Diabetes Mellitus, Type 1Phase 2NCT02660242
The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes
A Phase 2 study testing G-Pen Mini™ (glucagon injection), Glucose Tabs and Basal Insulin Reduction in people with Diabetes Mellitus, Type 1, run by Jaeb Center for Health Research at 2 sites in United States.
Trial summary
This project focuses on development of new strategy for the prevention of exercise-associated hypoglycemia using mini-dose glucagon. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- G-Pen Mini™ (glucagon injection), Glucose Tabs and Basal Insulin Reduction
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to 15 Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin
- Age 18-<65 years
- Duration of T1D ≥ 2 years
- Random C-peptide < 0.6 ng/ml
- Using continuous subcutaneous insulin infusion (CSII; insulin pump) for at least 6 months, with no plans to discontinue pump use during the study
- Exercises regularly, i.e. ≥30 minutes moderate or more vigorous aerobic activity X ≥3 times/week
Show all 13Show fewer
- Body mass index (BMI) <30 kg/m2
- 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)
- 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
- Willing to adhere to the protocol requirements for the duration of the study
- Must be enrolled in the T1D Exchange clinic registry or willing to join the registry
Who cannot join
- One or more severe hypoglycemic episodes in the past 12 months (as defined by an episode that required third party assistance for treatment)
- Active diabetic retinopathy (proliferative diabetic retinopathy or vitreous hemorrhage in past 6 months) that could potentially be worsened by exercise protocol
- Peripheral neuropathy with insensate feet
- Cardiovascular autonomic neuropathy with inappropriate heart rate response to exercise
- Use of non-insulin anti-diabetic medications
- Use of beta-blockers
Show all 10Show fewer
- Use of agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives
- Use of Pramlintide
- Currently following a very low calorie or other weight-loss diet
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Joslin Diabetes Center
Boston, Massachusetts, 02215
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This project focuses on development of new strategy for the prevention of exercise-associated hypoglycemia using mini-dose glucagon.
Read the detailed description
The primary objective of the protocol is to determine if the administration of mini-dose glucagon administered subcutaneously just before exercise produces better glucose stability than no adjustments for moderate intensity exercise in patients with Type 1 Diabetes (T1D). It will also be assessed whether mini-dose glucagon before exercise produces better glucose stability than basal insulin reductions or extra carbohydrate consumption.
This is a randomized, 4-way crossover trial. The trial will include 16 participants who complete the study.
Each participant will undergo four aerobic exercise sessions (in random order), with different strategies for glucose regulation:
- Control Trial: Fasted exercise, no basal insulin reduction
- Strategy 1: Fasted exercise, basal insulin reduction only (50% reduction in basal rate at 60 minutes before exercise, for the duration of the exercise)
- Strategy 2: Fasted exercise, no basal adjustment + pre-exercise glucose tabs (buccal route-40 grams in total )
- Strategy 3: Fasted exercise, no basal adjustment + pre-exercise mini-dose glucagon (sc)
In all 4 sessions, aerobic exercise will be performed in the fasted state (before a standardized meal) for 45 minuets at ~50-55% of the participant's per-determined aerobic capacity. The participant's pump will be blinded during the control trial, strategy 1, and strategy 3 and an injection of saline will be given during the control trial and strategy 1 so that participant is blinded to strategy.
The primary outcome for this study will be the glycemic response during exercise and early recovery.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- G-Pen Mini™ (glucagon injection), Glucose Tabs, Basal Insulin Reduction
- Keywords
- T1D, Type 1 Diabetes, Mini-dose Glucagon, Adults, Exercise, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-Pen Mini™ (glucagon injection)Drug
Also called mini-dose glucagon
Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
Glucose TabsOther
Also called over-the-counter oral glucose tablets
Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
Basal Insulin ReductionOther
Basal insulin reduction to 50% 5 minutes before the start of exercise.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Basal Insulin Reduction |
| 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). Receives: Other: Glucose Tabs |
| G-Pen Mini™ (glucagon injection) | Experimental | Glucagon (150 µg) five minutes before the start of exercise (SQ-abdomen). Receives: Drug: G-Pen Mini™ (glucagon injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Response During Exercise and Early Recovery
Comparison of glycemic response (from blood glucose) during exercise and early recovery between each exercise strategy.
Measured: 0 to 75 minutes following exercise initiation (0, 5, 10, 15, 25, 35, 45, 50, 55, 60, 75 min)
Secondary outcomes (11)
Number of Participants With Hypoglycemia (<70 mg/dL) During Exercise and Early Recovery
Comparison of occurrence of hypoglycemia (<70 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.
Measured: 0 to 75 minutes following exercise initiation
Number of Participants With Hyperglycemia (≥250 mg/dL) During Exercise and Early Recovery
Comparison of occurrence of hyperglycemia (≥250 mg/dL from blood glucose) during exercise and early recovery between each exercise strategy.
Measured: 0 to 75 minutes following exercise initiation
Continuous Glucose Monitor (CGM) Metrics During Late Recovery - Nadir Glucose
Comparison of nadir glucose from CGM between the exercise strategies.
Measured: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Peak Glucose
Comparison of peak glucose from CGM between the exercise strategies.
Measured: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Mean Glucose
Comparison of mean glucose from CGM between the exercise strategies.
Measured: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Coefficient of Variation
Comparison of the coefficient of variation from CGM between the exercise strategies.
Measured: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Time < 54 mg/dL
Comparison of percentage of time < 54 mg/dL from CGM between the exercise strategies.
Measured: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Time < 70 mg/dL
Comparison of percentage of time < 70 mg/dL from CGM between the exercise strategies.
Measured: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Time in Range (70-180 mg/dL)
Comparison of percentage of time in range (70-180 mg/dL) from CGM between the exercise strategies.
Measured: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Time > 180 mg/dL
Comparison of percentage of time > 180 mg/dL from CGM between the exercise strategies.
Measured: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Time > 250 mg/dL
Comparison of percentage of time > 250 mg/dL from CGM between the exercise strategies.
Measured: 90 min after the standard meal until 1200 noon the day after each exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion15 Feb 2017
- Study completion15 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Xeris Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Michael Riddell, PhD, Study chair, York UniversityMichael Rickels, M.D., M.S., Study chair, University of PennsylvaniaHoward Wolpert, M.D., Study chair, Joslin Diabetes CenterStephanie DuBose, M.P.H, Principal investigator, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02660242
- Sponsor's protocol ID
- T1DX Mini-dose Exercise
- Status last verified
- Feb 2020
- First submitted
- 6 Jan 2016
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Chu L, Hamilton J, Riddell MC. Clinical management of the physically active patient with type 1 diabetes. Phys Sportsmed. 2011 May;39(2):64-77. doi: 10.3810/psm.2011.05.1896.
PubMed 21673486West DJ, Morton RD, Bain SC, Stephens JW, Bracken RM. Blood glucose responses to reductions in pre-exercise rapid-acting insulin for 24 h after running in individuals with type 1 diabetes. J Sports Sci. 2010 May;28(7):781-8. doi: 10.1080/02640411003734093.
PubMed 20496226Brazeau AS, Rabasa-Lhoret R, Strychar I, Mircescu H. Barriers to physical activity among patients with type 1 diabetes. Diabetes Care. 2008 Nov;31(11):2108-9. doi: 10.2337/dc08-0720. Epub 2008 Aug 8.
PubMed 18689694Rabasa-Lhoret R, Bourque J, Ducros F, Chiasson JL. Guidelines for premeal insulin dose reduction for postprandial exercise of different intensities and durations in type 1 diabetic subjects treated intensively with a basal-bolus insulin regimen (ultralente-lispro). Diabetes Care. 2001 Apr;24(4):625-30. doi: 10.2337/diacare.24.4.625.
PubMed 11315820Campbell MD, Walker M, Trenell MI, Jakovljevic DG, Stevenson EJ, Bracken RM, Bain SC, West DJ. Large pre- and postexercise rapid-acting insulin reductions preserve glycemia and prevent early- but not late-onset hypoglycemia in patients with type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2217-24. doi: 10.2337/dc12-2467. Epub 2013 Mar 20.
PubMed 23514728Stenerson M, Cameron F, Payne SR, Payne SL, Ly TT, Wilson DM, Buckingham BA. The impact of accelerometer use in exercise-associated hypoglycemia prevention in type 1 diabetes. J Diabetes Sci Technol. 2015 Jan;9(1):80-5. doi: 10.1177/1932296814551045. Epub 2014 Sep 17.
PubMed 25231116Tsalikian E, Mauras N, Beck RW, Tamborlane WV, Janz KF, Chase HP, Wysocki T, Weinzimer SA, Buckingham BA, Kollman C, Xing D, Ruedy KJ; Diabetes Research In Children Network Direcnet Study Group. Impact of exercise on overnight glycemic control in children with type 1 diabetes mellitus. J Pediatr. 2005 Oct;147(4):528-34. doi: 10.1016/j.jpeds.2005.04.065.
PubMed 16227041Tanenberg RJ, Newton CA, Drake AJ. Confirmation of hypoglycemia in the "dead-in-bed" syndrome, as captured by a retrospective continuous glucose monitoring system. Endocr Pract. 2010 Mar-Apr;16(2):244-8. doi: 10.4158/EP09260.CR.
PubMed 19833577Campbell MD, Walker M, Trenell MI, Luzio S, Dunseath G, Tuner D, Bracken RM, Bain SC, Russell M, Stevenson EJ, West DJ. Metabolic implications when employing heavy pre- and post-exercise rapid-acting insulin reductions to prevent hypoglycaemia in type 1 diabetes patients: a randomised clinical trial. PLoS One. 2014 May 23;9(5):e97143. doi: 10.1371/journal.pone.0097143. eCollection 2014.
PubMed 24858952Taplin CE, Cobry E, Messer L, McFann K, Chase HP, Fiallo-Scharer R. Preventing post-exercise nocturnal hypoglycemia in children with type 1 diabetes. J Pediatr. 2010 Nov;157(5):784-8.e1. doi: 10.1016/j.jpeds.2010.06.004. Epub 2010 Jul 21.
PubMed 20650471Riddell MC, Bar-Or O, Ayub BV, Calvert RE, Heigenhauser GJ. Glucose ingestion matched with total carbohydrate utilization attenuates hypoglycemia during exercise in adolescents with IDDM. Int J Sport Nutr. 1999 Mar;9(1):24-34. doi: 10.1123/ijsn.9.1.24.
PubMed 10036339Robertson K, Riddell MC, Guinhouya BC, Adolfsson P, Hanas R; International Society for Pediatric and Adolescent Diabetes. ISPAD Clinical Practice Consensus Guidelines 2014. Exercise in children and adolescents with diabetes. Pediatr Diabetes. 2014 Sep;15 Suppl 20:203-23. doi: 10.1111/pedi.12176. No abstract available.
PubMed 25182315Camacho RC, Galassetti P, Davis SN, Wasserman DH. Glucoregulation during and after exercise in health and insulin-dependent diabetes. Exerc Sport Sci Rev. 2005 Jan;33(1):17-23.
PubMed 15640716Oskarsson PR, Lins PE, Wallberg Henriksson H, Adamson UC. Metabolic and hormonal responses to exercise in type 1 diabetic patients during continuous subcutaneous, as compared to continuous intraperitoneal, insulin infusion. Diabetes Metab. 1999 Dec;25(6):491-7.
PubMed 10633873Haymond MW, Schreiner B. Mini-dose glucagon rescue for hypoglycemia in children with type 1 diabetes. Diabetes Care. 2001 Apr;24(4):643-5. doi: 10.2337/diacare.24.4.643.
PubMed 11315823
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02660242
- Acronym / sponsor ID
- T1DX Mini-dose Exercise
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- T1D, Type 1 Diabetes, Mini-dose Glucagon, Adults, Exercise, Hypoglycemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Xeris Pharmaceuticals
- Study start
- Jan 2016
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 15 Feb 2017 (actual)
- First posted
- 21 Jan 2016 (estimated)
- Results
- Posted 7 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project focuses on development of new strategy for the prevention of exercise-associated hypoglycemia using mini-dose glucagon.
Detailed description
The primary objective of the protocol is to determine if the administration of mini-dose glucagon administered subcutaneously just before exercise produces better glucose stability than no adjustments for moderate intensity exercise in patients with Type 1 Diabetes (T1D). It will also be assessed whether mini-dose glucagon before exercise produces better glucose stability than basal insulin reductions or extra carbohydrate consumption.
This is a randomized, 4-way crossover trial. The trial will include 16 participants who complete the study.
Each participant will undergo four aerobic exercise sessions (in random order), with different strategies for glucose regulation:
- Control Trial: Fasted exercise, no basal insulin reduction
- Strategy 1: Fasted exercise, basal insulin reduction only (50% reduction in basal rate at 60 minutes before exercise, for the duration of the exercise)
- Strategy 2: Fasted exercise, no basal adjustment + pre-exercise glucose tabs (buccal route-40 grams in total )
- Strategy 3: Fasted exercise, no basal adjustment + pre-exercise mini-dose glucagon (sc)
In all 4 sessions, aerobic exercise will be performed in the fasted state (before a standardized meal) for 45 minuets at ~50-55% of the participant's per-determined aerobic capacity. The participant's pump will be blinded during the control trial, strategy 1, and strategy 3 and an injection of saline will be given during the control trial and strategy 1 so that participant is blinded to strategy.
The primary outcome for this study will be the glycemic response during exercise and early recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No basal insulin adjustment, no carbohydrate intake (until glucose drops <70 mg/dL). |
| Basal insulin reduction | Active comparator | Other: Basal Insulin ReductionBasal insulin reduction to 50% five minutes before the start of exercise. |
| Glucose Tabs | Active comparator | Other: Glucose TabsDextrose 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 | Drug: G-Pen Mini™ (glucagon injection)Glucagon (150 µg) five minutes before the start of exercise (SQ-abdomen). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin
- Age 18-<65 years
- Duration of T1D ≥ 2 years
- Random C-peptide < 0.6 ng/ml
- Using continuous subcutaneous insulin infusion (CSII; insulin pump) for at least 6 months, with no plans to discontinue pump use during the study
Key exclusion criteria (10 listed)
- One or more severe hypoglycemic episodes in the past 12 months (as defined by an episode that required third party assistance for treatment)
- Active diabetic retinopathy (proliferative diabetic retinopathy or vitreous hemorrhage in past 6 months) that could potentially be worsened by exercise protocol
- Peripheral neuropathy with insensate feet
- Cardiovascular autonomic neuropathy with inappropriate heart rate response to exercise
- Use of non-insulin anti-diabetic medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-Pen Mini™ (glucagon injection)Also: mini-dose glucagonGlucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen). | Drug | G-Pen Mini™ (glucagon injection) |
| Glucose TabsAlso: over-the-counter oral glucose tabletsDextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams). | Other | Glucose Tabs |
| Basal Insulin ReductionBasal insulin reduction to 50% 5 minutes before the start of exercise. | Other | Basal insulin reduction |
Primary outcome
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.
11 secondary outcomes
Number of Participants With Hypoglycemia (<70 mg/dL) During Exercise and Early Recovery
Time frame: 0 to 75 minutes following exercise initiation
Number of Participants With Hyperglycemia (≥250 mg/dL) During Exercise and Early Recovery
Time frame: 0 to 75 minutes following exercise initiation
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
CGM Metrics During Late Recovery - Peak Glucose
Time frame: 90 min after the standard meal until 1200 noon the day after each exercise session
CGM Metrics During Late Recovery - Mean Glucose
Time frame: 90 min after the standard meal until 1200 noon the day after each exercise session
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21673486Chu L, Hamilton J, Riddell MC. Clinical management of the physically active patient with type 1 diabetes. Phys Sportsmed. 2011 May;39(2):64-77. doi: 10.3810/psm.2011.05.1896.
- Background: PubMed 20496226West DJ, Morton RD, Bain SC, Stephens JW, Bracken RM. Blood glucose responses to reductions in pre-exercise rapid-acting insulin for 24 h after running in individuals with type 1 diabetes. J Sports Sci. 2010 May;28(7):781-8. doi: 10.1080/02640411003734093.
- Background: PubMed 18689694Brazeau AS, Rabasa-Lhoret R, Strychar I, Mircescu H. Barriers to physical activity among patients with type 1 diabetes. Diabetes Care. 2008 Nov;31(11):2108-9. doi: 10.2337/dc08-0720. Epub 2008 Aug 8.
- Background: PubMed 11315820Rabasa-Lhoret R, Bourque J, Ducros F, Chiasson JL. Guidelines for premeal insulin dose reduction for postprandial exercise of different intensities and durations in type 1 diabetic subjects treated intensively with a basal-bolus insulin regimen (ultralente-lispro). Diabetes Care. 2001 Apr;24(4):625-30. doi: 10.2337/diacare.24.4.625.
- Background: PubMed 23514728Campbell MD, Walker M, Trenell MI, Jakovljevic DG, Stevenson EJ, Bracken RM, Bain SC, West DJ. Large pre- and postexercise rapid-acting insulin reductions preserve glycemia and prevent early- but not late-onset hypoglycemia in patients with type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2217-24. doi: 10.2337/dc12-2467. Epub 2013 Mar 20.
- Background: PubMed 25231116Stenerson M, Cameron F, Payne SR, Payne SL, Ly TT, Wilson DM, Buckingham BA. The impact of accelerometer use in exercise-associated hypoglycemia prevention in type 1 diabetes. J Diabetes Sci Technol. 2015 Jan;9(1):80-5. doi: 10.1177/1932296814551045. Epub 2014 Sep 17.
- Background: PubMed 16227041Tsalikian E, Mauras N, Beck RW, Tamborlane WV, Janz KF, Chase HP, Wysocki T, Weinzimer SA, Buckingham BA, Kollman C, Xing D, Ruedy KJ; Diabetes Research In Children Network Direcnet Study Group. Impact of exercise on overnight glycemic control in children with type 1 diabetes mellitus. J Pediatr. 2005 Oct;147(4):528-34. doi: 10.1016/j.jpeds.2005.04.065.
- Background: PubMed 19833577Tanenberg RJ, Newton CA, Drake AJ. Confirmation of hypoglycemia in the "dead-in-bed" syndrome, as captured by a retrospective continuous glucose monitoring system. Endocr Pract. 2010 Mar-Apr;16(2):244-8. doi: 10.4158/EP09260.CR.
- Background: PubMed 24858952Campbell MD, Walker M, Trenell MI, Luzio S, Dunseath G, Tuner D, Bracken RM, Bain SC, Russell M, Stevenson EJ, West DJ. Metabolic implications when employing heavy pre- and post-exercise rapid-acting insulin reductions to prevent hypoglycaemia in type 1 diabetes patients: a randomised clinical trial. PLoS One. 2014 May 23;9(5):e97143. doi: 10.1371/journal.pone.0097143. eCollection 2014.
- Background: PubMed 20650471Taplin CE, Cobry E, Messer L, McFann K, Chase HP, Fiallo-Scharer R. Preventing post-exercise nocturnal hypoglycemia in children with type 1 diabetes. J Pediatr. 2010 Nov;157(5):784-8.e1. doi: 10.1016/j.jpeds.2010.06.004. Epub 2010 Jul 21.
- Background: PubMed 10036339Riddell MC, Bar-Or O, Ayub BV, Calvert RE, Heigenhauser GJ. Glucose ingestion matched with total carbohydrate utilization attenuates hypoglycemia during exercise in adolescents with IDDM. Int J Sport Nutr. 1999 Mar;9(1):24-34. doi: 10.1123/ijsn.9.1.24.
- Background: PubMed 25182315Robertson K, Riddell MC, Guinhouya BC, Adolfsson P, Hanas R; International Society for Pediatric and Adolescent Diabetes. ISPAD Clinical Practice Consensus Guidelines 2014. Exercise in children and adolescents with diabetes. Pediatr Diabetes. 2014 Sep;15 Suppl 20:203-23. doi: 10.1111/pedi.12176. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Riddell, PhD study chair
York University
Michael Rickels, M.D., M.S. study chair
University of Pennsylvania
Howard Wolpert, M.D. study chair
Joslin Diabetes Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing G-Pen Mini™ (glucagon injection), Glucose Tabs and Basal Insulin Reduction in people with Diabetes Mellitus, Type 1, run by Jaeb Center for Health Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02660242, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.