Continue Glucose Monitoring Before Insulin Pump

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: CGM Informed

• Registration Number: NCT02813421
• Lead Sponsor: Children's Hospital Los Angeles

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-06-02
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Primary Completion: 2017-05-01
• Study Completion: 2017-05-01
• Results First Submitted: 2019-01-25
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Results First Posted: 2021-05-25
• Last Update Posted: 2021-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGM Informed	CGM Informed	CGM data was available for use when determining starting insulin pump doses.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage Time Hyperglycemic	First 6 weeks of insulin pump therapy	Data obtained by iPro2 download
Total Number of Phone Calls to Clinic Hotline	First 6 weeks of insulin pump therapy	This data will be collected on standardized log sheets.
Mean Blood Glucose (mg/dL)	First 6 weeks of insulin pump therapy	Other measures of glycemic variability obtained by iPro2 download
Total Number of Episodes of Severe Hypoglycemia	First 6 weeks of insulin pump therapy
Hemoglobin A1c (%)	Baseline to 3 months post-pump start	Difference in HbA1c from baseline to 3 months post-pump start
Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)	First 5 days of insulin pump therapy
Total Number of Insulin Dose Adjustments	First 6 weeks of insulin pump therapy	This data will be collected on standardized log sheets.
Episodes of DKA	First 6 weeks of insulin pump therapy
Number of Participants With Satisfaction of Transition to Pump Therapy	At 6 weeks after start of insulin pump therapy	6 question survey addressing patient/parent impressions of the process of transitioning to insulin pump therapy.
Total Daily Insulin Dose (Units)	First 6 weeks of insulin pump therapy	Will be obtained by insulin pump download.
Percentage Basal Insulin (%)	First 6 weeks of insulin pump therapy	Will be obtained by insulin pump download.
Number of Insulin Dose Adjustments Made Per Phone Call	First 6 weeks of insulin pump therapy	This data will be collected on standardized log sheets.

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States