Trial Outcomes & Findings for Continue Glucose Monitoring Before Insulin Pump (NCT NCT02813421)

NCT ID: NCT02813421

Last Updated: 2021-05-25

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: First 6 weeks of insulin pump therapy
• Results posted on: 2021-05-25

Participant Flow

Participant milestones

Measure	CGM Informed CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Overall Study STARTED	5	6
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	CGM Informed CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Overall Study Withdrawal by Subject	1	2
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	CGM Informed n=5 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=6 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.	Total n=11 Participants Total of all reporting groups
Age, Continuous	11.4 years STANDARD_DEVIATION 4.4 • n=5 Participants	10.0 years STANDARD_DEVIATION 3.0 • n=6 Participants	10.6 years STANDARD_DEVIATION 3.59 • n=11 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=6 Participants	6 Participants n=11 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=6 Participants	5 Participants n=11 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	1.36 z-score STANDARD_DEVIATION 0.58 • n=5 Participants	1.38 z-score STANDARD_DEVIATION 0.6 • n=6 Participants	1.37 z-score STANDARD_DEVIATION 0.56 • n=11 Participants
Tanner Stage	3 Tanner Stage (1-5) n=5 Participants	2 Tanner Stage (1-5) n=6 Participants	3 Tanner Stage (1-5) n=11 Participants
Hemoglobin A1c (%)	7.6 Percentage STANDARD_DEVIATION 1.7 • n=5 Participants	7.5 Percentage STANDARD_DEVIATION 0.94 • n=6 Participants	7.55 Percentage STANDARD_DEVIATION 1.25 • n=11 Participants
Mean glucose (mg/dL)	173 mg/dL STANDARD_DEVIATION 46 • n=5 Participants	171 mg/dL STANDARD_DEVIATION 38 • n=6 Participants	172 mg/dL STANDARD_DEVIATION 40 • n=11 Participants
Frequency of Blood Glucose Monitoring (times/day)	5.7 Times/day STANDARD_DEVIATION 2.6 • n=5 Participants	6.7 Times/day STANDARD_DEVIATION 1.3 • n=6 Participants	6.26 Times/day STANDARD_DEVIATION 1.99 • n=11 Participants
Age of Diagnosis (years)	8 years STANDARD_DEVIATION 4.2 • n=5 Participants	8.1 years STANDARD_DEVIATION 3.3 • n=6 Participants	8.09 years STANDARD_DEVIATION 3.56 • n=11 Participants
Duration of Diabetes (years)	3.3 years STANDARD_DEVIATION 4.9 • n=5 Participants	1.8 years STANDARD_DEVIATION 1.0 • n=6 Participants	2.50 years STANDARD_DEVIATION 3.27 • n=11 Participants
Daily Insulin dose (u/kg/day)	0.96 units/kg/day STANDARD_DEVIATION 0.55 • n=5 Participants	0.72 units/kg/day STANDARD_DEVIATION 0.28 • n=6 Participants	0.80 units/kg/day STANDARD_DEVIATION 0.42 • n=11 Participants
Daily Basal Insulin (%=percentage of total daily insulin dose that is used for basal insulin))	33.6 Percentage of total daily insulin STANDARD_DEVIATION 10.2 • n=5 Participants	40.2 Percentage of total daily insulin STANDARD_DEVIATION 10.2 • n=6 Participants	37.8 Percentage of total daily insulin STANDARD_DEVIATION 11.7 • n=11 Participants
Episodes of DKA	0 Episodes n=5 Participants	0 Episodes n=6 Participants	0 Episodes n=11 Participants
Population total number of episodes of significant hypoglycemia	0 Number of Episodes n=5 Participants	0 Number of Episodes n=6 Participants	0 Number of Episodes n=11 Participants

PRIMARY outcome

Timeframe: First 6 weeks of insulin pump therapy

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=3 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Percentage Time Within Target Blood Glucose (Range: 70-180 mg/dL)	81.7 Percentage of time Standard Deviation 13	68.0 Percentage of time Standard Deviation 27

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=4 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Percentage of Time Within Target Blood Glucose (Range: 70-180 mg/dL)	71 Percentage of time Standard Deviation 8.2	57.5 Percentage of time Standard Deviation 10.4

SECONDARY outcome

Timeframe: First 6 weeks of insulin pump therapy

Other measures of glycemic variability obtained by iPro2 download

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=3 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Mean Blood Glucose (mg/dL)	137 mg/dL Standard Deviation 6.6	193 mg/dL Standard Deviation 81

SECONDARY outcome

Timeframe: First 6 weeks of insulin pump therapy

Data obtained by iPro2 download

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=3 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Percentage Time Hyperglycemic	13.7 Percentage of time Standard Deviation 9.7	31.7 Percentage of time Standard Deviation 26

SECONDARY outcome

Timeframe: First 6 weeks of insulin pump therapy

Will be obtained by insulin pump download.

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=3 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Total Daily Insulin Dose (Units)	0.88 Units/kg/day Standard Deviation 0.67	0.87 Units/kg/day Standard Deviation 0.53

SECONDARY outcome

Timeframe: First 6 weeks of insulin pump therapy

Will be obtained by insulin pump download.

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=3 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Percentage Basal Insulin (%)	34.5 Percentage of time Standard Deviation 17	27.5 Percentage of time Standard Deviation 4.8

SECONDARY outcome

Timeframe: First 6 weeks of insulin pump therapy

This data will be collected on standardized log sheets.

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=3 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Total Number of Insulin Dose Adjustments	18.7 Adjustments Standard Deviation 4.0	12.7 Adjustments Standard Deviation 11.2

SECONDARY outcome

Timeframe: First 6 weeks of insulin pump therapy

This data will be collected on standardized log sheets.

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=3 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Total Number of Phone Calls to Clinic Hotline	8.33 Phone calls Standard Deviation 3.51	5.67 Phone calls Standard Deviation 2.12

SECONDARY outcome

Timeframe: First 6 weeks of insulin pump therapy

This data will be collected on standardized log sheets.

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=3 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Number of Insulin Dose Adjustments Made Per Phone Call	2.39 Changes/call Standard Deviation 0.55	1.96 Changes/call Standard Deviation 1.71

SECONDARY outcome

Timeframe: First 6 weeks of insulin pump therapy

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=3 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Episodes of DKA	0 Episodes	0 Episodes

SECONDARY outcome

Timeframe: First 6 weeks of insulin pump therapy

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=3 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Total Number of Episodes of Severe Hypoglycemia	0 Number of Events	0 Number of Events

SECONDARY outcome

Timeframe: Baseline to 3 months post-pump start

Difference in HbA1c from baseline to 3 months post-pump start

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=3 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Hemoglobin A1c (%)	-0.27 Percentage of HbA1c Standard Deviation 0.5	0.025 Percentage of HbA1c Standard Deviation 0.67

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	CGM Informed n=3 Participants CGM data was available for use when determining starting insulin pump doses. CGM Informed	Control n=2 Participants CGM data will remain secure and not used. Starting insulin pump doses will be made by standard of care.
Number of Participants With Satisfaction of Transition to Pump Therapy	3 Participants	2 Participants

Adverse Events

CGM Informed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jessica Ferris

Children's Hospital Los Angeles

Phone: 323-361-4606

Email: jeferris@chla.usc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place