Type 1 Diabetes Mellitus
Conditions
Keywords
CGM
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.
Interventions
DEVICECGM Informed
Sponsors
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Years to 24 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL) | First 6 weeks of insulin pump therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Blood Glucose (mg/dL) | First 6 weeks of insulin pump therapy | Other measures of glycemic variability obtained by iPro2 download |
| Percentage Time Hyperglycemic | First 6 weeks of insulin pump therapy | Data obtained by iPro2 download |
| 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. |
| Total Number of Insulin Dose Adjustments | First 6 weeks of insulin pump therapy | This data will be collected on standardized log sheets. |
| Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL) | First 5 days of insulin pump therapy | — |
| 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. |
| 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 (%) | Baseline to 3 months post-pump start | Difference in HbA1c from baseline to 3 months post-pump start |
| 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 Number of Phone Calls to Clinic Hotline | First 6 weeks of insulin pump therapy | This data will be collected on standardized log sheets. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CGM Informed CGM data was available for use when determining starting insulin pump doses.
CGM Informed | 5 |
| Control CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care. | 6 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Total | Control | CGM Informed |
|---|---|---|---|
| Age, Continuous | 10.6 years STANDARD_DEVIATION 3.59 | 10.0 years STANDARD_DEVIATION 3 | 11.4 years STANDARD_DEVIATION 4.4 |
| Age of Diagnosis (years) | 8.09 years STANDARD_DEVIATION 3.56 | 8.1 years STANDARD_DEVIATION 3.3 | 8 years STANDARD_DEVIATION 4.2 |
| BMI | 1.37 z-score STANDARD_DEVIATION 0.56 | 1.38 z-score STANDARD_DEVIATION 0.6 | 1.36 z-score STANDARD_DEVIATION 0.58 |
| Daily Basal Insulin (%=percentage of total daily insulin dose that is used for basal insulin)) | 37.8 Percentage of total daily insulin STANDARD_DEVIATION 11.7 | 40.2 Percentage of total daily insulin STANDARD_DEVIATION 10.2 | 33.6 Percentage of total daily insulin STANDARD_DEVIATION 10.2 |
| Daily Insulin dose (u/kg/day) | 0.80 units/kg/day STANDARD_DEVIATION 0.42 | 0.72 units/kg/day STANDARD_DEVIATION 0.28 | 0.96 units/kg/day STANDARD_DEVIATION 0.55 |
| Duration of Diabetes (years) | 2.50 years STANDARD_DEVIATION 3.27 | 1.8 years STANDARD_DEVIATION 1 | 3.3 years STANDARD_DEVIATION 4.9 |
| Episodes of DKA | 0 Episodes | 0 Episodes | 0 Episodes |
| Frequency of Blood Glucose Monitoring (times/day) | 6.26 Times/day STANDARD_DEVIATION 1.99 | 6.7 Times/day STANDARD_DEVIATION 1.3 | 5.7 Times/day STANDARD_DEVIATION 2.6 |
| Hemoglobin A1c (%) | 7.55 Percentage STANDARD_DEVIATION 1.25 | 7.5 Percentage STANDARD_DEVIATION 0.94 | 7.6 Percentage STANDARD_DEVIATION 1.7 |
| Mean glucose (mg/dL) | 172 mg/dL STANDARD_DEVIATION 40 | 171 mg/dL STANDARD_DEVIATION 38 | 173 mg/dL STANDARD_DEVIATION 46 |
| Population total number of episodes of significant hypoglycemia | 0 Number of Episodes | 0 Number of Episodes | 0 Number of Episodes |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 6 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 1 Participants |
| Tanner Stage | 3 Tanner Stage (1-5) | 2 Tanner Stage (1-5) | 3 Tanner Stage (1-5) |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
Primary
Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)
Time frame: First 6 weeks of insulin pump therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Informed | Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL) | 81.7 Percentage of time | Standard Deviation 13 |
| Control | Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL) | 68.0 Percentage of time | Standard Deviation 27 |
Secondary
Episodes of DKA
Time frame: First 6 weeks of insulin pump therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CGM Informed | Episodes of DKA | 0 Episodes |
| Control | Episodes of DKA | 0 Episodes |
Secondary
Hemoglobin A1c (%)
Difference in HbA1c from baseline to 3 months post-pump start
Time frame: Baseline to 3 months post-pump start
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Informed | Hemoglobin A1c (%) | -0.27 Percentage of HbA1c | Standard Deviation 0.5 |
| Control | Hemoglobin A1c (%) | 0.025 Percentage of HbA1c | Standard Deviation 0.67 |
Secondary
Mean Blood Glucose (mg/dL)
Other measures of glycemic variability obtained by iPro2 download
Time frame: First 6 weeks of insulin pump therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Informed | Mean Blood Glucose (mg/dL) | 137 mg/dL | Standard Deviation 6.6 |
| Control | Mean Blood Glucose (mg/dL) | 193 mg/dL | Standard Deviation 81 |
Secondary
Number of Insulin Dose Adjustments Made Per Phone Call
This data will be collected on standardized log sheets.
Time frame: First 6 weeks of insulin pump therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Informed | Number of Insulin Dose Adjustments Made Per Phone Call | 2.39 Changes/call | Standard Deviation 0.55 |
| Control | Number of Insulin Dose Adjustments Made Per Phone Call | 1.96 Changes/call | Standard Deviation 1.71 |
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.
Time frame: At 6 weeks after start of insulin pump therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM Informed | Number of Participants With Satisfaction of Transition to Pump Therapy | 3 Participants |
| Control | Number of Participants With Satisfaction of Transition to Pump Therapy | 2 Participants |
Secondary
Percentage Basal Insulin (%)
Will be obtained by insulin pump download.
Time frame: First 6 weeks of insulin pump therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Informed | Percentage Basal Insulin (%) | 34.5 Percentage of time | Standard Deviation 17 |
| Control | Percentage Basal Insulin (%) | 27.5 Percentage of time | Standard Deviation 4.8 |
Secondary
Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)
Time frame: First 5 days of insulin pump therapy
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Informed | Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL) | 71 Percentage of time | Standard Deviation 8.2 |
| Control | Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL) | 57.5 Percentage of time | Standard Deviation 10.4 |
Secondary
Percentage Time Hyperglycemic
Data obtained by iPro2 download
Time frame: First 6 weeks of insulin pump therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Informed | Percentage Time Hyperglycemic | 13.7 Percentage of time | Standard Deviation 9.7 |
| Control | Percentage Time Hyperglycemic | 31.7 Percentage of time | Standard Deviation 26 |
Secondary
Total Daily Insulin Dose (Units)
Will be obtained by insulin pump download.
Time frame: First 6 weeks of insulin pump therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Informed | Total Daily Insulin Dose (Units) | 0.88 Units/kg/day | Standard Deviation 0.67 |
| Control | Total Daily Insulin Dose (Units) | 0.87 Units/kg/day | Standard Deviation 0.53 |
Secondary
Total Number of Episodes of Severe Hypoglycemia
Time frame: First 6 weeks of insulin pump therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CGM Informed | Total Number of Episodes of Severe Hypoglycemia | 0 Number of Events |
| Control | Total Number of Episodes of Severe Hypoglycemia | 0 Number of Events |
Secondary
Total Number of Insulin Dose Adjustments
This data will be collected on standardized log sheets.
Time frame: First 6 weeks of insulin pump therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Informed | Total Number of Insulin Dose Adjustments | 18.7 Adjustments | Standard Deviation 4 |
| Control | Total Number of Insulin Dose Adjustments | 12.7 Adjustments | Standard Deviation 11.2 |
Secondary
Total Number of Phone Calls to Clinic Hotline
This data will be collected on standardized log sheets.
Time frame: First 6 weeks of insulin pump therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CGM Informed | Total Number of Phone Calls to Clinic Hotline | 8.33 Phone calls | Standard Deviation 3.51 |
| Control | Total Number of Phone Calls to Clinic Hotline | 5.67 Phone calls | Standard Deviation 2.12 |