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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Informed | Experimental | CGM data was available for use when determining starting insulin pump doses. |
|
| Control | No Intervention | CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM Informed | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL) | First 6 weeks of insulin pump therapy |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica A Ferris, MD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM Informed | CGM data was available for use when determining starting insulin pump doses. CGM Informed |
| FG001 | Control | CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CGM Informed | CGM data was available for use when determining starting insulin pump doses. CGM Informed |
| BG001 | Control | CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL) | Posted | Mean | Standard Deviation | Percentage of time | First 6 weeks of insulin pump therapy |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CGM Informed | CGM data was available for use when determining starting insulin pump doses. CGM Informed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jessica Ferris | Children's Hospital Los Angeles | 323-361-4606 | jeferris@chla.usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2016 | Feb 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | BMI Z-score refers to standard deviation above the mean. Mean= 50%ile = z-score of 0, Negative value is SD below the mean, Positive value is SD above the mean. | Mean | Standard Deviation | z-score |
|
| Tanner Stage | Tanner stage represents pubertal stage. Tanner stage is a standardized measure to grade puberty on physical exam using a whole unit scale of 1 (pre-pubertal) through 5 (full pubertal). Insulin requires can differ depending on pubertal stage. | Mean | Full Range | Tanner Stage (1-5) |
|
| Hemoglobin A1c (%) | Mean | Standard Deviation | Percentage |
|
| Mean glucose (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| Frequency of Blood Glucose Monitoring (times/day) | Mean | Standard Deviation | Times/day |
|
| Age of Diagnosis (years) | Mean | Standard Deviation | years |
|
| Duration of Diabetes (years) | Mean | Standard Deviation | years |
|
| Daily Insulin dose (u/kg/day) | Mean | Standard Deviation | units/kg/day |
|
| Daily Basal Insulin (%=percentage of total daily insulin dose that is used for basal insulin)) | Percentage of total daily insulin dose that is used for basal insulin | Mean | Standard Deviation | Percentage of total daily insulin |
|
| Episodes of DKA | Number | Episodes |
|
| Population total number of episodes of significant hypoglycemia | Number | Number of Episodes |
|
| Participants |
|
|
| Secondary | Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL) | One control participant was lost to follow up after first 5 days of insulin pump therapy, therefore n=4 for this outcome, and not after. | Posted | Mean | Standard Deviation | Percentage of time | First 5 days of insulin pump therapy |
|
|
|
| Secondary | Mean Blood Glucose (mg/dL) | Other measures of glycemic variability obtained by iPro2 download | Posted | Mean | Standard Deviation | mg/dL | First 6 weeks of insulin pump therapy |
|
|
|
| Secondary | Percentage Time Hyperglycemic | Data obtained by iPro2 download | Posted | Mean | Standard Deviation | Percentage of time | First 6 weeks of insulin pump therapy |
|
|
|
| Secondary | Total Daily Insulin Dose (Units) | Will be obtained by insulin pump download. | Posted | Mean | Standard Deviation | Units/kg/day | First 6 weeks of insulin pump therapy |
|
|
|
| Secondary | Percentage Basal Insulin (%) | Will be obtained by insulin pump download. | Posted | Mean | Standard Deviation | Percentage of time | First 6 weeks of insulin pump therapy |
|
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| Secondary | Total Number of Insulin Dose Adjustments | This data will be collected on standardized log sheets. | Posted | Mean | Standard Deviation | Adjustments | First 6 weeks of insulin pump therapy |
|
|
|
| Secondary | Total Number of Phone Calls to Clinic Hotline | This data will be collected on standardized log sheets. | Posted | Mean | Standard Deviation | Phone calls | First 6 weeks of insulin pump therapy |
|
|
|
| Secondary | Number of Insulin Dose Adjustments Made Per Phone Call | This data will be collected on standardized log sheets. | Posted | Mean | Standard Deviation | Changes/call | First 6 weeks of insulin pump therapy |
|
|
|
| Secondary | Episodes of DKA | Posted | Number | Episodes | First 6 weeks of insulin pump therapy |
|
|
|
| Secondary | Total Number of Episodes of Severe Hypoglycemia | Posted | Number | Number of Events | First 6 weeks of insulin pump therapy |
|
|
|
| Secondary | Hemoglobin A1c (%) | Difference in HbA1c from baseline to 3 months post-pump start | Posted | Mean | Standard Deviation | Percentage of HbA1c | Baseline to 3 months post-pump start |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At 6 weeks after start of insulin pump therapy |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Control | CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care. | 0 | 6 | 0 | 6 | 0 | 6 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |