Type 1 Diabetes MellitusWISDMNCT03240432
Wireless Innovation for Seniors With Diabetes Mellitus
A study testing Dexcom CGM in people with Type 1 Diabetes Mellitus, run by Jaeb Center for Health Research at 22 sites in United States.
Trial summary
The primary objective of the study is to determine if CGM can reduce hypoglycemia and improve quality of life in older adults with T1D. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Dexcom CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 22 sitesUnited States
- Study dates
- 26 Sep 2017to 10 Sep 2019
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for the study, all participants must meet the following criteria:
- Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the investigator and meeting at least one of the following criteria:
- Age > 6 months and < 10 years old at diagnosis OR ii. Positive pancreatic autoantibodies at any time (GAD-65, IA-2, ICA or ZnT8) or positive anti-insulin autoantibody at diagnosis only (within 10 days of starting insulin) OR iii. Presence of 2 or more of the following clinical indicators suggestive of type 1 diabetes:
- Age at diagnosis < 40 years
- Non-obese at diagnosis according to BMI (< 95th percentile pediatric and < 30 kg/m2 adult)
- Diabetic ketoacidosis (DKA) at any time,
Show all 15Show fewer
- Plasma C-peptide level < 0.8 ng/ml (with blood glucose > 80 mg/dL if available) at any time
- Family history of type 1 diabetes in a first degree relative (parent, sibling, or child).
- Age ≥60 years
- HbA1c <10.0% at screening or within 30 days prior to screening visit (the upper limit was selected as a surrogate measure of likelihood of adherence to the protocol with the belief that those with higher HbA1c levels are generally noncompliant with diabetes management and thus not good candidates for the trial)
- Insulin regimen involves either use of an insulin pump (a minimum of 40% of study population) or multiple daily injections of insulin (minimum of 40% of study population).
- Participant is able to manage his/her diabetes with respect to insulin administration and glucose monitoring (which may include assistance from spouse or other caregiver)
- Participant understands the study protocol and agrees to comply with it
- Participant comprehends written and spoken English
- At least 240 hours (10 out of 14 days) of sensor glucose data with appropriate number of calibrations from the blinded CGM pre-randomization phase
Who cannot join
- Individuals meeting any of the following exclusion criteria at baseline will be excluded from study participation.
- Use of unblinded CGM, outside of a research study, as part of real-time diabetes management in the last 3 months
- At least 10% of time spent with sensor glucose levels < 54 mg/dl during the blinded CGM screening period AND a severe hypoglycemic event in the past 6 months (a severe hypoglycemic event that required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions (see section 8.1).
- Extreme visual or hearing impairment that would impair ability to use real-time CGM assessed at screening visit
- Known adhesive allergy or skin reaction during the blinded CGM pre-randomization phase that would preclude participation in the randomized trial
- Plans to begin non-insulin medication for blood glucose lowering during the course of the study
Show all 13Show fewer
- Stage 4 or 5 renal disease or most recent GFR < 30 ml/min/m2 from local lab within the past 6 months
- The presence of a significant medical or psychiatric condition or use of a medication that in the judgment of the investigator may affect completion of any aspect of the protocol, or is likely to be associated with life expectancy of <1 year.
- Clinical diagnosis of dementia (cognitive impairment that is mild and not considered sufficient for diagnosis of dementia is acceptable)
- Need for use of acetaminophen or acetaminophen-containing products on a regular basis during the 6 months of the trial (unless stipulation no longer required with use of newer generation sensors)
- Inpatient psychiatric treatment in the past 6 months
- Participation in an intervention study (including psychological studies) in past 6 weeks.
- Expectation that participant will be moving out of the area of the clinical center during the next 6 months, unless the move will be to an area served by another study center.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
University of Michigan
Ann Arbor, Michigan, 48105
Atlanta Diabetes Associates
Atlanta, Georgia, 30318
University of Colorado - Barbara Davis Center
Aurora, Colorado, 80045
University of Southern California
Beverly Hills, California, 90211
University of North Carolina
Chapel Hill, North Carolina, 27517
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Henry Ford Health System
Detroit, Michigan, 48202
Scripps Whittier Diabetes Institute
La Jolla, California, 92037
University of Miami
Miami, Florida, 33136
International Diabetes Center
Minneapolis, Minnesota, 55416
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University - Naomi Berrie Diabetes Center
New York, New York, 10032
Florida Hospital Diabetes Institute
Orlando, Florida, 32804
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of Washington Diabetes Care Center
Seattle, Washington, 98105
Washington University
St Louis, Missouri, 63110
SUNY Upstate Medical University
Syracuse, New York, 13210
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: Wireless Innovation for Seniors With Diabetes Mellitus (WISDM)
The primary objective of the study is to determine if CGM can reduce hypoglycemia and improve quality of life in older adults with T1D.
Read the detailed description
Reducing hypoglycemia is an important aspect of management of T1D in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. CGM offers the opportunity to reduce hypoglycemia and its related complications such as fractures from falls and hospitalizations and improve quality of life including reducing hypoglycemic fear and diabetes distress. Despite these potential benefits, CGM is used by only a small proportion of older adults with T1D. Previous studies assessing CGM efficacy have included only a small number of adults ≥ 60 years of age, excluded patients most prone to severe hypoglycemia, focused on improving HbA1c rather than hypoglycemia, and used older generation CGM sensors. These studies are not generalizable to the population of older adults with T1D. The potential benefit of CGM in reducing hypoglycemia in the older adult population has not been well studied. The goal of this study is to assess the potential benefits and risks of CGM in older adults with T1D.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Dexcom CGM
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom CGMDevice
CGM group will be instructed on how to utilize the CGM data for diabetes management. Participants will be encouraged to use CGM values for making diabetes management decisions and will be provided guidelines for when to confirm with a study BGM fingerstick.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitor group | Active comparator | CGM group participants will be asked to use a Dexcom CGM sensor on a daily basis, inserting a new sensor as needed. Participants will be instructed to use the sensor according to FDA labeling. In addition, participants will be advised to check the blood glucose when symptoms or expectations do not match the CGM reading. Participants will have clinic visits at 10 days, 4 weeks, 8 weeks, 16 weeks, and 26 weeks. Receives: Device: Dexcom CGM |
| Blood Glucose Meter group | No intervention | BGM group participants will be asked to use a study blood glucose meter with test strips for a fingerstick blood glucose check with a recommendation of 4 times a day. Participants will be permitted to check a fingerstick glucose as many times a day as they choose. Participants will have a phone visits at 10 days and clinic visits at 4 weeks, 8 weeks, 16 weeks, and 26 weeks. In addition to the in-clinic study visits, the BGM group will have blinded sensor placement visits one week prior to each of the 8, 16, and 26 week visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent with glucose level <70 mg/dL
The primary outcome will be a treatment group comparison of the percentage of sensor values in the hypoglycemic range (<70 mg/dL), adjusted for the baseline values and factors used to stratify randomization in a regression model. Residual values will be examined for an approximate normal distribution. If values are highly skewed, then a transformation or non-parametric methods will be used instead. The BGM Group will be wearing a blinded CGM for one week at 3 time points in the study (in addition to baseline). For analysis, sensor data from the CGM Group will be used from these same time periods to match up with the blinded CGM placed for the BGM Group. The CGM data will be pooled across each time point of CGM data collection for the primary analysis.
Measured: 6 months (26 weeks) from baseline
Secondary outcomes (10)
Change in HbA1c
Mean ± SD values for the change in HbA1c from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be computed for each randomization group and compared in a regression model adjusted for baseline level and factors used to stratify randomization.
Measured: 6 months (26 weeks) from baseline
Change in QOL: Preferring Hypoglycemia Scale
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Measured: 6 months (26 weeks) from baseline
Change in QOL: Blood glucose Monitoring Satisfaction Questionnaire
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Measured: 6 months (26 weeks) from baseline
Change in QOL: Hypoglycemia Fear Survey
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Measured: 6 months (26 weeks) from baseline
Change in QOL: Diabetes Distress Questionnaire
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Measured: 6 months (26 weeks) from baseline
Change in QOL: PROMIS Measures for QOL
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Measured: 6 months (26 weeks) from baseline
Change in QOL: NIH Cognitive Toolbox
Mean ± SD values for the change in total score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Measured: 6 months (26 weeks) from baseline
Change in QOL: NIH Emotions Toolbox
Mean ± SD values for the change in total and composite score from baseline to 26-weeks with 95% confidence intervals or percentiles appropriate to the distribution will be reported for each randomization group, and compared in linear regression models adjusted for baseline level and factors used to stratify randomization.
Measured: 6 months (26 weeks) from baseline
Time spent with glucose level <60 mg/dL
Analyses will be similar to the primary objective.
Measured: 6 months (26 weeks) from baseline
Time spent with glucose level <54 mg/dL
Analyses will be similar to the primary objective.
Measured: 6 months (26 weeks) from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start26 Sep 2017
- Primary completion6 Jun 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Kellee Miller, Principal investigator, Jaeb Center for Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240432
- Sponsor's protocol ID
- WISDM
- Acronym
- WISDM
- Status last verified
- Sep 2019
- First submitted
- 26 Jul 2017
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Miller KM, Kanapka LG, Rickels MR, Ahmann AJ, Aleppo G, Ang L, Bhargava A, Bode BW, Carlson A, Chaytor NS, Gannon G, Goland R, Hirsch IB, Kiblinger L, Kruger D, Kudva YC, Levy CJ, McGill JB, O'Malley G, Peters AL, Philipson LH, Philis-Tsimikas A, Pop-Busui R, Salam M, Shah VN, Thompson MJ, Vendrame F, Verdejo A, Weinstock RS, Young L, Pratley R. Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Jun;24(6):424-434. doi: 10.1089/dia.2021.0503. Epub 2022 Apr 11.
PubMed 35294272Pratley RE, Kanapka LG, Rickels MR, Ahmann A, Aleppo G, Beck R, Bhargava A, Bode BW, Carlson A, Chaytor NS, Fox DS, Goland R, Hirsch IB, Kruger D, Kudva YC, Levy C, McGill JB, Peters A, Philipson L, Philis-Tsimikas A, Pop-Busui R, Shah VN, Thompson M, Vendrame F, Verdejo A, Weinstock RS, Young L, Miller KM; Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2397-2406. doi: 10.1001/jama.2020.6928.
PubMed 32543682
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wireless Innovation for Seniors With Diabetes Mellitus (WISDM)
- ClinicalTrials.gov ID
- NCT03240432
- Acronym / sponsor ID
- WISDM / WISDM
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust, Juvenile Diabetes Research Foundation
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to determine if CGM can reduce hypoglycemia and improve quality of life in older adults with T1D.
Detailed description
Reducing hypoglycemia is an important aspect of management of T1D in older adults, many of whom have hypoglycemic unawareness, cognitive impairment, or both. CGM offers the opportunity to reduce hypoglycemia and its related complications such as fractures from falls and hospitalizations and improve quality of life including reducing hypoglycemic fear and diabetes distress. Despite these potential benefits, CGM is used by only a small proportion of older adults with T1D. Previous studies assessing CGM efficacy have included only a small number of adults ≥ 60 years of age, excluded patients most prone to severe hypoglycemia, focused on improving HbA1c rather than hypoglycemia, and used older generation CGM sensors. These studies are not generalizable to the population of older adults with T1D. The potential benefit of CGM in reducing hypoglycemia in the older adult population has not been well studied. The goal of this study is to assess the potential benefits and risks of CGM in older adults with T1D.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitor group | Active comparator | Device: Dexcom CGMCGM group participants will be asked to use a Dexcom CGM sensor on a daily basis, inserting a new sensor as needed. Participants will be instructed to use the sensor according to FDA labeling. In addition, participants will be advised to check the blood glucose when symptoms or expectations do not match the CGM reading. Participants will have clinic visits at 10 days, 4 weeks, 8 weeks, 16 weeks, and 26 weeks. |
| Blood Glucose Meter group | No intervention | –BGM group participants will be asked to use a study blood glucose meter with test strips for a fingerstick blood glucose check with a recommendation of 4 times a day. Participants will be permitted to check a fingerstick glucose as many times a day as they choose. Participants will have a phone visits at 10 days and clinic visits at 4 weeks, 8 weeks, 16 weeks, and 26 weeks. In addition to the in-clinic study visits, the BGM group will have blinded sensor placement visits one week prior to each of the 8, 16, and 26 week visits. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Clinical diagnosis of insulin dependent presumed autoimmune type 1 diabetes by the investigator and meeting at least one of the following criteria:
- Age ≥60 years
- HbA1c <10.0% at screening or within 30 days prior to screening visit (the upper limit was selected as a surrogate measure of likelihood of adherence to the protocol with the belief that those with higher HbA1c levels are generally noncompliant with diabetes management and thus not good candidates for the trial)
- Insulin regimen involves either use of an insulin pump (a minimum of 40% of study population) or multiple daily injections of insulin (minimum of 40% of study population).
- Participant is able to manage his/her diabetes with respect to insulin administration and glucose monitoring (which may include assistance from spouse or other caregiver)
Key exclusion criteria (13 listed)
- Individuals meeting any of the following exclusion criteria at baseline will be excluded from study participation.
- Use of unblinded CGM, outside of a research study, as part of real-time diabetes management in the last 3 months
- At least 10% of time spent with sensor glucose levels < 54 mg/dl during the blinded CGM screening period AND a severe hypoglycemic event in the past 6 months (a severe hypoglycemic event that required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions (see section 8.1).
- Extreme visual or hearing impairment that would impair ability to use real-time CGM assessed at screening visit
- Known adhesive allergy or skin reaction during the blinded CGM pre-randomization phase that would preclude participation in the randomized trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexcom CGMCGM group will be instructed on how to utilize the CGM data for diabetes management. Participants will be encouraged to use CGM values for making diabetes management decisions and will be provided guidelines for when to confirm with a study BGM fingerstick. | Device | Continuous Glucose Monitor group |
Primary outcome
Time spent with glucose level <70 mg/dL
Time frame: 6 months (26 weeks) from baseline
The primary outcome will be a treatment group comparison of the percentage of sensor values in the hypoglycemic range (<70 mg/dL), adjusted for the baseline values and factors used to stratify randomization in a regression model. Residual values will be examined for an approximate normal distribution. If values are highly skewed, then a transformation or non-parametric methods will be used instead. The BGM Group will be wearing a blinded CGM for one week at 3 time points in the study (in addition to baseline). For analysis, sensor data from the CGM Group will be used from these same time periods to match up with the blinded CGM placed for the BGM Group. The CGM data will be pooled across each time point of CGM data collection for the primary analysis.
10 secondary outcomes
Change in HbA1c
Time frame: 6 months (26 weeks) from baseline
Change in QOL: Preferring Hypoglycemia Scale
Time frame: 6 months (26 weeks) from baseline
Change in QOL: Blood glucose Monitoring Satisfaction Questionnaire
Time frame: 6 months (26 weeks) from baseline
Change in QOL: Hypoglycemia Fear Survey
Time frame: 6 months (26 weeks) from baseline
Change in QOL: Diabetes Distress Questionnaire
Time frame: 6 months (26 weeks) from baseline
Change in QOL: PROMIS Measures for QOL
Time frame: 6 months (26 weeks) from baseline
Change in QOL: NIH Cognitive Toolbox
Time frame: 6 months (26 weeks) from baseline
Change in QOL: NIH Emotions Toolbox
Time frame: 6 months (26 weeks) from baseline
Time spent with glucose level <60 mg/dL
Time frame: 6 months (26 weeks) from baseline
Time spent with glucose level <54 mg/dL
Time frame: 6 months (26 weeks) from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
- Derived from this study: PubMed 35294272Miller KM, Kanapka LG, Rickels MR, Ahmann AJ, Aleppo G, Ang L, Bhargava A, Bode BW, Carlson A, Chaytor NS, Gannon G, Goland R, Hirsch IB, Kiblinger L, Kruger D, Kudva YC, Levy CJ, McGill JB, O'Malley G, Peters AL, Philipson LH, Philis-Tsimikas A, Pop-Busui R, Salam M, Shah VN, Thompson MJ, Vendrame F, Verdejo A, Weinstock RS, Young L, Pratley R. Benefit of Continuous Glucose Monitoring in Reducing Hypoglycemia Is Sustained Through 12 Months of Use Among Older Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Jun;24(6):424-434. doi: 10.1089/dia.2021.0503. Epub 2022 Apr 11.
- Derived from this study: PubMed 32543682Pratley RE, Kanapka LG, Rickels MR, Ahmann A, Aleppo G, Beck R, Bhargava A, Bode BW, Carlson A, Chaytor NS, Fox DS, Goland R, Hirsch IB, Kruger D, Kudva YC, Levy C, McGill JB, Peters A, Philipson L, Philis-Tsimikas A, Pop-Busui R, Shah VN, Thompson M, Vendrame F, Verdejo A, Weinstock RS, Young L, Miller KM; Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group. Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial. JAMA. 2020 Jun 16;323(23):2397-2406. doi: 10.1001/jama.2020.6928.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kellee Miller principal investigator
Jaeb Center for Health Research
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom CGM in people with Type 1 Diabetes Mellitus, run by Jaeb Center for Health Research at 22 sites in United States.
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 15 inclusion and 13 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: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent with glucose level <70 mg/dL (time frame: 6 months (26 weeks) from baseline). 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 NCT03240432, which also lists 2 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 12 Sep 2019.