Diabetes, Nocturnal Hypoglycemia
Conditions
Keywords
insulin pump, continuous glucose monitor, activity monitor
Brief summary
Increased daytime activity in children and adolescents with type I diabetes is known to be associated with overnight hypoglycemia. We therefore wish to perform a prospective clinical study to assess the feasibility of using activity monitor data to adjust insulin pump basal rates and see whether we can help prevent overnight hypoglycemia or decrease related interventions following high activity days. We plan to carry this out by enrolling 20 subjects (10 subjects 1 to \<7 years old and 10 subjects 7 to 17 years old) with type 1 diabetes managed on insulin pump therapy and having them wear activity monitors and CGMs for up to 3 months. After an initial two-week period to establish activity baselines, we will recommend nighttime basal insulin rate adjustments based on activity monitor, CGM and insulin pump data.
Detailed description
This study is a pilot trial investigating the feasibility of using activity monitoring data to adjust insulin pump therapy and prevent hypoglycemia. The study will enroll 20 patients with type 1 diabetes mellitus on insulin pump therapy, 10 from each of two age groups: younger children aged 1 year to \<7 years of age, and older children aged 7-17 years of age. Subjects will be provided with continuous glucose monitors (DexCom G4) and activity monitors. Study duration will be up to 3 months. During the course of the study patients will continue to receive routine care by their primary endocrinologist and diabetes nurse educator (DNE). Insulin dose adjustments unrelated to activity monitor data will continue to be at the discretion of the patient's primary diabetes team. Activity level (steps and calories burned) will be uploaded over the web in a secure fashion to our central firewall-protected database on a daily basis while CGM glucose values and insulin pump data will be collected once a week. The initial 2 weeks of a subject's enrollment in the study will be used to establish his or her baseline activity level and no changes to the insulin regimen will be made based on the activity monitor data. During weeks 3 to 12, activity data will be reviewed daily and an alternate basal insulin rate will be recommended on days considered to be increased activity days. We will use an adaptive algorithm to help guide suggested insulin basal rate changes. All recommendations will be reviewed and approved by a physician prior to implementation. The alternate rate will be derived using the subject's usual care pump settings as an initial starting point from which to make incremental changes in the 3 hour interval leading up to the hypoglycemic event. Target will be the overnight nadir obtained with usual care settings. Residual error (CGM-target) will be used to assess the validity of using the 3 hour window prior to the event to effect lower basal.
Interventions
DEVICEDexcom 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.
DEVICEActivity 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.
Sponsors
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes (as clinically diagnosed by outpatient endocrinologist). * Treated with insulin pump therapy for greater than or equal 6 months * HbA1C of \<8.5% in the previous 3 months * Families will need to have access to Wi-Fi and a compatible smartphone in order for the data from the activity monitor and other devices to be transmitted to the research team
Exclusion criteria
• Current oral steroid use or other medication known to affect insulin action at investigator's discretion. \*\*\*Note: currently only enrolling patients followed at Boston Children's Hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of Daytime Activity With Nighttime Nadir Glucose. | 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). |
| Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline in Subjects With Activity Effect. | 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. |
Countries
United States
Participant flow
Recruitment details
Twenty participants aged 1 to 17 years were recruited at Boston Children's Hospital beginning in July of 2015.
Participants by arm
| Arm | Count |
|---|---|
| Dexcom G4 Platinum CGM and 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Dexcom G4 Platinum CGM and Activity Monitor |
|---|---|
| Age, Continuous | 12 Years |
| Body Mass Index | 18.7 kg/m^2 STANDARD_DEVIATION 0.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
| Total Daily Insulin Use | 0.8 units of insulin/kg/day |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline.
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.
Time frame: Up to 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexcom G4 Platinum CGM & Activity Monitor | Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline. | 0.11 Supplemental Carb (SC) admin. per night |
Secondary
Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline in Subjects With Activity Effect.
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.
Time frame: Up to 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexcom G4 Platinum CGM & Activity Monitor | Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline in Subjects With Activity Effect. | 0 Carbohydrate interventions per night |
Secondary
Correlation of Daytime Activity With Nighttime Nadir Glucose.
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).
Time frame: Up to 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexcom G4 Platinum CGM & Activity Monitor | Correlation of Daytime Activity With Nighttime Nadir Glucose. | 0.10 Correlation coefficient |