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
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.
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 30 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →48 of the 318 studies in Diabetes Mellitus, Type 1 with a site in Canada are open now, in 12 countries. Each count lists the studies.
Of the 411 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 257 (63%) stop at 75 or younger; 184 take children under 18; 64 take healthy volunteers.
This study: 18 Years to 24 Years · all sexes · no healthy volunteers.
The full table on the hub →318 studies; the count open now beside each. This study's row is marked.
First in 1983; this study’s year is marked. 16 started in 2025.
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.
97 of 318 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Jane Yardley as lead sponsor.
Jane Yardley has 1 study filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
25 of the studies in Diabetes Mellitus, Type 1 with a site in Canada that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06962280Phase 3Eli Lilly and CompanyA Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight | 2026-11 |
| NCT06894784Phase 3McGill University Health Centre/Research Institute of the McGill University Health CentreA Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes | 2027-01 |
| NCT06387199Phase 3McGill University Health Centre/Research Institute of the McGill University Health CentreAlleviating Carbohydrate Counting for Patients with Type-1 Diabetes Using a Closed Loop System with Weekly Subcutaneous Semaglutide | 2027-01 |
| NCT07076199Phase 3Novo Nordisk A/SA Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes | 2027-01-25 |
| NCT04598893Provention Bio, a Sanofi CompanyRecent-Onset Type 1 Diabetes Extension Study Evaluating the Long-Term Safety of Teplizumab (PROTECT Extension) | 2026-11 |
Among the 318 studies in Diabetes Mellitus, Type 1 with a site in Canada, from their registry updates:
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.
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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Standardized meal with insulin administered 15 minutes before eating
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
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
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
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
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
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.
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