An interventional study of Dexcom G6 CGM in Type 1 Diabetes Mellitus, MDI and CGM, sponsored by Oregon Health and Science University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-03-18.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Other
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 is the 10th largest by enrollment of the 18 interventional ones that give a count, is one of 2 that started in 2018, is one of 16 with no phase, and was the 7th 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+
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 to 50 Years · 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. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 25 is below 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 goal of this study is to assess the impact of physician-driven insulin setting changes in type 1 patients using multiple daily injection insulin therapy with exercise. This is a short outpatient study with multiple outpatient and home exercise sessions with an assigned type of exercise.
Subjects will be on study for 28 days. Sensor glucose, exercise, insulin and meal data will be collected during this time. Subjects will wear the Dexcom G6 CGM system and a physical activity monitor. The Subjects will complete 2 exercise visits in-clinic and 4 exercise visits as an outpatient. Subjects will be randomized to aerobic, anaerobic or high intensity interval exercise sessions for 30 minutes each. Physicians will review CGM and insulin data every 7 days and make insulin dose recommendations that the subject will adjust in the dose calculator.
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.
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.
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.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
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.
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.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
Subjects in this arm will complete aerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Device: Dexcom G6 CGM
Subjects in this arm will complete anaerobic exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Device: Dexcom G6 CGM
Subjects in this arm will complete high intensity interval exercise at home and at OHSU for the study. Subjects will use a Dexcom G6 CGM.
Device: Dexcom G6 CGM
Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
Percent of Time With Sensed Glucose 70-180 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity. The percent of time with sensed glucose 70-180 mg/dl was averaged across days 1-7.
Time frame: Days 1-7
Percent of Time With Sensed Glucose Less Than 70 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less than 70 mg/dl was averaged across days 1-7.
Time frame: Days 1-7
Percent of Time With Sensed Glucose 70-180 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose 70-180 mg/dl was averaged across days 22-28.
Time frame: Days 22-28
Percent of Time With Sensed Glucose Less Than 70 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 70 mg/dl was averaged across days 22-28.
Time frame: Days 22-28
Percent of Time With Sensed Glucose Less Than 54 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 1-7.
Time frame: Days 1-7
Mean Sensed Glucose
Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 1-7.
Time frame: Days 1-7
Percent of Time With Sensed Glucose Less Than 54 mg/dl
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 22-28.
Time frame: Days 22-28
Mean Sensed Glucose
Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 22-28.
Time frame: Days 22-28
| Milestone | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Started | 8 | 8 | 9 |
| Completed | 8 | 8 | 9 |
| Not completed | 0 | 0 | 0 |
| Milestone | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Started | 8 | 8 | 9 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 |
| Milestone | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Started | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 |
| Milestone | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Started | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 |
| Milestone | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Started | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 |
| Milestone | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Started | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 |
| Milestone | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Started | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 |
| Milestone | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Started | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 |
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity. The percent of time with sensed glucose 70-180 mg/dl was averaged across days 1-7.
| percentage of time | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Percent of Time With Sensed Glucose 70-180 mg/dl | 58.8 ± 18.9 | 51.2 ± 10.8 | 59.3 ± 14.6 |
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less than 70 mg/dl was averaged across days 1-7.
| percentage of time | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Percent of Time With Sensed Glucose Less Than 70 mg/dl | 3.3 ± 3.5 | 2.4 ± 1.4 | 3.3 ± 2.2 |
Assess the percent of time that the Dexcom G6 reported sensor glucose values between 70-180 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose 70-180 mg/dl was averaged across days 22-28.
| percentage of time | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Percent of Time With Sensed Glucose 70-180 mg/dl | 53.6 ± 13.6 | 51.0 ± 16.0 | 50.4 ± 13.4 |
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 70 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 70 mg/dl was averaged across days 22-28.
| percentage of time | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Percent of Time With Sensed Glucose Less Than 70 mg/dl | 3.8 ± 3.4 | 2.2 ± 2.4 | 3.1 ± 4.0 |
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 1-7.
| percentage of time | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Percent of Time With Sensed Glucose Less Than 54 mg/dl | 0.5 ± 0.8 | 0.4 ± 0.3 | 0.5 ± 0.4 |
Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 1-7.
| mg/dl | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Mean Sensed Glucose | 168.4 ± 28.7 | 177.7 ± 14.5 | 166.4 ± 25.7 |
Assess the percent of time that the Dexcom G6 reported sensor glucose values less than 54 mg/dl using values uploaded to Dexcom Clarity.The percent of time with sensed glucose less then 54 mg/dl was averaged across days 22-28.
| percentage of time | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Percent of Time With Sensed Glucose Less Than 54 mg/dl | 0.7 ± 0.8 | 0.5 ± 1.1 | 0.8 ± 1.2 |
Assess the mean Dexcom G6 reported sensor glucose values using values uploaded to Dexcom Clarity.The mean sensed glucose was averaged across days 22-28.
| mg/dl | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| Mean Sensed Glucose | 174.0 ± 22.1 | 184.1 ± 25.2 | 183.0 ± 33.1 |
Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aerobic Exercise | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| Anaerobic Exercise | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| High Intensity Interval Exercise | 0/9 (0%) | 0/9 (0%) | 3/9 (33.3%) |
| Event | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise |
|---|---|---|---|
| redness and swelling at sensor siteSkin and subcutaneous tissue disorders | 1/8 | 0/8 | 0/9 |
| upper respiratory infectionInfections and infestations | 1/8 | 0/8 | 1/9 |
| Shoulder injuryMusculoskeletal and connective tissue disorders | 0/8 | 0/8 | 1/9 |
| lightheadednessVascular disorders | 0/8 | 0/8 | 1/9 |
| Age, Categorical(Participants) | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 8 | 9 | 25 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise | Total |
|---|---|---|---|---|
| Mean | 31.8 ± 6.7 | 28.6 ± 6.0 | 29 ± 5.3 | 29.8 ± 5.9 |
| Sex: Female, Male(Participants) | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise | Total |
|---|---|---|---|---|
| Female | 4 | 5 | 6 | 15 |
| Male | 4 | 3 | 3 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 8 | 8 | 9 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 1 | 4 |
| White | 7 | 4 | 8 | 19 |
| More than one race | 0 | 2 | 0 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Aerobic Exercise | Anaerobic Exercise | High Intensity Interval Exercise | Total |
|---|---|---|---|---|
| United States | 8 | 8 | 9 | 25 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jul 2018 to primary completion in May 2019, 9 months.
Results were first posted in Mar 2020, 10 months after primary completion.
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 9 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.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Oregon Health and Science University →