Glycemic Response During Exercise and Early Recovery
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Control | 86 | 30 |
| Basal Insulin Reduction | 85 | 25 |
| Glucose Tabs | 174 | 59 |
| G-Pen Mini™ (Glucagon Injection) | 161 | 39 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes
NCT02660242Jan 2016 to 15 Feb 2017
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This project focuses on development of new strategy for the prevention of exercise-associated hypoglycemia using mini-dose glucagon.
No intervention
Control
No basal insulin adjustment, no carbohydrate intake (until glucose drops \<70 mg/dL).
Active comparator
Basal insulin reduction
Basal insulin reduction to 50% five minutes before the start of exercise.
Active comparator
Glucose Tabs
Dextrose tabs orally (20 grams) five minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Experimental
G-Pen Mini™ (glucagon injection)
Glucagon (150 µg) five minutes before the start of exercise (SQ-abdomen).
Outcomes the sponsor listed as primary.
Glycemic Response During Exercise and Early Recovery
Time frame · 0 to 75 minutes following exercise initiation (0, 5, 10, 15, 25, 35, 45, 50, 55, 60, 75 min)
Comparison of glycemic response (from blood glucose) during exercise and early recovery between each exercise strategy.
Number of Participants With Hypoglycemia (<70 mg/dL) During Exercise and Early Recovery
Time frame · 0 to 75 minutes following exercise initiation
Comparison of occurrence of hypoglycemia (\<70 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.
Number of Participants With Hyperglycemia (≥250 mg/dL) During Exercise and Early Recovery
Time frame · 0 to 75 minutes following exercise initiation
Comparison of occurrence of hyperglycemia (≥250 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.
Continuous Glucose Monitor (CGM) Metrics During Late Recovery - Nadir Glucose
Time frame · 90 min after the standard meal until 1200 noon the day after each exercise session
Comparison of nadir glucose from CGM between the exercise strategies.
CGM Metrics During Late Recovery - Peak Glucose
Time frame · 90 min after the standard meal until 1200 noon the day after each exercise session
Comparison of peak glucose from CGM between the exercise strategies.
CGM Metrics During Late Recovery - Mean Glucose
Time frame · 90 min after the standard meal until 1200 noon the day after each exercise session
Comparison of mean glucose from CGM between the exercise strategies.
CGM Metrics During Late Recovery - Coefficient of Variation
Time frame · 90 min after the standard meal until 1200 noon the day after each exercise session
Comparison of the coefficient of variation from CGM between the exercise strategies.
CGM Metrics During Late Recovery - Time < 54 mg/dL
Time frame · 90 min after the standard meal until 1200 noon the day after each exercise session
Comparison of percentage of time \< 54 mg/dL from CGM between the exercise strategies.
CGM Metrics During Late Recovery - Time < 70 mg/dL
Time frame · 90 min after the standard meal until 1200 noon the day after each exercise session
Comparison of percentage of time \< 70 mg/dL from CGM between the exercise strategies.
CGM Metrics During Late Recovery - Time in Range (70-180 mg/dL)
Time frame · 90 min after the standard meal until 1200 noon the day after each exercise session
Comparison of percentage of time in range (70-180 mg/dL) from CGM between the exercise strategies.
CGM Metrics During Late Recovery - Time > 180 mg/dL
Time frame · 90 min after the standard meal until 1200 noon the day after each exercise session
Comparison of percentage of time \> 180 mg/dL from CGM between the exercise strategies.
CGM Metrics During Late Recovery - Time > 250 mg/dL
Time frame · 90 min after the standard meal until 1200 noon the day after each exercise session
Comparison of percentage of time \> 250 mg/dL from CGM between the exercise strategies.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Control | 86 | 30 |
| Basal Insulin Reduction | 85 | 25 |
| Glucose Tabs | 174 | 59 |
| G-Pen Mini™ (Glucagon Injection) | 161 | 39 |
| Group | Value (Participants) |
|---|---|
| Control | 6 |
| Basal Insulin Reduction | 5 |
| Glucose Tabs | 0 |
| G-Pen Mini™ (Glucagon Injection) | 0 |
| Group | Value (Participants) |
|---|---|
| Control | 0 |
| Basal Insulin Reduction | 0 |
| Glucose Tabs | 5 |
| G-Pen Mini™ (Glucagon Injection) | 1 |
| Group | Value (mg/dL) |
|---|---|
| Control | 45 |
| Basal Insulin Reduction | 44 |
| Glucose Tabs | 49 |
| G-Pen Mini™ (Glucagon Injection) | 51 |
| Group | Value (mg/dL) |
|---|---|
| Control | 241 |
| Basal Insulin Reduction | 239 |
| Glucose Tabs | 267 |
| G-Pen Mini™ (Glucagon Injection) | 269 |
| Group | Value (mg/dL) |
|---|---|
| Control | 129 |
| Basal Insulin Reduction | 139 |
| Glucose Tabs | 130 |
| G-Pen Mini™ (Glucagon Injection) | 147 |
| Group | Value (percentage) |
|---|---|
| Control | 32 |
| Basal Insulin Reduction | 35 |
| Glucose Tabs | 36 |
| G-Pen Mini™ (Glucagon Injection) | 33 |
| Group | Value (percentage) | Spread |
|---|---|---|
| Control | 3 | 3 |
| Basal Insulin Reduction | 3 | 3 |
| Glucose Tabs | 3 | 1 |
| G-Pen Mini™ (Glucagon Injection) | 2 | 2 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| ControlNo basal insulin adjustment, no carbohydrate intake (until glucose drops \<70 mg/dL). | 0 / 15 | 0 / 15 | 0 / 15 |
| Basal Insulin ReductionBasal insulin reduction to 50% 5 minutes before the start of exercise. | 0 / 15 | 0 / 15 | 0 / 15 |
| Glucose TabsDextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams). | 0 / 15 | 0 / 15 | 0 / 15 |
| G-Pen Mini™ (Glucagon Injection)Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen). | 0 / 15 | 0 / 15 | 0 / 15 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2018
Rickels et al. 2018Diabetes carecited by 58
PMID 29776987PMC6463733DOI 10.2337/dc18-0051PUB-29776987
1 study on this page
Indexing hint: Clinical trial · 2001
Haymond et al. 2001Diabetes carecited by 71
PMID 11315823DOI 10.2337/diacare.24.4.643PUB-11315823
Who could join, as posted.
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