An interventional study of DailyDose in Type 1 Diabetes (T1D), sponsored by Oregon Health and Science University. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment
Among 20 studies in Diabetes Mellitus, Type 1 by Oregon Health and Science University — 5 open to participants now, 5 under way, none of them phase 3. Diabetes Mellitus, Type 1 · Oregon Health and Science University.
Among the 20 studies in Diabetes Mellitus, Type 1 by Oregon Health and Science University, this one has the largest planned enrollment of the 18 interventional ones that give a count, is one of 3 that started in 2026, is one of 16 with no phase, and was the 18th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →5 of the 20 studies in Diabetes Mellitus, Type 1 by Oregon Health and Science University are open now, in 1 country. Recruiting first, the newest first:
Oregon Health and Science University · Sites in United States
Ages 18–100
Oregon Health and Science University
Ages 18–70
Oregon Health and Science University · Sites in United States
Ages 18–75
Oregon Health and Science University · Sites in United States
Ages 6–18
By country, each count listing its 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 and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 99 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 26 across the 18 interventional studies, 50 across the 2 observational. Of the 15 that completed or were terminated, 12 (80%) have results posted.
This tab as a report to print or save as PDF → With an account.
Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
2 of the studies in Diabetes Mellitus, Type 1 by Oregon Health and Science University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07914621Oregon Health and Science UniversityOutpatient Pramlintide Study | 2027-01-31 |
| NCT07282639Oregon Health and Science UniversityApp-Based Certified Diabetes Education Therapy (AB-CDE) | 2027-07-15 |
Among the 20 studies in Diabetes Mellitus, Type 1 by Oregon Health and Science University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to learn more about a smartphone application (app) called DailyDose, an investigational decision support tool that may help in managing your diabetes. DailyDose tracks your continuous glucose monitoring (CGM) data, insulin use, and exercise, and uses this information to provide personalized recommendations for insulin dosing and carbohydrate intake during exercise or low blood sugar events. We want to find out if DailyDose can help lower blood sugar levels as measured by the hemoglobin A1c (HbA1c) test.
Participants will be on study for 38 weeks (2-week run-in period and 36 weeks of intervention). Participants will begin the study with a training visit on the Dexcom G6 CGM system, the insulin dose capture system, and the Data-logging Mode of DailyDose. Participants will be provided with Novalog InPens for use with the insulin dose capture system. Participants will also receive an iPhone and Apple smart watch for acquiring sleep metrics and exercise data. Participants will use these devices during the next 14 days at home (2-week run-in). At the end of the run-in, participants will start the intervention. They will be trained at Visit 3 on using the DailyDose system. Participants will then use the DailyDose system for 12 weeks. Sensor glucose, exercise, insulin and meal data will be collected during the DailyDose portion of the study in order to produce recommendations for insulin dosing. Participants will wear the Dexcom G6 for the entire study. Insulin data will be collected using the insulin dose capture system (InPens). Participants will be instructed to use the bolus calculator within the DailyDose app. Participants will be asked to complete a 30-minute aerobic exercise video at home once per week starting with the first 12-week period. After 12 weeks, time in range (70-180 mg/dL, TIR) and time in hypoglycemia (\<70 mg/dL) will be assessed from the prior 4 weeks based on the Dexcom G6. Participants that have TIR ≥ 60% and time in hypoglycemia \<4% will continue with use of DailyDose. Those that have TIR \< 60% and/or time in hypoglycemia ≥ 4% will receive DSMES and, if recommended, behavioral health based on the T1-Diabetes Distress Assessment System (T1-DDAS) for the next 12 weeks. Additionally, if the DSMES provider feels the participant would benefit from behavioral health intervention, they can refer the participant for this even if T1-DDAS scores do not meet the cut off. All participants will then be followed for a final 12-week period using DailyDose alone to assess sustainability of any improvements in glycemic outcomes.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AB-CDE intervention using DailyDose, study CGM, and CDE and BH counselling if indicated
Device: DailyDose
Usual care including MDI insulin therapy with study CGM and DailyDose in Data-logging Mode.
Our team has developed a smartphone-based application, DailyDose Decision Support Tool (DailyDose), that combines continuous glucose monitoring data and insulin data to provide decision support for people living with T1D taking MDI. DailyDose is an iPhone application that is designed to support this population by 1) allowing for bolus calculation based on inputs including carbohydrate intake, CGM value and trend, and exercise information, 2) providing recommendations for carbohydrate intake based on exercise type, intensity, and duration, and 3) providing weekly recommendations for adjustments in insulin doses at specific times of day, including basal insulin dose, carbohydrate ratios or fixed mealtime doses, and correction factors .
Change in hemoglobin A1c (HbA1c) from baseline to 24 weeks
Hemoglobin A1c will be processed by a central lab. Lower values generally indicate better glucose control.
Time frame: Enrollment and 24 weeks after randomization
Change in hemoglobin A1c (HbA1c) from baseline to 36 weeks
Hemoglobin A1c will be processed by a central lab.
Time frame: Enrollment and 36 weeks
Change in percent of time in range (70-180 mg/dL) from baseline to 24 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 24 after randomization compared with baseline
Change in percent of time in range (70-180 mg/dL) from baseline to 36 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 36 after randomization compared with baseline
Change in percent of time in tight range (70-140 mg/dL) from baseline to 24 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 24 after randomization compared with baseline
Change in percent of time in tight range (70-140 mg/dL) from baseline to 36 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 36 after randomization compared with baseline
Change in percent of time in low glucose range (<70 mg/dL) from baseline to 24 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 24 after randomization compared with baseline
Change in percent of time in low glucose range (<70 mg/dL) from baseline to 36 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 36 after randomization compared with baseline
Change in percent of time in very low glucose range (<54 mg/dL) from baseline to 24 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 24 after randomization compared with baseline
Change in percent of time in very low glucose range (<54 mg/dL) from baseline to 36 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 36 after randomization compared with baseline
Change in percent of time in high glucose range (>180 mg/dL) from baseline to 24 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 24 after randomization compared with baseline
Change in percent of time in high glucose range (>180 mg/dL) from baseline to 36 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 36 after randomization compared with baseline
Change in percent of time in extreme high glucose range (>250 mg/dL) from baseline to 24 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 24 after randomization compared with baseline
Change in percent of time in extreme high glucose range (>250 mg/dL) from baseline to 36 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 36 after randomization compared with baseline
Change in mean blood glucose from baseline to 24 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The average of values collected during the two weeks before a study time point will be treated as representing mean glucose at that study time point.
Time frame: Week 24 after randomization compared with baseline
Change in mean blood glucose from baseline to 36 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The average of values collected during the two weeks before a study time point will be treated as representing mean glucose at that study time point.
Time frame: Week 36 after randomization compared with baseline
Change in coefficient of variation of blood glucose from baseline to 24 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The coefficient of variation (CV) of CGM values is calculated as SD / mean \* 100, where SD = standard deviation. The two weeks before a study time point will be used to represent that study time point.
Time frame: Week 24 after randomization compared with baseline
Change in coefficient of variation of blood glucose from baseline to 36 weeks after randomization
Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The coefficient of variation (CV) of CGM values is calculated as SD / mean \* 100, where SD = standard deviation. The two weeks before a study time point will be used to represent that study time point.
Time frame: Week 36 after randomization compared with baseline
Change in Low Blood Glucose Index (LBGI) from baseline to 24 weeks after randomization
The Low Blood Glucose Index (LBGI) is designed to reflect the risk of hypoglycemia and increases with the extent and frequency of hypoglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)\^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rl(BG) = 22.7 \* f(BG)\^2 if f(BG) ≤ 0 and rl(BG) = 0 otherwise, and finally, by taking the average of the calculated rl(BG) values over all of the glucose readings measured in mg/dL.
Time frame: Week 24 after randomization compared with baseline
Change in Low Blood Glucose Index (LBGI) from baseline to 36 weeks after randomization
The Low Blood Glucose Index (LBGI) is designed to reflect the risk of hypoglycemia and increases with the extent and frequency of hypoglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)\^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rl(BG) = 22.7 \* f(BG)\^2 if f(BG) ≤ 0 and rl(BG) = 0 otherwise, and finally, by taking the average of the calculated rl(BG) values over all of the glucose readings measured in mg/dL.
Time frame: Week 36 after randomization compared with baseline
Change in High Blood Glucose Index (HBGI) from baseline to 24 weeks after randomization
The High Blood Glucose Index (HBGI) is designed to reflect the risk of hyperglycemia and increases with the extent and frequency of hyperglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)\^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rh(BG) = 22.7 \* f(BG)\^2 if f(BG) \> 0 and rh(BG) = 0 otherwise, and finally, by taking the average of the calculated rh(BG) values over all of the glucose readings measured in mg/dL.
Time frame: Week 24 after randomization compared with baseline
Change in High Blood Glucose Index (HBGI) from baseline to 36 weeks after randomization
The High Blood Glucose Index (HBGI) is designed to reflect the risk of hyperglycemia and increases with the extent and frequency of hyperglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)\^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rh(BG) = 22.7 \* f(BG)\^2 if f(BG) \> 0 and rh(BG) = 0 otherwise, and finally, by taking the average of the calculated rh(BG) values over all of the glucose readings measured in mg/dL.
Time frame: Week 36 after randomization compared with baseline
Change in T1-DDAS Core Score from baseline to 24 weeks after randomization
The Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score is the average of 8 items on a scale from 1 to 5, where 1 is low distress and 5 is high distress associated with having type 1 diabetes.
Time frame: Week 24 after randomization compared with baseline
Change in T1-DDAS Core Score from baseline to 36 weeks after randomization
The Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score is the average of 8 items on a scale from 1 to 5, where 1 is low distress and 5 is high distress associated with having type 1 diabetes.
Time frame: Week 36 after randomization compared with baseline
Change in T1-DDAS Management Difficulties Source Score from baseline to 24 weeks after randomization
The Type 1 Diabetes Distress Assessment System (T1-DDAS) Management Difficulties Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to management of type 1 diabetes.
Time frame: Week 24 after randomization compared with baseline
Change in T1-DDAS Management Difficulties Source Score from baseline to 36 weeks after randomization
The Type 1 Diabetes Distress Assessment System (T1-DDAS) Management Difficulties Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to management of type 1 diabetes.
Time frame: Week 36 after randomization compared with baseline
Change in T1-DDAS Hypoglycemia Concerns Source Score from baseline to 24 weeks after randomization
The Type 1 Diabetes Distress Assessment System (T1-DDAS) Hypoglycemia Concerns Source Score is the average of 2 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to hypoglycemia.
Time frame: Week 24 after randomization compared with baseline
Change in T1-DDAS Hypoglycemia Concerns Source Score from baseline to 36 weeks after randomization
The Type 1 Diabetes Distress Assessment System (T1-DDAS) Hypoglycemia Concerns Source Score is the average of 2 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to hypoglycemia.
Time frame: Week 36 after randomization compared with baseline
Change in T1-DDAS Technology Challenges Source Score from baseline to 24 weeks after randomization
The Type 1 Diabetes Distress Assessment System (T1-DDAS) Technology Challenges Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to using devices to manage type 1 diabetes.
Time frame: Week 24 after randomization compared with baseline
Change in T1-DDAS Technology Challenges Source Score from baseline to 36 weeks after randomization
The Type 1 Diabetes Distress Assessment System (T1-DDAS) Technology Challenges Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to using devices to manage type 1 diabetes.
Time frame: Week 36 after randomization compared with baseline
Change in mean number of low glucose events / week from baseline to 24 weeks after randomization
A single low glucose event is defined to start when the CGM drops below 70 mg/dL for at least three measurements and ends when the CGM rises above 69 mg/dL for at least three measurements. The two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 24 after randomization compared with baseline
Change in mean number of low glucose events / week from baseline to 36 weeks after randomization
A single low glucose event is defined to start when the CGM drops below 70 mg/dL for at least three measurements and ends when the CGM rises above 69 mg/dL for at least three measurements. The two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Time frame: Week 36 after randomization compared with baseline
Change in total daily dose of insulin (units) from baseline to 24 weeks
Insulin use will be tracked using bluetooth-enabled insulin pens. The two weeks before a study time point will be treated as representing that study time point.
Time frame: Week 24 after randomization compared with baseline
Change in total daily dose of insulin (units) from baseline to 36 weeks
Insulin use will be tracked using bluetooth-enabled insulin pens. The two weeks before a study time point will be treated as representing that study time point.
Time frame: Week 36 after randomization compared with baseline
Change in total daily dose of insulin per kilogram (units/kg) from baseline to 36 weeks
Insulin use will be tracked using bluetooth-enabled insulin pens. The two weeks before a study time point will be treated as representing that study time point.
Time frame: Week 36 after randomization compared with baseline
Change in body weight measured at 36 weeks after randomization
Maintaining or losing weight, rather than gaining, would be considered a positive outcome.
Time frame: Week 36 after randomization compared with baseline
Plan to share: No — IPD cannot be shared due to concerns about participant privacy and confidentiality.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2027, 12 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 12 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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