Continue Glucose Monitoring Before Insulin Pump

Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: CGM Informed

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM Informed; CGM data was available for use when determining starting insulin pump doses.	Device: CGM Informed; Other Names: iPro2 Professional Continuous Glucose Monitor
No Intervention: Control; CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)	First 6 weeks of insulin pump therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)		First 5 days of insulin pump therapy
Mean Blood Glucose (mg/dL)	Other measures of glycemic variability obtained by iPro2 download	First 6 weeks of insulin pump therapy
Percentage Time Hyperglycemic	Data obtained by iPro2 download	First 6 weeks of insulin pump therapy
Total Daily Insulin Dose (Units)	Will be obtained by insulin pump download.	First 6 weeks of insulin pump therapy
Percentage Basal Insulin (%)	Will be obtained by insulin pump download.	First 6 weeks of insulin pump therapy
Total Number of Insulin Dose Adjustments	This data will be collected on standardized log sheets.	First 6 weeks of insulin pump therapy
Total Number of Phone Calls to Clinic Hotline	This data will be collected on standardized log sheets.	First 6 weeks of insulin pump therapy
Number of Insulin Dose Adjustments Made Per Phone Call	This data will be collected on standardized log sheets.	First 6 weeks of insulin pump therapy
Episodes of DKA		First 6 weeks of insulin pump therapy
Total Number of Episodes of Severe Hypoglycemia		First 6 weeks of insulin pump therapy
Hemoglobin A1c (%)	Difference in HbA1c from baseline to 3 months post-pump start	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.	At 6 weeks after start of insulin pump therapy

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Investigators: Principal Investigator: Jessica A Ferris, MD, Children's Hospital Los Angeles

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: June 2, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Actual): May 25, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: CGM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CHLA-15-00535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO