N/A
Completed N=57
Testing State of the Art Remote Glucose Monitoring at Diabetes Camp
Source: ClinicalTrials.gov NCT01680653 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Duration of Nocturnal Hypoglycemia — 12.5; 15 minutes — p=0.106
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Nocturnal Hypoglycemia |
12.5; 15 | 0.106 |
| SECONDARY Duration of Glucose Readings <70 mg/dl |
30; 35 | 0.078 |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01680653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.