Continue Glucose Monitoring Before Insulin Pump

Study Overview
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Brief Summary
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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
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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.

Official Title
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Professional Continuous Glucose Monitoring Before Starting Insulin Pump Therapy

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: CGM Informed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CGM