ClinicalTrials.gg
RecruitingNCT06686329Missed DoseUpdated Mar 12, 2026

Physical Activity to Prevent and Treat Hyperglycemia From a Mistimed Bolus Insulin Dose

An interventional study of Control (CON) and Missed Dose (MISS) in Type 1 Diabetes Mellitus, sponsored by Jane Yardley. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-03-12.

Sponsored by Jane Yardley · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 24 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 318 studies in Diabetes Mellitus, Type 1 with a site in Canada — 48 open to participants now, 61 under way, 15 of them phase 3. Diabetes Mellitus, Type 1 · Canada.

Planned enrollment
166th of 274
30 · median 45
Started
2025
with 15 others
No phase
98 of 318
20 open now
Primary completion
2026-04
later than 11 of 60 live
Registered
293rd of 318
by date

Among the 318 studies in Diabetes Mellitus, Type 1 with a site in Canada, this one is the 166th largest by planned enrollment of the 274 interventional ones, is one of 16 that started in 2025, is one of 98 with no phase, reaches primary completion later than 11 of the 60 other live ones, and was the 293rd registered.

By phase

318 studies; the count open now beside each. This study's row is marked.

No phasethis study98 · 20 open
Phase 362 · 7 open
Phase 259 · 5 open
Observational44 · 9 open
Phase 123 · 2 open
Phase 1/212 · 1 open
Phase 412 · 0 open
Phase 2/38 · 4 open

By the year they started

First in 1983; this study’s year is marked. 16 started in 2025.

Size and results

Median enrollment 45 across the 274 interventional studies, 205 across the 44 observational. Of the 230 that completed or were terminated, 73 (32%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 318 studies in Diabetes Mellitus, Type 1 with a site in Canada, or all of them as a file.
02

Study summary

People living with type 1 diabetes (PwT1D) are recommended to administer insulin 10-15 minutes before meal consumption (pre-bolus), to account for the delay in the glucose lowering action associated with subcutaneously administered insulin. Due to the demands of day-to-day life, pre-bolusing is not always possible or may be forgotten. With continuous glucose monitors (CGMs), PwT1D may be alerted to this missed insulin dose by a CGM alert, including rapidly rising glucose (change >2.5mmol/L/15min) or hyperglycemia (>10.0 mmol/L), and deliver a mistimed (post-prandial) dose in response to CGM alert.

This study was designed to determine the effect of combining a post-prandial/mistimed insulin dose with 15 minutes of brisk walking. It is expected that walking will help to minimize or prevent hyperglycemia after a mistimed bolus insulin dose, as well as blunt the rise in glucose following a mistimed insulin dose.

Read the detailed description

While important for managing glucose concentration, achieving consistent pre-prandial dosing is difficult. A recent study of 3,945 adults living with T1D found an average of six missed bolus doses during a 14-day period, with each missed dose being associated with -1.7% (-1.8, -1.6) less time in target range. An increase of 5% in time in range is a clinically significant improvement. The frequency of missed boluses reported by adolescents and young adults is especially high with 33% of those aged 13 - 18 years (n=1513), and 43% of those aged 18 - 26 years (n=1160) reporting more than one mistimed insulin delivery per week in a USA clinic registry cohort. Missing or mistiming two bolus doses weekly can raise HbA1c, a 3-month proxy of average glucose, by 0.5%. A 1% increase in HbA1c is associated with a 2.2- and 1.8-fold increase in the risk of developing nephropathy and retinopathy, respectively.

This large increase in HbA1c from just two missed or mistimed doses weekly is likely due to the subsequent duration and severity of hyperglycemia. Upon recognition of a mistimed insulin dose, blood glucose (BG) levels may already be rising rapidly or in a hyperglycemic range (>10.0 mmol/L) causing the duration of the resulting glucose excursion to be prolonged. Common explanations for missed doses include forgetting, disruption to usual routine (ex. travelling), dosing interfered with performing activities, hypoglycemia avoidance, injection pain, and embarrassment.

To meet the increased energy demands of PA, glucose uptake in contracting skeletal muscle increases through mechanisms which are dependent and independent of insulin. In the context of T1D this increased uptake can be problematic for maintaining normoglycemia because insulin-mediated glucose uptake does not decrease, as it does in people without diabetes. Additionally, PA decreases blood flow to the gut and slows gastric emptying which delays the entry of glucose into circulation following the consumption of food, and blunts the rise in blood glucose following food consumption in people without diabetes. While the glucose lowering effects of PA are generally problematic for people living with T1D due to an increased risk of hypoglycemia, PA could be useful to reduce glucose concentration when it is increasing rapidly, such as after a mistimed insulin dose. In the context of a mistimed insulin dose, PA may be beneficial as it: 1) begins to lower blood glucose concentration immediately independently of insulin, 2) increases sensitivity to insulin, and 3) delays glucose entry into circulation. Therefore, PA may be a useful strategy to lower blood glucose more quickly when combined with an insulin dose following recognition of a mistimed dose.

One study has investigated the effect of postprandial walking on the glucose concentration of people living with T1D and found that, compared to remaining sedentary after a meal, 15 minutes of brisk walking lead to a 36.2% and 47.2% reduction in peak glucose and incremental area under the curve (iAUC) of capillary glucose during the 2 hours after a meal, respectively. The exact timing of insulin dosage in the aforementioned study is unclear but occurred sometime within 10 minutes of the onset of meal consumption.

Pretest measures: Interested participants will be invited to the IRCM. Participants will be asked questions related to diabetes management, PA levels, and medication. Resting blood pressure and heart rate will also be measured. Where participants are eligible, anthropometric characteristics will be measured using standard protocols. Estimated A1c will be obtained with the last 30-days of CGM data. Participants will be asked to answer to some questionnaires about their barriers to physical activity, diabetes distress and socio-demographic characteristics. Those who meet all eligibility criteria and complete informed consent forms will be asked to test the standardized meal in order to determine the insulin bolus that will then be used during the three intervention visits. Participants will also perform an estimated maximal aerobic capacity test on a treadmill.

Testing sessions: Participants will be asked to arrive at the lab between 11am and 2pm on three occasions. This study will consist of three separate testing sessions where participants consume a standardized meal. Participants will administer their mealtime insulin bolus under three conditions: i) 15 minutes prior to eating (CON), ii) post-prandially when alerted to rapidly rising glucose (increase of 0.2 mmol/L/min) or hyperglycemia (> 10.0 mmol/L) by CGM (MISS), as well as iii) the same conditions as MISS but with a 15-minute walk performed immediately after insulin administration (MISS+EX).

Capillary blood glucose will be assessed every 30 minutes during the intervention visits. Participants will remain in the testing facility for 3 hours after the meal, provided that their CGM glucose has returned to target range (4.0-10.0 mmol/L). During the three hours after the meal, participants will not consume additional food (excluding hypoglycemia treatment), engage in physical activity, or administer additional correction insulin. Participants will be asked to match their daily food and insulin intake as closely as possible from one testing session to the next for the day before and during the morning before each intervention visit. Participants will be provided with log sheets to assist in this task and will also be asked to avoid strenuous exercise and alcohol intake the day before and the day of each intervention visit.

03

Conditions studied

  • Type 1 Diabetes Mellitus

Keywords

  • Type 1 diabetes
  • Exercise
  • Hyperglycemia
04

Who can participate

Ages eligible
18 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-24 years
  • Type 1 diabetes diagnostic for at least two years
  • Estimated or glucose management indicator obtained from the past 30 days of CGM data of \< 9.9%
  • Use a Dexcom G7 CGM in routine care

Exclusion criteria

Exclusion Criteria:

  • Changes in insulin management strategy within the past 2 months
  • Diagnosis of gastroparesis
  • Having a condition that could render exercise harmful
  • Intolerance to gluten and lactose
  • Having significant renal disease (e.g., eGRF \< 30 ml/min)
  • Inability to provide due to cognitive deficit
  • Currently taking other medications (other than insulin) that may alter glucose metabolism (e.g., non-insulin antihyperglycemic drugs such as sglt2-inhibitors, ), unless dosages thereof have been stable for more than three months
  • For women, being pregnant or breastfeeding
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    All participants

    All participants will be in a single arm that undergoes three separate interventions. These interventions will include three different mealtime insulin administration: i) 15 minutes prior to eating, ii) post-prandially when alerted to rapidly rising glucose (increase of 0.2 mmol/L/min) or hyperglycemia (\> 10.0 mmol/L) by CGM, and iii) the same conditions as ii) but with a 15-minute walk performed immediately after insulin administration.

    Behavioral: Control (CON) · Behavioral: Missed Dose (MISS) · Behavioral: Missed Dose + 15min walk (MISS+EX)

Interventions

  • BehavioralControl (CON)

    Standardized meal with insulin administered 15 minutes before eating

  • BehavioralMissed Dose (MISS)

    Standardized meal with insulin administered post-prandially when alerted to rapidly rising glucose (increase of 0.2 mmol/L/min) or hyperglycemia (\> 10.0 mmol/L) by CGM

  • BehavioralMissed Dose + 15min walk (MISS+EX)

    Standardized meal with insulin administered post-prandially when alerted to rapidly rising glucose (increase of 0.2 mmol/L/min) or hyperglycemia (\> 10.0 mmol/L) by CGM with a 15-minute walk performed immediately after insulin administration

06

What researchers measure

Primary outcomes

  1. Mean glucose

    Mean glucose, adjusted for baseline glucose, from the start of the meal until 3 hours after the meal

    Time frame: From 0 minute to 180 minutes

Secondary outcomes

  1. Automated insulin

    Amount of insulin delivered by automated treatment systems during the three hours after the meal

    Time frame: From 0 minute to 180 minutes

  2. Time in range

    Time in range (4.0-10.0 mmol/L) over time periods of 6 hours, 12 hours, overnight (midnight-6am) and 24 hours after the meal to investigate any delayed or prolonged effects.

    Time frame: Up to 6 hours after the meal, up to 12 hours after the meal, overnight (midnight-6am) and up to 24 hours after the meal

  3. Time below range

    Time below range (\<4.0 mmol/L) over time periods of 6 hours, 12 hours, overnight (midnight-6am) and 24 hours after the meal to investigate any delayed or prolonged effects.

    Time frame: Up to 6 hours after the meal, up to 12 hours after the meal, overnight (midnight-6am) and up to 24 hours after the meal

  4. Time above range

    Time above range (\>10.0 mmol/L) over time periods of 6 hours, 12 hours, overnight (midnight-6am) and 24 hours after the meal to investigate any delayed or prolonged effects.

    Time frame: Up to 6 hours after the meal, up to 12 hours after the meal, overnight (midnight-6am) and up to 24 hours after the meal

  5. Area under the curve

    Area under the curve (AUC) over time periods of 6 hours, 12 hours, overnight (midnight-6am) and 24 hours after the meal to investigate any delayed or prolonged effects.

    Time frame: Up to 6 hours after the meal, up to 12 hours after the meal, overnight (midnight-6am) and up to 24 hours after the meal

  6. Coefficient of variation

    Coefficient of variation (CV%) over time periods of 6 hours, 12 hours, overnight (midnight-6am) and 24 hours after the meal to investigate any delayed or prolonged effects.

    Time frame: Up to 6 hours after the meal, up to 12 hours after the meal, overnight (midnight-6am) and up to 24 hours after the meal

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Apr 2026, 13 months after the start.

Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 13 months is below that.

Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2024
First posted
Nov 13, 2024
StartActual
Mar 17, 2025
Primary completionEst.
Apr 30, 2026
CompletionEst.
Sep 30, 2026
Last update
Mar 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06686329
Lead sponsor
Jane Yardley
Collaborators
Diabetes Québec
Responsible party
Jane Yardley (Research unit director, PhD, Institut de Recherches Cliniques de Montreal) — Sponsor-investigator
First posted
Nov 13, 2024
Start date
Mar 17, 2025
Primary completion
Apr 30, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Mar 12, 2026

Study contacts

Corinne Suppère, MSc
Contact
corinne.suppere@ircm.qc.ca
514-987-5597
Jane Yardley, PhD
Contact
jane.yardley@ircm.qc.ca
514-987-5568

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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