Type 1 Diabetes MellitusPhase 4FIT UntetheredNCT03838783
Flexible Insulin Therapy Untethered Insulin Regimen in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered
A Phase 4 study testing Insulin Degludec in people with Type 1 Diabetes Mellitus, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
Trial summary
The overall objective of this study is to evaluate glycemic control and patient-reported outcomes in patients with Type 1 diabetes (T1D) who use insulin degludec and continuous subcutaneous insulin infusion in a combination untethered regimen during moderate or high-intensity exercise. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Insulin Degludec
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2018to 30 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults with clinical diagnosis of T1D
- Age 18-55 years, inclusive
- Diagnosis of T1D ≥ 6 months
- A1c ≤ 8.5% at screening visit
- Using stable CSII therapy for ≥ 6 months
- Exercise regularly (≥ 3 times per week of moderate or vigorous exercise)
Show all 10Show fewer
- VO2peak ≥ 30 ml/kg/min for females and ≥ 32 ml/kg/min for males
- Willing to adhere to the protocol requirements for the duration of the study
- Written informed consent
- Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at screening visit
Who cannot join
- Pregnant or lactating
- Already using a split regimen of combination CSII and basal insulin injection
- Active diabetic retinopathy (proliferated diabetic retinopathy, or vitreous hemorrhage in past 6 months) that could potentially be worsened by the exercise protocol
- Any evidence of unstable cardiovascular disease, disorders or abnormalities as per physician's discretion
- Currently following a very low calorie or other weight-loss diet which may impact glucose control and mask the primary and secondary outcome measures
- More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months
Show all 13Show fewer
- Known hypoglycemia unawareness
- Use of acetaminophen (Tylenol) during the study period
- Medications other than insulin that might impact outcome measures:
- Beta blockers
- Any agents that affect hepatic glucose production, including all beta adrenergic agonists or antagonists, all xanthine derivatives
- Pramlintide
- Any non-insulin diabetes therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
LMC Diabetes & Endocrinology Ltd.
Toronto, Ontario, M4G 3E8
Nichole Mckay, MSc
About this study
Official title: Flexible Insulin Therapy Untethered Insulin Regimen Using Insulin Degludec and Continuous Subcutaneous Insulin Infusion in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered
The overall objective of this study is to evaluate glycemic control and patient-reported outcomes in patients with Type 1 diabetes (T1D) who use insulin degludec and continuous subcutaneous insulin infusion in a combination untethered regimen during moderate or high-intensity exercise.
Read the detailed description
FIT untethered is an open-label, randomized, repeated measures cross-over design study, testing glycemic control in "untethered" continuous subcutaneous insulin infusion (CSII) therapy compared to usual CSII therapy, in physically active patients with T1D (N=30). During 2-week screening visits, participants are randomized into either the usual CSII arm or the untethered CSII arm. Patients in the usual group continue with their established CSII therapy. Patients in the untethered group are to administer 50% of their basal dose through an insulin degludec injection every morning, with the other 50% achieved through their established CSII therapy. Bolus insulin remains at the established dose in both groups. After randomization, patients begin Phase I and transition into a 2-week insulin optimization period. Then, participants will complete 2 in-clinic, supervised exercise visits (1 moderate and 1 high intensity exercises) in the following week. After, participants must complete 2 unsupervised at-home exercises per week for 3 weeks (cumulative total of 2 moderate and 4 high intensity exercises). After the home exercise period, participants cross-over to the other study arm and begin Phase II. Phase II is similar to Phase I: 2 weeks of insulin dose optimization, 1 week of supervised clinic exercise, and 3 weeks of unsupervised home exercise. For both in-clinic and home-based exercise, the participant's insulin pump will be disconnected and suspended 60 minutes prior to beginning the workout, and will be reconnected immediately following each workout. A continuous glucose monitoring (CGM) device will be worn by each participant for the entire duration of the study. The co-primary outcomes of the study include time in range (4.0 - 10.0 mmol/L) in the 6 hours after the start of moderate- and high-intensity exercise. The key secondary outcomes include the glucose variability during the 24 hour period after the start of both moderate and high intensity exercise, and patient reported outcomes before and after exercise.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Insulin Degludec
- Keywords
- Exercise, Insulin Degludec, Continuous glucose monitoring (CGM), Continuous Subcutaneous Insulin Infusion (CSII)
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin DegludecDrug
Also called Tresiba
50% of the patient's daily basal insulin dose delivered through once daily insulin degludec injected in the morning; 50% of the basal insulin to be delivered through previously established CSII
| Study group | Role | What they receive |
|---|---|---|
| Usual CSII | No intervention | Continue to use the established CSII insulin therapy |
| Untethered CSII | Experimental | Basal dosing - total CSII basal dose will be delivered by 50% through continuing CSII therapy used prior to study enrollment and 50% through the addition of once daily insulin degludec injected in the morning; Bolus dosing - continue the established bolus insulin dose Receives: Drug: Insulin Degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range within 6 hours
Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L within 6 hours after the start of high-intensity or moderate-intensity, in-clinic exercise
Measured: 6 hours
Secondary outcomes (11)
Change in glucose within 60 mins after high-intensity exercise starts
Plasma glucose at 30 mins after after the end of a 30-min high-intensity, in-clinic exercise minus plasma glucose at baseline (right before exercise)
Measured: 60 mins
Change in glucose within 120 mins after moderate-intensity exercise starts
Plasma glucose at 30 mins after the end of a 90-min moderate-intensity, in-clinic exercise minus plasma glucose at baseline (right before exercise)
Measured: 120 mins
Time spent in hypoglycemia 24 hours after exercise
Percentage of time with CGM glucose <4.0 mmol/L within 24 hour after the start of high intensity exercise or moderate intensity in-clinic exercise
Measured: 24 hours
Time in range 24 hours after exercise
Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L within 24 hour after the start of high intensity exercise or moderate intensity in-clinic exercise
Measured: 24 hours
Time spent in hyperglycemia 24 hours after exercise
Percentage of time with CGM glucose > 10.0 mmol/L within 24 hour after the start of high intensity exercise or moderate intensity in-clinic exercise
Measured: 24 hours
Time in range in the last 4 weeks of each study phase
Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L in the last 4 weeks of each study phase
Measured: 4 weeks
Frequency of hypoglycemia 24 hours after exercise
Number of hypoglycemic episodes, which are defined as CGM glucose <4.0 mmol/L lasting ≥15 minutes within 24 hours following high intensity exercise or moderate intensity in-clinic exercise
Measured: 24 hours
Frequency of hypoglycemia in the last 4 weeks of each study phase
Number of hypoglycemic episodes, which are defined as CGM glucose <4.0 mmol/L lasting ≥15 minutes in the last 4 weeks of each study phase
Measured: 4 weeks
Change in Diabetes Medication Satisfaction (DiabMedSat) Score
Diabetes Medication Satisfaction questionnaire is to measure the level of patients' satisfaction with their diabetes medication(s) in the past 2 weeks. The score range will be 0 to 100. The higher the score, the less the satisfaction.
The change of scores is the score difference between Visit 24 and Visit 2
Measured: 11 weeks
Change in Hypoglycemia Fear Score
Hypoglycemia Fear will be measured by the Hypoglycemia Fear Survey which assesses the subject's behaviors to avoid hypoglycemia and to measure the subjects' worries about hypoglycemia and its consequences in the past 3 months. The range of the score will be 0 to 132. The higher the score, the greater the fear.
The changes of scores are the score difference between Visit 24 and Visit 2
Measured: 11 weeks
Change in TRIM-D Score
Treatment Related Impact Measure - Diabetes Device (TRIM-D Device) questionnaire will be used to generate TRIM-D-Score. It measures the level of the subject's satisfaction with the device used to take the diabetes medication. The range of this score will be 3-15. The higher the score, The greater satisfaction.
The changes of scores are the score difference between Visit 24 and Visit 2
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start15 May 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomization for the sequence of Interventions (A and B) will be done by an interactive system that will randomly assign patients to an intervention sequence.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronnie Aronson, MD, LMC Diabetes & Endocrinology Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838783
- Sponsor's protocol ID
- FIT Untethered
- Acronym
- FIT Untethered
- Status last verified
- Feb 2019
- First submitted
- 26 Jul 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doyle EA, Weinzimer SA, Steffen AT, Ahern JA, Vincent M, Tamborlane WV. A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care. 2004 Jul;27(7):1554-8. doi: 10.2337/diacare.27.7.1554.
PubMed 15220227Binek A, Rembierz-Knoll A, Polanska J, Jarosz-Chobot P. Reasons for the discontinuation of therapy of personal insulin pump in children with type 1 diabetes. Pediatr Endocrinol Diabetes Metab. 2016 Feb 18;21(2):65-9. doi: 10.18544/PEDM-21.02.0026.
PubMed 26901138Wong JC, Boyle C, DiMeglio LA, Mastrandrea LD, Abel KL, Cengiz E, Cemeroglu PA, Aleppo G, Largay JF, Foster NC, Beck RW, Adi S; T1D Exchange Clinic Network. Evaluation of Pump Discontinuation and Associated Factors in the T1D Exchange Clinic Registry. J Diabetes Sci Technol. 2017 Mar;11(2):224-232. doi: 10.1177/1932296816663963. Epub 2016 Sep 25.
PubMed 27595711Benbenek-Klupa T, Matejko B, Klupa T. Metabolic control in type 1 diabetes patients practicing combat sports: at least two-year follow-up study. Springerplus. 2015 Mar 17;4:133. doi: 10.1186/s40064-015-0919-5. eCollection 2015.
PubMed 25825689Delvecchio M, Zecchino C, Salzano G, Faienza MF, Cavallo L, De Luca F, Lombardo F. Effects of moderate-severe exercise on blood glucose in Type 1 diabetic adolescents treated with insulin pump or glargine insulin. J Endocrinol Invest. 2009 Jun;32(6):519-24. doi: 10.1007/BF03346499.
PubMed 19474521Yardley JE, Zaharieva DP, Jarvis C, Riddell MC. The "ups" and "downs" of a bike race in people with type 1 diabetes: dramatic differences in strategies and blood glucose responses in the Paris-to-Ancaster Spring Classic. Can J Diabetes. 2015 Apr;39(2):105-10. doi: 10.1016/j.jcjd.2014.09.003. Epub 2014 Dec 6.
PubMed 25492557Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24.
PubMed 28126459Aronson R, Li A, Brown RE, McGaugh S, Riddell MC. Flexible insulin therapy with a hybrid regimen of insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise in physically active adults with type 1 diabetes (FIT Untethered): a single-centre, open-label, proof-of-concept, randomised crossover trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):511-523. doi: 10.1016/S2213-8587(20)30114-5.
PubMed 32445738
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible Insulin Therapy Untethered Insulin Regimen Using Insulin Degludec and Continuous Subcutaneous Insulin Infusion in Avidly Exercising Patients With Type 1 Diabetes: FIT Untethered
- ClinicalTrials.gov ID
- NCT03838783
- Acronym / sponsor ID
- FIT Untethered / FIT Untethered
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Exercise, Insulin Degludec, Continuous glucose monitoring (CGM), Continuous Subcutaneous Insulin Infusion (CSII)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.University, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to evaluate glycemic control and patient-reported outcomes in patients with Type 1 diabetes (T1D) who use insulin degludec and continuous subcutaneous insulin infusion in a combination untethered regimen during moderate or high-intensity exercise.
Detailed description
FIT untethered is an open-label, randomized, repeated measures cross-over design study, testing glycemic control in "untethered" continuous subcutaneous insulin infusion (CSII) therapy compared to usual CSII therapy, in physically active patients with T1D (N=30). During 2-week screening visits, participants are randomized into either the usual CSII arm or the untethered CSII arm. Patients in the usual group continue with their established CSII therapy. Patients in the untethered group are to administer 50% of their basal dose through an insulin degludec injection every morning, with the other 50% achieved through their established CSII therapy. Bolus insulin remains at the established dose in both groups. After randomization, patients begin Phase I and transition into a 2-week insulin optimization period. Then, participants will complete 2 in-clinic, supervised exercise visits (1 moderate and 1 high intensity exercises) in the following week. After, participants must complete 2 unsupervised at-home exercises per week for 3 weeks (cumulative total of 2 moderate and 4 high intensity exercises). After the home exercise period, participants cross-over to the other study arm and begin Phase II. Phase II is similar to Phase I: 2 weeks of insulin dose optimization, 1 week of supervised clinic exercise, and 3 weeks of unsupervised home exercise. For both in-clinic and home-based exercise, the participant's insulin pump will be disconnected and suspended 60 minutes prior to beginning the workout, and will be reconnected immediately following each workout. A continuous glucose monitoring (CGM) device will be worn by each participant for the entire duration of the study. The co-primary outcomes of the study include time in range (4.0 - 10.0 mmol/L) in the 6 hours after the start of moderate- and high-intensity exercise. The key secondary outcomes include the glucose variability during the 24 hour period after the start of both moderate and high intensity exercise, and patient reported outcomes before and after exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization for the sequence of Interventions (A and B) will be done by an interactive system that will randomly assign patients to an intervention sequence.
| Arm | Type | Receives |
|---|---|---|
| Usual CSII | No intervention | –Continue to use the established CSII insulin therapy |
| Untethered CSII | Experimental | Drug: Insulin DegludecBasal dosing - total CSII basal dose will be delivered by 50% through continuing CSII therapy used prior to study enrollment and 50% through the addition of once daily insulin degludec injected in the morning; Bolus dosing - continue the established bolus insulin dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adults with clinical diagnosis of T1D
- Age 18-55 years, inclusive
- Diagnosis of T1D ≥ 6 months
- A1c ≤ 8.5% at screening visit
- Using stable CSII therapy for ≥ 6 months
Key exclusion criteria (13 listed)
- Pregnant or lactating
- Already using a split regimen of combination CSII and basal insulin injection
- Active diabetic retinopathy (proliferated diabetic retinopathy, or vitreous hemorrhage in past 6 months) that could potentially be worsened by the exercise protocol
- Any evidence of unstable cardiovascular disease, disorders or abnormalities as per physician's discretion
- Currently following a very low calorie or other weight-loss diet which may impact glucose control and mask the primary and secondary outcome measures
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 |
|---|---|---|
| Insulin DegludecAlso: Tresiba50% of the patient's daily basal insulin dose delivered through once daily insulin degludec injected in the morning; 50% of the basal insulin to be delivered through previously established CSII | Drug | Untethered CSII |
Primary outcome
Time in range within 6 hours
Time frame: 6 hours
Percentage of time with CGM glucose between 4.0 - 10.0 mmol/L within 6 hours after the start of high-intensity or moderate-intensity, in-clinic exercise
11 secondary outcomes
Change in glucose within 60 mins after high-intensity exercise starts
Time frame: 60 mins
Change in glucose within 120 mins after moderate-intensity exercise starts
Time frame: 120 mins
Time spent in hypoglycemia 24 hours after exercise
Time frame: 24 hours
Time in range 24 hours after exercise
Time frame: 24 hours
Time spent in hyperglycemia 24 hours after exercise
Time frame: 24 hours
Time in range in the last 4 weeks of each study phase
Time frame: 4 weeks
Frequency of hypoglycemia 24 hours after exercise
Time frame: 24 hours
Frequency of hypoglycemia in the last 4 weeks of each study phase
Time frame: 4 weeks
Change in Diabetes Medication Satisfaction (DiabMedSat) Score
Time frame: 11 weeks
Change in Hypoglycemia Fear Score
Time frame: 11 weeks
Change in TRIM-D Score
Time frame: 11 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Background: PubMed 15220227Doyle EA, Weinzimer SA, Steffen AT, Ahern JA, Vincent M, Tamborlane WV. A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care. 2004 Jul;27(7):1554-8. doi: 10.2337/diacare.27.7.1554.
- Background: PubMed 26901138Binek A, Rembierz-Knoll A, Polanska J, Jarosz-Chobot P. Reasons for the discontinuation of therapy of personal insulin pump in children with type 1 diabetes. Pediatr Endocrinol Diabetes Metab. 2016 Feb 18;21(2):65-9. doi: 10.18544/PEDM-21.02.0026.
- Background: PubMed 27595711Wong JC, Boyle C, DiMeglio LA, Mastrandrea LD, Abel KL, Cengiz E, Cemeroglu PA, Aleppo G, Largay JF, Foster NC, Beck RW, Adi S; T1D Exchange Clinic Network. Evaluation of Pump Discontinuation and Associated Factors in the T1D Exchange Clinic Registry. J Diabetes Sci Technol. 2017 Mar;11(2):224-232. doi: 10.1177/1932296816663963. Epub 2016 Sep 25.
- Background: PubMed 25825689Benbenek-Klupa T, Matejko B, Klupa T. Metabolic control in type 1 diabetes patients practicing combat sports: at least two-year follow-up study. Springerplus. 2015 Mar 17;4:133. doi: 10.1186/s40064-015-0919-5. eCollection 2015.
- Background: PubMed 19474521Delvecchio M, Zecchino C, Salzano G, Faienza MF, Cavallo L, De Luca F, Lombardo F. Effects of moderate-severe exercise on blood glucose in Type 1 diabetic adolescents treated with insulin pump or glargine insulin. J Endocrinol Invest. 2009 Jun;32(6):519-24. doi: 10.1007/BF03346499.
- Background: PubMed 25492557Yardley JE, Zaharieva DP, Jarvis C, Riddell MC. The "ups" and "downs" of a bike race in people with type 1 diabetes: dramatic differences in strategies and blood glucose responses in the Paris-to-Ancaster Spring Classic. Can J Diabetes. 2015 Apr;39(2):105-10. doi: 10.1016/j.jcjd.2014.09.003. Epub 2014 Dec 6.
- Background: PubMed 28126459Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millan IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24.
- Derived from this study: PubMed 32445738Aronson R, Li A, Brown RE, McGaugh S, Riddell MC. Flexible insulin therapy with a hybrid regimen of insulin degludec and continuous subcutaneous insulin infusion with pump suspension before exercise in physically active adults with type 1 diabetes (FIT Untethered): a single-centre, open-label, proof-of-concept, randomised crossover trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):511-523. doi: 10.1016/S2213-8587(20)30114-5.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin Degludec in people with Type 1 Diabetes Mellitus, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronnie Aronson, MD (416-645-2929, aronsonresearch@lmc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range within 6 hours (time frame: 6 hours). 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 NCT03838783, which also lists 8 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 12 Feb 2019.