Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRB 27428 | Other Identifier | Stanford IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Virginia | OTHER |
| DexCom, Inc. | INDUSTRY |
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The incidence of low blood sugar and hypoglycemic seizures at diabetes camp has been reduced thanks to overnight blood glucose level testing. The timing of the overnight blood test is often arbitrary and it is unclear when the highest frequency of nocturnal hypoglycemic events at camp are occurring. It is also unclear what the most appropriate treatment for nocturnal hypoglycemia is: simple carbohydrates, or mini-glucagon.
In this study, we will use Continuous Glucose Monitors (CGMs) that will send subject data securely to a remote computer located in the medical cottage at camp throughout the night. Study staff will monitor the computer and will intervene on low blood sugar as it occurs in real time. On half of the nights, campers will receive mini-glucagon for low blood sugar, and on the rest, they will receive standard carbohydrate treatment.
The study will include approximately 20 subjects with Type 1 Diabetes per camp session. 10 will be linked to remote monitoring with the Diabetes Assistant Computational/Communication platform (DIAs), and 10 will wear the Dexcom CGM with the same threshold alarm setting as those wearing the DiAs (70 mg/dl), but without remote monitoring.
Study participants will be between the ages of 7-21 with type 1 diabetes. This would allow for a counselor in training or a young counselor with a history of recent nocturnal hypoglycemia to be included. It is these late adolescents and young adults who often have the most severe hypoglycemic events during a camp session. We will preferentially recruit campers into the study who: 1) have a history of nocturnal hypoglycemia requiring treatment within the last 2 months, 2) have hypoglycemia unawareness confirmed with the Clark screening test, 3) have an A1c of <8% while requiring >0.7 units/kg/day of insulin and diabetes duration of > 1year.
At the beginning of camp, a Dexcom G4 sensor will be inserted into each participating subject and after the initial calibration, they will be calibrated with blood glucose levels in the morning and before bed each day as well as when the Dexcom sensor requests a calibration. All insulin doses and treatment decisions at camp will be based on capillary blood glucose levels and they will not be based on sensor readings. Each night, 10 of the 20 campers will be randomly assigned to remote monitoring. The randomization schedule will be computer generated prior to camp. A hypoglycemia threshold will be set for 70 mg/dl. The Dexcom communicating with the DiAs will not sound a local alarm, but an alarm will be generated at the remote monitoring. Medical personnel on call at the remote monitoring station will come to the camper's cabin and confirmatory capillary blood glucose (CBG) glucose will be obtained. If the camper is <70 hypoglycemia, treatment will be given (we will not use predictive alarms or use the rate of change to determine treatment). Treatment will be randomized to mini-glucagon or standard oral treatment if campers are <70 mg/dl in a 1:1 ratio. All subjects less than 70 mg/dl will then be retested in 15 minutes with a CBG to confirm recovery from hypoglycemia.
If a sensor should fail or be dislodged during camp, it will be replaced. If a sensor needs to be replaced more than 2 times, a subject may be dropped and a different subject enrolled.
There will be a designed medical staff person who will be monitoring subjects remotely each night. A second staff person will be available to go to subjects cabins to provide treatment for hypoglycemia. If a second event should occur at the same time, a third staff person will be "on call" to attend the second camper.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mini-Glucagon and Remote Monitoring | Experimental | Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below. Administer mini-glucagon as treatment for nocturnal hypoglycemia. Administer 0.01 cc per number of years in age via insulin syringe, subcutaneously. This amounts to 1 unit per age, for example: an 8 year old gets 8 "units" glucagon. |
|
| Carbohydrates and Remote Monitoring | Other | Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below. Administration of carbohydrate per camp protocol to treat nocturnal hypoglycemia. Expected treatment is 15-45g. |
|
| Carbohydrates No Remote Monitoring | Other | Subjects wear a continuous glucose monitor for their own use, but they are not remotely monitored. If hypoglycemia occurs and is acknowledged through standard camp protocol it will be treated with standard camp protocol administration of carbohydrates. Expected treatment is 15g-45g. |
|
| Mini-Glucagon and No Remote Monitoring |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mini-glucagon | Drug | Mini dose glucagon given for glucose <70 mg/dl at a dose of 1unit/year of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Nocturnal Hypoglycemia | Number of minutes with glucose reading < 50 mg/dL. Each camper had Remote Monitoring nights and Control nights. | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Glucose Readings <70 mg/dl | Number of minutes with glucose reading < 70 mg/dL. Each camper had Remote Monitoring nights and Control nights. | 8 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged Episodes of Hypoglycemic Events | Prolonged hypoglycemia is defined as glucose readings of either <70 mg/dL for greater than one hour on and off the device, <70 mg/dL for greater than 2 hours on and off the device, <50 mg/dL that lasted longer than 30 minutes on and off the device and readings of <50 mg/dL for longer than an hour, again for both the control and the subjects that were remotely monitored with the device. Each camper had Remote Monitoring nights and Control nights. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bruce Buckingham, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24168317 | Result | DeSalvo DJ, Keith-Hynes P, Peyser T, Place J, Caswell K, Wilson DM, Harris B, Clinton P, Kovatchev B, Buckingham BA. Remote glucose monitoring in camp setting reduces the risk of prolonged nocturnal hypoglycemia. Diabetes Technol Ther. 2014 Jan;16(1):1-7. doi: 10.1089/dia.2013.0139. Epub 2013 Oct 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Potential subjects were recruited from clinic; if more than 20 subjects were interested in participating in a given session, we preferentially enrolled those with a history of nocturnal awareness confirmed within the previous 2 months, (hypoglycemia unawareness confirmed with the Clarke screening test), or A1c <8% needing >0.7 units/kg day insulin.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | The subjects participated in three camps; each camp had approximately 20 subjects. There were two locations, one hosting two sessions. Each camp was approximately 5-6 days in length. Campers wore the device on alternating days, and hypoglycemia was treated with either mini glucagon or carbohydrates. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | The subjects were enrolled at three camps for diabetes; from each camp approximately 20 subjects were enrolled. There were two locations, one hosting two sessions. Each camp was approximately 5-6 days in length. Campers wore a continuous glucose sensor every day they were in the study. On alternate nights they had remote monitoring, this defined the primary treatment arms: remote monitoring or no remote monitoring. On alternating days of remote monitoring hypoglycemia was treated with either mini glucagon or carbohydrates, this was a secondary randomization. |
| 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 | Duration of Nocturnal Hypoglycemia | Number of minutes with glucose reading < 50 mg/dL. Each camper had Remote Monitoring nights and Control nights. | Posted | Median | Inter-Quartile Range | minutes | 8 hours | Hypoglycemic events | Hypoglycemic events |
|
AE data was collected during the camp study periods (from 5-6 days for each of the 3 camps).
Serious hypoglycemic events are recorded as AEs if the event required assistance due to altered consciousness and required another person to actively administer treatment. Hyperglycemic events are AEs if the event involved DKA, polyuria, polydipsia, nausea, vomiting, serum ketones, blood pH <7.3, venous pH <7.24, or serum bicarbonate <15
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remote Monitoring | All participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild erythema from the adhesive | Skin and subcutaneous tissue disorders | Systematic Assessment | 5% of the campers had mild erythema from the adhesive, and there was no significant edema or induction at the sensor insertion sites. |
Limitations revolved around sensor failure. There was one subject removed because of improper use of the device (turning it off at improper times and failing to calibrate as instructed).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bruce Buckingham | Stanford University | 650-725-6549 | bbendo@stanford.edu |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005934 | Glucagon |
| D002241 | Carbohydrates |
| ID | Term |
|---|---|
| D052336 | Proglucagon |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
Subjects wear a continuous glucose monitor for their own use, but they are not remotely monitored. If hypoglycemia occurs and is acknowledged through standard camp protocol it will be treated with mini-glucagon. Administer mini-glucagon as treatment for nocturnal hypoglycemia. Administer 0.01 cc per number of years in age via insulin syringe, subcutaneously. This amounts to 1 unit per age, for example: an 8 year old gets 8 "units" glucagon. |
|
|
| Remote monitoring | Device | Provides real-time continuous glucose monitoring |
|
| Carbohydrates | Dietary Supplement | 16 grams of carbohydrate |
|
| 8 hours at night |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Subjects glucose data are remotely monitored at night using the University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform. Study staff intervenes with a fingerstick blood glucose measurement when sensor value falls below 70mg/dL. If fingerstick value is less than 70 mg/dL, hypoglycemic treatment is administered as below. Administration of carbohydrate per camp protocol to treat nocturnal hypoglycemia. Expected treatment is 15-45g. Remote monitoring: Provides real-time continuous glucose monitoring Carbohydrates and remote monitoring: 16 grams of carbohydrate with remote monitoring |
|
|
|
| Secondary | Duration of Glucose Readings <70 mg/dl | Number of minutes with glucose reading < 70 mg/dL. Each camper had Remote Monitoring nights and Control nights. | Posted | Median | Inter-Quartile Range | minutes | 8 Hours | Hypoglycemic events | Hypoglycemic events |
|
|
|
|
| Other Pre-specified | Prolonged Episodes of Hypoglycemic Events | Prolonged hypoglycemia is defined as glucose readings of either <70 mg/dL for greater than one hour on and off the device, <70 mg/dL for greater than 2 hours on and off the device, <50 mg/dL that lasted longer than 30 minutes on and off the device and readings of <50 mg/dL for longer than an hour, again for both the control and the subjects that were remotely monitored with the device. Each camper had Remote Monitoring nights and Control nights. | Posted | Number | events | 8 hours at night |
|
|
|
|
| 0 |
| 57 |
| 3 |
| 57 |
| EG001 | Control (no Remote Monitoring) | All participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights. | 0 | 57 | 3 | 57 |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Events <50 mg/dL >30 mins |
|
| Events <50 mg/dL >1hr |
|
| Fisher's exact test |
| 0.010 |
| 2-Sided |
| Superiority or Other |
| This is the p value for the number of events that were <50 mg/dL for > 30 minutes | Fisher's exact test | 0.021 | 2-Sided | Superiority or Other |
| This is the P value for the number of events <50 mg/dL that were >1 hr | Fisher's exact | 0.077 | 2-Sided | Superiority or Other |