Trial Outcomes & Findings for Testing State of the Art Remote Glucose Monitoring at Diabetes Camp (NCT NCT01680653)

NCT ID: NCT01680653

Last Updated: 2018-03-05

Results Overview

Number of minutes with glucose reading \< 50 mg/dL. Each camper had Remote Monitoring nights and Control nights.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 57 participants
• Primary outcome timeframe: 8 hours
• Results posted on: 2018-03-05

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	57
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing State of the Art Remote Glucose Monitoring at Diabetes Camp

Baseline characteristics by cohort

Measure	All Participants n=57 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.
Age, Continuous	13.9 years STANDARD_DEVIATION 3.8 • n=5 Participants
Age, Customized 7-11 years	12 Participants n=5 Participants
Age, Customized 12-16 years	39 Participants n=5 Participants
Age, Customized 17-21 years	6 Participants n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hours

Number of minutes with glucose reading < 50 mg/dL. Each camper had Remote Monitoring nights and Control nights.

Outcome measures

Measure	Remote Monitoring n=24 Hypoglycemic events 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. Mini-glucagon: Mini dose glucagon given for glucose \<70 mg/dl at a dose of 1unit/year of age Remote monitoring: Provides real-time continuous glucose monitoring	Control n=41 Hypoglycemic events 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
Duration of Nocturnal Hypoglycemia	12.5 minutes Interval 10.0 to 20.0	15 minutes Interval 10.0 to 30.0

SECONDARY outcome

Timeframe: 8 Hours

Number of minutes with glucose reading < 70 mg/dL. Each camper had Remote Monitoring nights and Control nights.

Outcome measures

Measure	Remote Monitoring n=78 Hypoglycemic events 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. Mini-glucagon: Mini dose glucagon given for glucose \<70 mg/dl at a dose of 1unit/year of age Remote monitoring: Provides real-time continuous glucose monitoring	Control n=119 Hypoglycemic events 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
Duration of Glucose Readings <70 mg/dl	30 minutes Interval 20.0 to 45.0	35 minutes Interval 25.0 to 72.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 hours at night

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.

Outcome measures

Measure	Remote Monitoring n=57 Participants 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. Mini-glucagon: Mini dose glucagon given for glucose \<70 mg/dl at a dose of 1unit/year of age Remote monitoring: Provides real-time continuous glucose monitoring	Control n=57 Participants 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
Prolonged Episodes of Hypoglycemic Events Events <70 mg/dL >1 hour	7 events	33 events
Prolonged Episodes of Hypoglycemic Events Events <70 mg/dL >2hr	0 events	12 events
Prolonged Episodes of Hypoglycemic Events Events <50 mg/dL >30 mins	0 events	9 events
Prolonged Episodes of Hypoglycemic Events Events <50 mg/dL >1hr	0 events	6 events

Adverse Events

Remote Monitoring

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Control (no Remote Monitoring)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Remote Monitoring n=57 participants at risk All participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights.	Control (no Remote Monitoring) n=57 participants at risk All participants; during the study, each subject was randomized to either the control or the remote monitoring group, and then alternated on subsequent nights.
Skin and subcutaneous tissue disorders mild erythema from the adhesive	5.3% 3/57 • Number of events 3 • 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	5.3% 3/57 • Number of events 3 • 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

Additional Information

Dr. Bruce Buckingham

Stanford University

Phone: 650-725-6549

Email: bbendo@stanford.edu

Results disclosure agreements

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