N/A
Completed N=22
Closed-Loop Glucagon Administration For Hypoglycemia Treatment
Source: ClinicalTrials.gov NCT02181127 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl — 1015; 4375.68 mg/dl/min
Summary
This study will test the hypothesis that a wearable automated bionic pancreas system that automatically delivers glucagon only can prevent or treat hypoglycemia vs. usual care for people with type 1 diabetes > 21 years old.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Glucose Monitor (CGM) Glucose Total Area Over the Curve and Less Than 60 mg/dl |
1015; 4375.68 | — |
| SECONDARY Percentage of Time CGM Glucose Less Than 70 mg/dl Overnight and During Daytime |
3.92; 1.50; 7.94; 10.25 | — |
| SECONDARY Number of Hypoglycemic Episodes With CGMG < 50 mg/dl |
1.73; 5.0 | — |
| SECONDARY Number of Hypoglycemic Episodes With CGMG < 60 mg/dl |
4.14; 8.86 | — |
| SECONDARY Number of Hypoglycemic Episodes With CGMG < 70 mg/dl |
8.95; 12.68 | — |
| SECONDARY Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From All CGMG Measurements: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl, >180 mg/dl, >250 mg/dl |
3.11; 8.73; 33.32; 30.53; 68.91; 61.89 | — |
| SECONDARY Count of Subjects With Mean CGMG < 154mg/dl |
13; 11 | — |
| SECONDARY Mean CGMG During Exercise |
— | — |
| SECONDARY Mean Absolute Relative Deviation (MARD) vs. Subset of BG Measurements Before Meals and at Bedtime |
— | — |
| SECONDARY Mean Absolute Relative Deviation (MARD) Between Capillary Blood Glucose and CGM Glucose Values |
15.20 | — |
| SECONDARY Number of Hypoglycemic Events (< 60 mg/dl) as Determined From BG Measurements |
0.73; 2.59 | — |
| SECONDARY Average BG as Determined From the Measurements Taken Before Meals and Before Bedtime |
— | — |
| SECONDARY Percentage of the BG Values Taken Before Meals and Before Bedimte Less Than 70 mg/dl |
— | — |
| SECONDARY Number of All BG Values Less Than 70 mg/dl |
1.45; 4.23 | — |
| SECONDARY Number of Study Days With Mean BG < 154 mg/dl |
4.4; 4.2 | — |
| SECONDARY Fraction Measurements Within Each of the Following Glucose Ranges as Determined From HemoCue Measurements Taken Before Meals and Before Bed: < 70 mg/dl,70-120 mg/dl,70-180 mg/dl,>180 mg/dl,>250 mg/dl |
— | — |
| SECONDARY Mean BG During Exercise |
— | — |
| SECONDARY • Fraction of BG Values < 70 During Exercise Fraction of BG Values < 70 During Exercise |
— | — |
| SECONDARY Number of Carbohydrate Interventions for Hypoglycemia |
1.25; 1.89 | — |
| SECONDARY Total Number of Grams of Carbohydrate Taken for Hypoglycemia |
23.90; 36.29 | — |
| SECONDARY Insulin Total Daily Dose |
38.7; 37.0 | — |
| SECONDARY • Number of Carbohydrate Interventions for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM) |
— | — |
| SECONDARY Total Number of Grams of Carbohydrate Taken for Hypoglycemia During the Daytime (7:00 AM - 11:00 PM) |
— | — |
| SECONDARY Number of Carbohydrate Interventions for Hypoglycemia Overnight (11:00 PM - 7:00 AM) |
— | — |
| SECONDARY Total Number of Grams of Carbohydrate Taken for Hypoglycemia Overnight (11:00 PM - 7:00 AM) |
— | — |
| SECONDARY Total Glucagon Dosing (mcg/kg/24 Hours) |
6.84; 9.8 | — |
| SECONDARY Episodes of Nausea Per Day on Glucagon vs Placebo |
1.1; 0.4 | — |
Eligibility Criteria
Inclusion Criteria
- Age 21 years or older with type 1 diabetes for at least one year.
- Otherwise healthy (mild chronic disease such as asthma, hypertension, and depression will be allowed if well controlled).
- Self-reported frequency of documented hypoglycemia (BG 3 drinks daily in last 30 days) or substance abuse (any use within the last 6 months of controlled substances without a prescription).
- Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference.
- History of adverse reaction to glucagon (including allergy) besides nausea and vomiting.
- Unwilling or unable to completely avoid acetaminophen during the study period.
- Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.
Data sourced from ClinicalTrials.gov (NCT02181127). 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.