Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
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Purpose
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 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.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes |
Drug: Glucagon Device: University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Pilot Study in Testing State of the Art Remote Glucose Monitoring at Diabetes Camp |
- Duration of nocturnal hypoglycemia [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]minutes of glucose readings < 70 mg/dl
- Duration of Glucose readings <50 mg/dl [ Time Frame: 8 Hours ] [ Designated as safety issue: Yes ]minutes < 50 mg/dl on Dexcom sensor
- Need for repeat treatments of hypoglcyemia [ Time Frame: 8 Hours ] [ Designated as safety issue: No ]After treatment for hypoglycemia,how many additional treatments were required.
| Estimated Enrollment: | 60 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mini-Glucagon and Remote Monitoring
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. |
Drug: Glucagon Device: University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform |
|
Carbohydrates and Remote Monitoring
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. |
Device: University of Virginia (UVA) Diabetes Assistant (DiAs) Android Platform |
|
No Intervention: Carbohydrates and No Remote Monitoring
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
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. |
Drug: Glucagon |
Eligibility| Ages Eligible for Study: | 7 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year
- Age 7-21 years
- Attendee of Camp De Los Ninos or Conrad Chinnock
- Come to camp with a consent already signed after having talked to study staff about the study, or at the onset of the camp meet with study staff and sign the consent before the first night at camp.
- Using multiple daily insulin injections (Lantus) or on an insulin pump (any brand)
Exclusion Criteria:
- Cystic fibrosis
- Medications such as current use of oral steroids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- History of adhesive allergies which would interfere with sensor wear.
Contacts and Locations| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Bruce Buckingham, MD | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01680653 History of Changes |
| Other Study ID Numbers: | 2012PG-T1D001 |
| Study First Received: | August 28, 2012 |
| Last Updated: | September 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Glucagon |
Glucagon-Like Peptide 1 Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses Incretins |
ClinicalTrials.gov processed this record on May 21, 2013