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Trial · Interventional

CompletedPhase 2Results postedRegistry data

The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes

NCTNCT02660242 (opens ClinicalTrials.gov in a new tab)Other idT1DX Mini-dose Exercise

Overview

Status
Completed
Phase
Phase 2
Enrollment
16 participants (actual)
Sponsor
Jaeb Center for Health Research · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
Jan 2016
Primary completion
15 Feb 2017
Completion
15 Feb 2017
First posted
21 Jan 2016 (estimated)
Last update posted
3 Mar 2020
Conditions
Diabetes Mellitus, Type 1

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201620172018
  1. Ph 2

    The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes

    NCT02660242

    Jan 2016 to 15 Feb 2017

Registry summary

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.

Interventions

  • G-Pen Mini™ (glucagon injection)Drug
  • Glucose TabsOther
  • Basal Insulin ReductionOther

Arms4

  • 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).

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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)

    Registry description

    Comparison of glycemic response (from blood glucose) during exercise and early recovery between each exercise strategy.

Secondary outcomes(11)
  1. Number of Participants With Hypoglycemia (<70 mg/dL) During Exercise and Early Recovery

    Time frame · 0 to 75 minutes following exercise initiation

    Registry description

    Comparison of occurrence of hypoglycemia (\<70 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.

  2. Number of Participants With Hyperglycemia (≥250 mg/dL) During Exercise and Early Recovery

    Time frame · 0 to 75 minutes following exercise initiation

    Registry description

    Comparison of occurrence of hyperglycemia (≥250 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.

  3. 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

    Registry description

    Comparison of nadir glucose from CGM between the exercise strategies.

  4. CGM Metrics During Late Recovery - Peak Glucose

    Time frame · 90 min after the standard meal until 1200 noon the day after each exercise session

    Registry description

    Comparison of peak glucose from CGM between the exercise strategies.

  5. CGM Metrics During Late Recovery - Mean Glucose

    Time frame · 90 min after the standard meal until 1200 noon the day after each exercise session

    Registry description

    Comparison of mean glucose from CGM between the exercise strategies.

  6. 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

    Registry description

    Comparison of the coefficient of variation from CGM between the exercise strategies.

  7. 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

    Registry description

    Comparison of percentage of time \< 54 mg/dL from CGM between the exercise strategies.

  8. 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

    Registry description

    Comparison of percentage of time \< 70 mg/dL from CGM between the exercise strategies.

  9. 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

    Registry description

    Comparison of percentage of time in range (70-180 mg/dL) from CGM between the exercise strategies.

  10. 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

    Registry description

    Comparison of percentage of time \> 180 mg/dL from CGM between the exercise strategies.

  11. 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

    Registry description

    Comparison of percentage of time \> 250 mg/dL from CGM between the exercise strategies.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 0 to 75 minutes following exercise initiation (0, 5, 10, 15, 25, 35, 45, 50, 55, 60, 75 min)

Glycemic Response During Exercise and Early Recovery

GroupValue (mg/dL)Spread
Control8630
Basal Insulin Reduction8525
Glucose Tabs17459
G-Pen Mini™ (Glucagon Injection)16139
Secondary and other outcome results(7)
Secondary outcomeCount of participants· 0 to 75 minutes following exercise initiation

Number of Participants With Hypoglycemia (<70 mg/dL) During Exercise and Early Recovery

GroupValue (Participants)
Control6
Basal Insulin Reduction5
Glucose Tabs0
G-Pen Mini™ (Glucagon Injection)0
Secondary outcomeCount of participants· 0 to 75 minutes following exercise initiation

Number of Participants With Hyperglycemia (≥250 mg/dL) During Exercise and Early Recovery

GroupValue (Participants)
Control0
Basal Insulin Reduction0
Glucose Tabs5
G-Pen Mini™ (Glucagon Injection)1
Secondary outcomeMedian· 90 min after the standard meal until 1200 noon the day after each exercise session

Continuous Glucose Monitor (CGM) Metrics During Late Recovery - Nadir Glucose

GroupValue (mg/dL)
Control45
Basal Insulin Reduction44
Glucose Tabs49
G-Pen Mini™ (Glucagon Injection)51
Secondary outcomeMedian· 90 min after the standard meal until 1200 noon the day after each exercise session

CGM Metrics During Late Recovery - Peak Glucose

GroupValue (mg/dL)
Control241
Basal Insulin Reduction239
Glucose Tabs267
G-Pen Mini™ (Glucagon Injection)269
Secondary outcomeMedian· 90 min after the standard meal until 1200 noon the day after each exercise session

CGM Metrics During Late Recovery - Mean Glucose

GroupValue (mg/dL)
Control129
Basal Insulin Reduction139
Glucose Tabs130
G-Pen Mini™ (Glucagon Injection)147
Secondary outcomeMedian· 90 min after the standard meal until 1200 noon the day after each exercise session

CGM Metrics During Late Recovery - Coefficient of Variation

GroupValue (percentage)
Control32
Basal Insulin Reduction35
Glucose Tabs36
G-Pen Mini™ (Glucagon Injection)33
Secondary outcomeMean· 90 min after the standard meal until 1200 noon the day after each exercise session

CGM Metrics During Late Recovery - Time < 54 mg/dL

GroupValue (percentage)Spread
Control33
Basal Insulin Reduction33
Glucose Tabs31
G-Pen Mini™ (Glucagon Injection)22

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
ControlNo basal insulin adjustment, no carbohydrate intake (until glucose drops \<70 mg/dL).0 / 150 / 150 / 15
Basal Insulin ReductionBasal insulin reduction to 50% 5 minutes before the start of exercise.0 / 150 / 150 / 15
Glucose TabsDextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).0 / 150 / 150 / 15
G-Pen Mini™ (Glucagon Injection)Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).0 / 150 / 150 / 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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

9 results

Mini-Dose Glucagon as a Novel Approach to Prevent Exercise-Induced Hypoglycemia in Type 1 Diabetes.

Rickels et al. 2018Diabetes carecited by 58

PMID 29776987PMC6463733DOI 10.2337/dc18-0051PUB-29776987

Rights unknown9 results

More studies

1 study on this page

Indexing hint: Clinical trial · 2001

Mini-dose glucagon rescue for hypoglycemia in children with type 1 diabetes.

Haymond et al. 2001Diabetes carecited by 71

PMID 11315823DOI 10.2337/diacare.24.4.643PUB-11315823

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 64 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 discontinue pump use during the study 6. Exercises regularly, i.e. ≥30 minutes moderate or more vigorous aerobic activity X ≥3 times/week 7. Body mass index (BMI) \<30 kg/m2 8. Females must meet one of the following criteria: * Of childbearing potential and not currently pregnant or lactating, and agrees to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study; or * Of non-childbearing potential, defined as a female who has had a hysterectomy or tubal ligation, is clinically considered infertile or is in a menopausal state (at least 1 year without menses) 9. In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations 10. Willing to adhere to the protocol requirements for the duration of the study 11. Must be enrolled in the T1D Exchange clinic registry or willing to join the registry Exclusion Criteria: 1. One or more severe hypoglycemic episodes in the past 12 months (as defined by an episode that required third party assistance for treatment) 2. Active diabetic retinopathy (proliferative diabetic retinopathy or vitreous hemorrhage in past 6 months) that could potentially be worsened by exercise protocol 3. Peripheral neuropathy with insensate feet 4. Cardiovascular autonomic neuropathy with inappropriate heart rate response to exercise 5. Use of non-insulin anti-diabetic medications 6. Use of beta-blockers 7. Use of agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives 8. Use of Pramlintide 9. Currently following a very low calorie or other weight-loss diet 10. Participation in other studies involving administration of an investigational drug or device within 30 days or 5 half-lives, whichever is longer, before screening for the current study or planning to participate in another such study during participation in the current study

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