Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02660242 | The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes | PHASE2 | COMPLETED | 16 | — | — | Jan 1, 2016 | Feb 15, 2017 | Mar 3, 2020 | 2 | United States |
| NCT02411578 | Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia | PHASE2 | COMPLETED | 26 | — | — | Sep 1, 2015 | May 1, 2016 | Mar 3, 2020 | 5 | United States |
Comparison of glycemic response (from blood glucose) during exercise and early recovery between each exercise strategy.
| Arm | Type | Description |
|---|---|---|
| Control | NO_INTERVENTION | No basal insulin adjustment, no carbohydrate intake (until glucose drops \<70 mg/dL). |
| Basal insulin reduction | ACTIVE_COMPARATOR | Basal insulin reduction to 50% five minutes before the start of exercise. |
| Glucose Tabs | ACTIVE_COMPARATOR | Dextrose tabs orally (20 grams) five minutes before the start of exercise and at 30 minutes of exercise (total 40 grams). |
| G-Pen Mini™ (glucagon injection) | EXPERIMENTAL | Glucagon (150 µg) five minutes before the start of exercise (SQ-abdomen). |
| Name | Type | Description |
|---|---|---|
| G-Pen Mini™ (glucagon injection) | DRUG | Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen). |
| Glucose Tabs | OTHER | Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams). |
| Basal Insulin Reduction | OTHER | Basal insulin reduction to 50% 5 minutes before the start of exercise. |
| Glucose Tablets | OTHER | 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon (5 grams of fast-acting carbohydrates (D-Glucose) per tablet) |
Inclusion Criteria: 1. Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin 2. Age 18-\<65 years 3. Duration of T1D ≥ 2 years 4. Random C-peptide \< 0.6 ng/ml 5. Using continuous subcutaneous insulin infusion (CSII; insulin pump) for at least 6 months, with no plans to...