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Continue Glucose Monitoring Before Insulin Pump

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CGM Informed

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring CGM

Eligibility Criteria

2 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Males and Females aged 2-24 years
Clinical diagnosis of Type 1 diabetes mellitus
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.
Basal/bolus insulin regimen using long-acting and rapid-acting insulin
- This will provide a uniform method of insulin therapy.
Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2
Willingness to wear the iPro®2 for 5 days continuously per insertion
Participant agrees to comply with the study protocol requirements
Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights signed by the participant and/or parent guardian

Exclusion Criteria:

Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control
Glucocorticoid use within 2 weeks of study enrollment
Concurrent use of other medications that may affect glycemic control
Prior CGM use in the past 6 months
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.
Non-English or non-Spanish speaking

Sites / Locations

Children's Hospital Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CGM Informed

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)

Secondary Outcome Measures

Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)

Mean Blood Glucose (mg/dL)

Other measures of glycemic variability obtained by iPro2 download

Percentage Time Hyperglycemic

Data obtained by iPro2 download

Total Daily Insulin Dose (Units)

Will be obtained by insulin pump download.

Percentage Basal Insulin (%)

Will be obtained by insulin pump download.

Total Number of Insulin Dose Adjustments

This data will be collected on standardized log sheets.

Total Number of Phone Calls to Clinic Hotline

This data will be collected on standardized log sheets.

Number of Insulin Dose Adjustments Made Per Phone Call

This data will be collected on standardized log sheets.

Episodes of DKA

Total Number of Episodes of Severe Hypoglycemia

Hemoglobin A1c (%)

Difference in HbA1c from baseline to 3 months post-pump start

Number of Participants With Satisfaction of Transition to Pump Therapy

6 question survey addressing patient/parent impressions of the process of transitioning to insulin pump therapy.

Full Information

NCT ID

NCT02813421

First Posted

June 2, 2016

Last Updated

May 3, 2021

Sponsor

Children's Hospital Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT02813421

Brief Title

Continue Glucose Monitoring Before Insulin Pump

Official Title

Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

May 1, 2017 (Actual)

Study Completion Date

May 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Children's Hospital Los Angeles

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

CGM

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CGM Informed

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

CGM Informed

Other Intervention Name(s)

iPro2 Professional Continuous Glucose Monitor

Primary Outcome Measure Information:

Title

Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)

Time Frame

First 6 weeks of insulin pump therapy

Secondary Outcome Measure Information:

Title

Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)

Time Frame

First 5 days of insulin pump therapy

Title

Mean Blood Glucose (mg/dL)

Description

Other measures of glycemic variability obtained by iPro2 download

Time Frame

First 6 weeks of insulin pump therapy

Title

Percentage Time Hyperglycemic

Description

Data obtained by iPro2 download

Time Frame

First 6 weeks of insulin pump therapy

Title

Total Daily Insulin Dose (Units)

Description

Will be obtained by insulin pump download.

Time Frame

First 6 weeks of insulin pump therapy

Title

Percentage Basal Insulin (%)

Description

Will be obtained by insulin pump download.

Time Frame

First 6 weeks of insulin pump therapy

Title

Total Number of Insulin Dose Adjustments

Description

This data will be collected on standardized log sheets.

Time Frame

First 6 weeks of insulin pump therapy

Title

Total Number of Phone Calls to Clinic Hotline

Description

This data will be collected on standardized log sheets.

Time Frame

First 6 weeks of insulin pump therapy

Title

Number of Insulin Dose Adjustments Made Per Phone Call

Description

This data will be collected on standardized log sheets.

Time Frame

First 6 weeks of insulin pump therapy

Title

Episodes of DKA

Time Frame

First 6 weeks of insulin pump therapy

Title

Total Number of Episodes of Severe Hypoglycemia

Time Frame

First 6 weeks of insulin pump therapy

Title

Hemoglobin A1c (%)

Description

Difference in HbA1c from baseline to 3 months post-pump start

Time Frame

Baseline to 3 months post-pump start

Title

Number of Participants With Satisfaction of Transition to Pump Therapy

Description

6 question survey addressing patient/parent impressions of the process of transitioning to insulin pump therapy.

Time Frame

At 6 weeks after start of insulin pump therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males and Females aged 2-24 years Clinical diagnosis of Type 1 diabetes mellitus 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. Basal/bolus insulin regimen using long-acting and rapid-acting insulin - This will provide a uniform method of insulin therapy. Willingness to perform at least 6-8 capillary blood glucose tests per day while wearing the iPro®2 Willingness to wear the iPro®2 for 5 days continuously per insertion Participant agrees to comply with the study protocol requirements Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights signed by the participant and/or parent guardian Exclusion Criteria: Comorbid conditions, including but not limited to cystic fibrosis, oncologic processes, other systemic diseases that may affect overall glycemic control Glucocorticoid use within 2 weeks of study enrollment Concurrent use of other medications that may affect glycemic control Prior CGM use in the past 6 months 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. Non-English or non-Spanish speaking

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jessica A Ferris, MD

Organizational Affiliation

Children's Hospital Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

Children's Hospital Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90027

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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