Trial Outcomes & Findings for Adjusting Insulin Delivery to Activity (NCT NCT02299479)

Results Overview

Median and inter-quartile range (IQR) of supplemental carbohydrate (SC) interventions (number of SC given by parent divided by the number of days the SC were given) to prevent hypoglycemia during the study period will be compared to those given during the baseline period for each subject. The median and IQR of all subjects will then be calculated.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Up to 3 months

Results posted on

2020-01-09

Participant Flow

Twenty participants aged 1 to 17 years were recruited at Boston Children's Hospital beginning in July of 2015.

Participant milestones

Participant milestones
Measure	Dexcom G4 Platinum CGM & Activity Monitor Volunteers will wear a Dexcom G4 Platinum CGM device as well as an activity monitor. Data will be uploaded to study investigators on a regular basis, and recommendations will be made to adjust insulin dosing based upon analysis of these data. Dexcom G4 Platinum CGM: Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity. Activity monitor: Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adjusting Insulin Delivery to Activity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexcom G4 Platinum CGM and Activity Monitor n=20 Participants Volunteers will wear a Dexcom G4 Platinum CGM device as well as an activity monitor. Data will be uploaded to study investigators on a regular basis, and recommendations will be made to adjust insulin dosing based upon analysis of these data. Dexcom G4 Platinum CGM: Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity. Activity monitor: Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.
Age, Continuous	12 Years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index	18.7 kg/m^2 STANDARD_DEVIATION 0.6 • n=5 Participants
Total Daily Insulin Use	0.8 units of insulin/kg/day n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Median and inter-quartile range (IQR) of supplemental carbohydrate (SC) interventions (number of SC given by parent divided by the number of days the SC were given) to prevent hypoglycemia during the study period will be compared to those given during the baseline period for each subject. The median and IQR of all subjects will then be calculated.

Outcome measures

Outcome measures
Measure	Dexcom G4 Platinum CGM & Activity Monitor n=18 Participants Volunteers will wear a Dexcom G4 Platinum CGM device as well as an activity monitor. Data will be uploaded to study investigators on a regular basis, and recommendations will be made to adjust insulin dosing based upon analysis of these data. Dexcom G4 Platinum CGM: Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity. Activity monitor: Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.
Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline.	0.11 Supplemental Carb (SC) admin. per night Interval 0.0 to 0.16

SECONDARY outcome

Timeframe: Up to 3 months

Daytime activity will be determined based on steps and calories burned measured by activity monitor. High activity is defined as activity level more than 2 standard deviations above the subject's baseline. Correlations will be performed to assess if there is relationship between daytime activity (8 am to 9 pm) and nighttime nadir blood glucose level (mg/dL).

Outcome measures

Outcome measures
Measure	Dexcom G4 Platinum CGM & Activity Monitor n=18 Participants Volunteers will wear a Dexcom G4 Platinum CGM device as well as an activity monitor. Data will be uploaded to study investigators on a regular basis, and recommendations will be made to adjust insulin dosing based upon analysis of these data. Dexcom G4 Platinum CGM: Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity. Activity monitor: Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.
Correlation of Daytime Activity With Nighttime Nadir Glucose.	0.10 Correlation coefficient Interval 0.01 to 0.27

SECONDARY outcome

Timeframe: Up to 3 months

For subjects with an activity effect (subjects with a correlation between daytime activity and nighttime nadir glucose), median and inter-quartile range (IQR) of supplemental carbohydrate (SC) interventions (number of SC given by parent divided by the number of nights the SC were given) to prevent hypoglycemia during the study period will be compared to those given during the baseline period for each subject. The median and IQR of this subset of subjects will then be calculated.

Outcome measures

Outcome measures
Measure	Dexcom G4 Platinum CGM & Activity Monitor n=10 Participants Volunteers will wear a Dexcom G4 Platinum CGM device as well as an activity monitor. Data will be uploaded to study investigators on a regular basis, and recommendations will be made to adjust insulin dosing based upon analysis of these data. Dexcom G4 Platinum CGM: Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity. Activity monitor: Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.
Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline in Subjects With Activity Effect.	0 Carbohydrate interventions per night Interval 0.0 to 0.16

Adverse Events

Dexcom G4 Platinum CGM & Activity Monitor

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dexcom G4 Platinum CGM & Activity Monitor n=20 participants at risk Volunteers will wear a Dexcom G4 Platinum CGM device as well as an activity monitor. Data will be uploaded to study investigators on a regular basis, and recommendations will be made to adjust insulin dosing based upon analysis of these data. Dexcom G4 Platinum CGM: Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity. Activity monitor: Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.
Endocrine disorders Medication Error (mother incorrectly programmed insulin pump)	5.0% 1/20 • Number of events 1 • Entire course of the protocol, up to 3 months

Additional Information

Garry Steil, PhD

Boston Children's Hospital

Phone: 617 355-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place