Continue Glucose Monitoring Before Insulin Pump

NCT ID: NCT02813421

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-05-01

Brief Summary

The purpose of the study is to learn more about blood glucose control when people with Type 1 Diabetes switch to an insulin pump. The investigators hope to learn whether using a continuous glucose monitor (CGM) helps to create personalized insulin doses that may lead to stable blood glucoses and less frequent insulin pump dose changes during the transition to an insulin pump.

Detailed Description

This is a prospective, randomized controlled study. Participants will be asked to wear a Medtronic iPro2 continuous glucose monitor (CGM) 1-2 weeks prior to starting on insulin pump therapy. Depending on randomization groups, participants will either have CGM data used inform starting insulin pump doses (treatment group), or to standard of care for starting on insulin pump (control group). Participants will wear the CGM again during the first 5 days of pump start and at approximately 6 weeks after pump start, in order to collect blood glucose data. Each time the CGM is worn, blood glucoses must be checked 6-8 times daily, and a written log must be completed. Baseline medical information also will be collected at the start of participation. Participants will also be asked to complete a questionnaire at approximately 6 weeks after pump start. Participation in the study will be complete after a standard of care follow up visit approximately 3 months after pump start.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CGM Informed

CGM data was available for use when determining starting insulin pump doses.

Group Type: EXPERIMENTAL

CGM Informed

Intervention Type: DEVICE

Control

CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CGM Informed

Intervention Type: DEVICE

Other Intervention Names

iPro2 Professional Continuous Glucose Monitor

Eligibility Criteria

Inclusion Criteria

1. Males and Females aged 2-24 years

2. Clinical diagnosis of Type 1 diabetes mellitus

3. Duration of diabetes: At least 6 months

• This will ensure some glycemic stability prior to study, and most children do not start on an insulin pump until about 6 months into their diagnosis.

4. Basal/bolus insulin regimen using long-acting and rapid-acting insulin

• This will provide a uniform method of insulin therapy.

5. Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2

6. Willingness to wear the iPro®2 for 5 days continuously per insertion

7. Participant agrees to comply with the study protocol requirements

8. Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights signed by the participant and/or parent guardian

Exclusion Criteria

1. Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control

2. Glucocorticoid use within 2 weeks of study enrollment

3. Concurrent use of other medications that may affect glycemic control

4. Prior CGM use in the past 6 months

5. The participant has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of iPro®2 placement that has not been resolved at the time of enrollment and would inhibit the participant from wearing the iPro®2.

6. Non-English or non-Spanish speaking

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Jessica Ferris, MD

Clinical Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica A Ferris, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CHLA-15-00535

Identifier Type: -

Identifier Source: org_study_id