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Insulin

Early auto-mode for Infant Development (CLIMB Trial)

Q: Is enrollment open to octogenarians for this experiment?

This research necessitates that <a href="https://www.withpower.com/clinical-trials/all">all</a> participants must be aged between 18 and 45 years old. On the other hand, 271 studies were designed for minors while 1,013 trials target older adults.

Q: What criteria must participants meet in order to qualify for this clinical trial?

To be eligible to join this trial, participants must exhibit dietary habits and fall between the ages of 18-45. A total of 20 volunteers are sought after for participation.

Q: Is access to this experiment currently available for participants?

Per the details listed on clinicaltrials.gov, this research has already reached its recruitment threshold and is no longer seeking candidates. Initially posted on July 15th 2020 and last edited September 5th 2022, there are still 1420 other studies actively searching for patients.

N/A

Waitlist Available

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women aged 18 to 45, with at least a two year duration of type 1 diabetes, on intensive insulin therapy (at least 3 daily insulin injections or insulin pump) with a Hba1c during pregnancy < 9.9 % at study entry who are confirmed by ultrasound, to have a viable singleton pregnancy between 12 and 32 weeks gestation and are not planning to conceive another pregnancy in the first 24 weeks postpartum.

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks postpartum

Awards & highlights

CLIMB Trial Summary

This trial will use the MiniMed 670G hybrid closed-loop system, which automatically delivers insulin, to see if it improves blood sugar control, episodes of low blood sugar, burden of diabetes self-care, alters baby's weight and feeding patterns, and partner diabetes distress in women with type 1 diabetes after delivery of their neonate.

Eligible Conditions

Infant Development
Type 1 Diabetes
Feeding Disorders
Pregnancy

CLIMB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

CLIMB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of Auto vs. Manual Mode of MiniMed 670G on Time in Target Range Assessed via CGM

Secondary outcome measures

Assess Acceptability of Auto-mode MiniMed 670G via qualitative interviews.

Assess Feasibility of Auto-mode MiniMed 670G via study recruitment, retention and completion rates.

Effect of Auto vs. Manual Mode of MiniMed 670G on Diabetes Self-Care Assessed via Diabetes Distress Scale 3

+5 more

Other outcome measures

Effect of Auto vs. Manual Mode of MiniMed 670G on Breast Milk Consumption Assessed by Difference in Infant Weight

Effect of Auto vs. Manual Mode of MiniMed 670G on Infant Feeding Practices Assessed via Child Food and Liquid Intake Questionnaire

Effect of Auto vs. Manual Mode of MiniMed 670G on Infant Weight, Assessed by Weight Measurements

+3 more

CLIMB Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early auto-mode enabledExperimental Treatment1 Intervention

Auto mode continuous glucose monitoring enabled 2-10 days post-partum

Group II: Delayed auto mode enabledActive Control1 Intervention

Auto mode continuous glucose monitoring enabled 12 weeks post-partum

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Early auto-mode

2020

N/A

~20

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,134 Total Patients Enrolled

1 Trials studying Infant Development

56 Patients Enrolled for Infant Development

Ward of the 21st CenturyOTHER

2 Previous Clinical Trials

2,077 Total Patients Enrolled

Calgary Health TrustOTHER

2 Previous Clinical Trials

948 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment open to octogenarians for this experiment?

"This research necessitates that all participants must be aged between 18 and 45 years old. On the other hand, 271 studies were designed for minors while 1,013 trials target older adults."

Answered by AI

What criteria must participants meet in order to qualify for this clinical trial?

"To be eligible to join this trial, participants must exhibit dietary habits and fall between the ages of 18-45. A total of 20 volunteers are sought after for participation."

Answered by AI

Is access to this experiment currently available for participants?

"Per the details listed on clinicaltrials.gov, this research has already reached its recruitment threshold and is no longer seeking candidates. Initially posted on July 15th 2020 and last edited September 5th 2022, there are still 1420 other studies actively searching for patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Closed-Loop Insulin in Mothers With Type 1 Diabetes and Baby Feeding Practices

Lois Donovan 2020. "Closed-Loop Insulin in Mothers With Type 1 Diabetes and Baby Feeding Practices". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04420728.