sugar, except for insulin during the trial.
You are not currently using an insulin pump for your diabetes treatment.
References

Frequently Asked Questions

What are the eligibility requirements for involvement in this trial?

"This investigation is enrolling 30 diabetic individuals aged between 6 to 21. As a requirement, they must have had two A1c values of ≥ 10% in the last two years and one at enrolment, accompanied by an adult that can contact them during medical emergencies. Additionally, participants should possess public healthcare insurance coverage, not be using insulin pump therapy, and demonstrate the capacity to operate related devices as well as adhere to protocol requirements." - Anonymous Online Contributor

Unverified Answer

Is this experimentation available to those aged 20 or older?

"The parameters for this trial dictate that individuals aged 6 to 21 can participate. Subsequently, there are 219 studies catering to minors and 925 designed for geriatric patients available." - Anonymous Online Contributor

Unverified Answer

Are there any available opportunities for individuals to partake in this clinical trial?

"As per the information published on clinicaltrials.gov, this trial is currently in search of participants and it was initially posted on June 1st 2021 with its most recent update being September 1st 2022." - Anonymous Online Contributor

Unverified Answer

How many participants have joined the research project thus far?

"Affirmative, clinicaltrials.gov data reveals that the trial is open for recruitment and was first posted on June 1st 2021. The study has been updated as recently as September 1st 2022 and seeks to enrol 30 participants from a single site." - 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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