AzTrials
AzTrials

Diabetes Mellitus, Type 1Phase 4FITNCT03057470

Optimal Insulin Correction Factor in Post- High Intensity Exercise Hyperglycemia in Adults With Type 1 Diabetes (FIT)

A Phase 4 study testing 50% bolus insulin correction, 100% bolus insulin correction and 150% bolus insulin correction in people with Diabetes Mellitus, Type 1, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The overall objective of this study is to investigate the glycemic response of a 0%, 50%, 100% and 150% bolus insulin correction (based on personal insulin correction factor) of post-exercise hyperglycemia in physically active adults with type 1 diabetes (T1D) using multiple daily injections (MDI) in a controlled, but… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
50% bolus insulin correction, 100% bolus insulin correction and 150% bolus insulin correction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteCanada
Study dates
May 2016to Mar 2017
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

  • Male or female
  • Clinical diagnosis of presumed autoimmune T1D
  • Age 18-55 years, inclusive
  • Duration of T1D ≥ 6 months
  • Using MDI therapy for at least 6 months
  • Fasting C-peptide value of < 0.7 ng/mL (0.23 nmol/L) at screening visit
Show all 13Show fewer
  • Patient must be willing to undergo an 8-week run-in phase prior to the study period where they will be required to use MDI therapy at least 4 times per day, and switch from their usual basal insulin to insulin glargine U300
  • Exercise regularly: i.e. ≥ 30 minutes of moderate or vigorous aerobic activity ≥ 3 times/week for a minimum of 90 minutes weekly
  • VO2peak ≥32 ml/kg/min for females and ≥ 35 ml/kg/min for males
  • HbA1c between 6.0-9.0% inclusive at screening visit.
  • Insulin total daily dose (TDD) ≥ 30 U/day
  • In good general health with no known conditions that could influence the outcome of the trial, and in the judgement 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

Who cannot join

  • Pregnant or lactating
  • Active diabetic retinopathy (proliferative diabetic retinopathy, or vitreous haemorrhage 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
  • Known hypoglycemia unawareness
Show all 12Show fewer
  • Use of acetaminophen (Tylenol) during the run-in phase or study period
  • Medications other than insulin that might impact outcome measures:
  • Beta blockers
  • Agents that affect hepatic glucose production such as beta adrenergic agonists and antagonists, xanthine derivatives
  • Pramlintide
  • Any non-insulin diabetes therapy

Trial locations and contacts

1 site in 1 country.

Ronnie Aronson, MD contact

416-645-2929

aronsonresearch@LMC.ca

Saeideh Mayanloo, BSc contact

416-645-2929 ext. 9330

saeideh.mayanloo@LMC.ca

Canada1 site, 1 recruiting

  • LMC Bayview

    Toronto, Ontario

    Ronnie Aronson, MD, 416-645-2929, torontoresearch@lmc.ca

    Recruiting

Other trials in Canada

About this study

Official title: Optimal Insulin Correction Factor in Post- High Intensity Exercise Hyperglycemia in Adults With Type 1 Diabetes: The FIT Study

The overall objective of this study is to investigate the glycemic response of a 0%, 50%, 100% and 150% bolus insulin correction (based on personal insulin correction factor) of post-exercise hyperglycemia in physically active adults with type 1 diabetes (T1D) using multiple daily injections (MDI) in a controlled, but clinically representative, experimental setting.

Read the detailed description

FIT is an open-label, repeated measures cross-over study. The overall objective of this study is to investigate the glycemic response of a 0%, 50%, 100% and 150% bolus insulin correction (based on personal insulin correction factor) of post-exercise hyperglycemia in physically active adults with type 1 diabetes (T1D) using multiple daily injections (MDI) in a controlled, but clinically representative, experimental setting. Following a 2 week screening phase, patients will enter an 8 week transition to insulin glargine U300 (Toujeo®) if on another basal insulin, in order to optimize their insulin dose and determine their individual insulin correction factor. The final phase of the study is the intervention phase, which consists of 4 separate visits. At each visit, the patient will perform 15 minutes of high intensity exercise in the morning. If they become hyperglycemic following exercise (blood glucose >8.0 mmol/L), they will receive one of four insulin correction doses (0% 50%, 100%, or 150% of their usual correction factor) in a randomized order. They will be monitored in the clinical pharmacology unit by study staff for the rest of the day and overnight. The patient will wear a continuous glucose monitor (CGM) during each intervention visit. The primary outcome of the study is the greatest net reduction in plasma glucose (YSI) following a 50%, 100% and 150% bolus insulin correction of post-exercise hyperglycemia, compared to no bolus insulin correction. Key secondary outcomes include the mean time spent in post-exercise hyperglycemia (>8.0 mmol/L), post-exercise euglycemia (4.0-8.0 mmol/L) and post-exercise hypoglycaemia (≤ 3.9 mmol/L) within 180 minutes and 24 hours following bolus insulin correction.

Being tested
50% bolus insulin correction, 100% bolus insulin correction, 150% bolus insulin correction, 0% bolus insulin correction
Keywords
Diabetes, Exercise, Insulin
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Motor Activity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 50% bolus insulin correctionDrug

    Patients will receive 50% of their usual bolus insulin correction for post-exercise hyperglycemia

  • 100% bolus insulin correctionDrug

    Patients will receive 100% of their usual bolus insulin correction for post-exercise hyperglycemia

  • 150% bolus insulin correctionDrug

    Patients will receive 150% of their usual bolus insulin correction for post-exercise hyperglycemia

  • 0% bolus insulin correctionOther

    Patients will receive no bolus insulin correction for post-exercise hyperglycemia

Study groups in NCT03057470
Study groupRoleWhat they receive
0% Bolus Insulin CorrectionActive comparator0% Bolus Insulin Correction
Receives: Other: 0% bolus insulin correction
50% Bolus Insulin CorrectionActive comparator50% Bolus Insulin Correction
Receives: Drug: 50% bolus insulin correction
100% Bolus Insulin CorrectionActive comparator100% Bolus Insulin Correction
Receives: Drug: 100% bolus insulin correction
150% Bolus Insulin CorrectionActive comparator150% Bolus Insulin Correction
Receives: Drug: 150% bolus insulin correction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction In Plasma Glucose (YSI)

    Measured: 147 days

Secondary outcomes (1)

  1. Investigate Glycemic Response of a 0%, 50%, 100% and 150% Bolus Insulin Correction of Post-exercise Hyperglycemia Compared to no Bolus Insulin Correction

    Measured: 147 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2017
  2. Study startMay 2016
  3. Primary completionMar 2017 (estimated)
  4. Study completionMar 2017 (estimated)

Resources

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
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03057470
Sponsor's protocol ID
FIT
Acronym
FIT
Status last verified
Feb 2017
First submitted
23 Dec 2016
Last updated
20 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No: Only overall study data will be shared

Publications

  • 1. Robertson K, Adolfsson P, Scheiner G, Hanas R, Riddell M. Exercise in children and adolescents with diabetes. Pediatric diabetes. 2009;10(Journal Article):154. 2. Wasserman DH, Zinman B. Exercise in individuals with IDDM. Diabetes Care. 1994;17(8):924-937. 3. Galassetti P, Riddell MC. Exercise and type 1 diabetes (T1DM). Compr Physiol. 2013;3(3):1309-1336. 4. Zaharieva DP, Riddell MC. Prevention of exercise-associated dysglycemia: a case study-based approach. Diabetes Spectr. 2015;28(1):55-62. 5. Pivovarov JA, Taplin CE, Riddell MC. Current perspectives on physical activity and exercise for youth with diabetes. Pediatr Diabetes. 2015. 6. Marliss EB, Vranic M. Intense exercise has unique effects on both insulin release and its roles in glucoregulation: implications for diabetes. Diabetes. 2002;51 Suppl 1:S271-283. 7. Fahey AJ, Paramalingam N, Davey RJ, Davis EA, Jones TW, Fournier PA. The effect of a short sprint on postexercise whole-body glucose production and utilization rates in individuals with type 1 diabetes mellitus. J Clin Endocrinol Metab. 2012;97(11):4193-4200. 8. Benbenek-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;4:133. 9. Iscoe KE, Riddell MC. Continuous moderate-intensity exercise with or without intermittent high-intensity work: effects on acute and late glycaemia in athletes with Type 1 diabetes mellitus. Diabetic Med. 2011;28(7):824-832. 10. Graveling AJ, Frier BM. Risks of marathon running and hypoglycaemia in Type 1 diabetes. Diabet Med. 2010;27(5):585-588. 11. Tanenberg RJ, Newton CA, Drake AJ. Confirmation of hypoglycemia in the

  • Potashner D, Brown RE, Li A, Riddell MC, Aronson R. Paradoxical Rise in Hypoglycemia Symptoms With Development of Hyperglycemia During High-Intensity Interval Training in Type 1 Diabetes. Diabetes Care. 2019 Oct;42(10):2011-2014. doi: 10.2337/dc19-0609. Epub 2019 Aug 7.

    PubMed 31391201

  • Aronson R, Brown RE, Li A, Riddell MC. Optimal Insulin Correction Factor in Post-High-Intensity Exercise Hyperglycemia in Adults With Type 1 Diabetes: The FIT Study. Diabetes Care. 2019 Jan;42(1):10-16. doi: 10.2337/dc18-1475. Epub 2018 Nov 19.

    PubMed 30455336

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 50% bolus insulin correction, 100% bolus insulin correction and 150% bolus insulin correction in people with Diabetes Mellitus, Type 1, 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 13 inclusion and 12 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 20 Feb 2017. 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?

Reduction In Plasma Glucose (YSI) (time frame: 147 days). 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 NCT03057470, which also lists 3 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 20 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in