Diabetes Mellitus, Type 2Fit-OneNCT03459573
Fit-One: A Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
A study testing One Drop | Experts On Track, One Drop | Experts On Call and One Drop | Experts Revive in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Chandra Osborn, PhD, MPH at 1 site in United States.
Trial summary
The Fit-One trial involves three prospective, randomized waitlist-controlled studies. These studies evaluate the effects of One Drop's digital therapeutics solution with and without Fitbit devices on the social cognitive, behavioral, and health outcomes of people with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, PreDiabetes
- What is being tested?
- One Drop | Experts On Track, One Drop | Experts On Call and One Drop | Experts Revive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2018to 1 Dec 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years of age
- U.S. residency and mailing address
- Self-reported diagnosis of T1D, T2D, or pre-diabetes
- For people with a diabetes diagnosis, diagnosed for 1+ years
- For people with a diabetes diagnoses, self-reported A1c ≥ 7.0% (later confirmed with a mail-in A1c laboratory test)
- For people with a pre-diabetes diagnoses, self-reported A1c 5.7-6.4% (later confirmed with a mail-in A1c laboratory test)
Show all 15Show fewer
- For people with T2D or pre-diabetes, BMI ≥ 25
- Owns and uses an iPhone or Android phone
- No cardiovascular problems
- No neuromuscular problems
- No orthopedic problems
- Doctor is ok with increased physical activity
- English-speaking
- Naïve to One Drop's digital therapeutics solution
- Naïve to all Fitbit products
Who cannot join
- Currently pregnant or planning to become pregnant during the trial period
- Cannot read or write in English
- Currently in a diabetes education or coaching program
- Previously downloaded the One Drop | Mobile app
- Owns or previously used Fitbit products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fit-One: A Randomized Waitlist Controlled Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
The Fit-One trial involves three prospective, randomized waitlist-controlled studies. These studies evaluate the effects of One Drop's digital therapeutics solution with and without Fitbit devices on the social cognitive, behavioral, and health outcomes of people with diabetes. Fit-One is being tested on adults with type 1 diabetes (T1D) of all weights, and adults with type 2 diabetes (T2D) or pre-diabetes that are overweight or obese (BMI ≥ 25).
Read the detailed description
Sub-study 1 (T2D). Eligible participants (N=300) with T2D, an A1c above 7.0% and Body Mass Index (BMI) ≥ 25 will be randomized to one of three groups. Participants assigned to group 1 (n=100) get One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) and a Fitbit Ionic smartwatch and are asked to use both for 3 months. Participants assigned to group 2 (n=100) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Ionic smartwatch. Finally, participants assigned to group 3 (n=100) are asked to manage their diabetes without an app, coach, or activity tracker for 3 months. After 3 months, group 3 gets One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) and a Fitbit Ionic smartwatch (n=100).
Sub-study 2 (T1D). Eligible participants (N=100) with T1D and an A1c above 7.0% will be randomized to one of two groups. Participants assigned to group 1 (n=50) get One Drop's digital therapeutics solution (app, meter, and 'On Call' in-app coaching) and a Fitbit Ionic smartwatch and are asked to use both for 3 months. Participants assigned to group 2 (n=50) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Ionic smartwatch.
Sub-study 3 (Pre-diabetes). Eligible participants (N=100) with pre-diabetes, an A1c between 5.7-6.4% and a BMI ≥ 25 will be randomized to one of two groups. Participants assigned to group 1 (n=50) get One Drop's digital therapeutics solution ('Revive' in-app coaching) and a Fitbit Charge 2 and are asked to use both for 3 months. Participants assigned to group 2 (n=50) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Charge 2.
- Being tested
- One Drop | Experts On Track, One Drop | Experts On Call, One Drop | Experts Revive
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Drop | Experts On TrackBehavioural
Participants with T2D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months
One Drop | Experts On CallBehavioural
Participants with T1D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months
One Drop | Experts ReviveBehavioural
Participants with pre-diabetes will use One Drop's digital therapeutics solution (app, meter, and 'Revive' in-app coaching) for 3 months
| Study group | Role | What they receive |
|---|---|---|
| T2D: One Drop with Fitbit Ionic | Active comparator | Not described Receives: Behavioral: One Drop | Experts On Track |
| T2D: One Drop without Fitbit Ionic | Active comparator | Not described Receives: Behavioral: One Drop | Experts On Track |
| T2D: Waitlist Control | No intervention | Not described |
| T1D: One Drop with Fitbit Ionic | Active comparator | Not described Receives: Behavioral: One Drop | Experts On Call |
| T1D: One Drop without Fitbit Ionic | Active comparator | Not described Receives: Behavioral: One Drop | Experts On Call |
| PD: One Drop with Fitbit Charge 2 | Active comparator | Not described Receives: Behavioral: One Drop | Experts Revive |
| PD: One Drop without Fitbit Charge 2 | Active comparator | Not described Receives: Behavioral: One Drop | Experts Revive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c
Within- and between-group changes in central lab-assessed A1c measured at baseline and 3 months.
Measured: 3 months
Secondary outcomes (6)
Weight
Within- and between-group changes in self-reported weight measured at baseline and follow-up(s). In sub-study 3, the Fitbit Aria Wi-Fi scale will assess weight at baseline, 4, 8, and 12 months post-baseline.
Measured: 3 months (12 months for Sub-study 3)
Healthcare Utilization
Within- and between-group change in the number of emergency room visits and hospitalizations. This will be assessed with two self-reported items that ask: (1) How many times have you gone to the emergency room in the past 3 months? and (2) How many times have you been admitted to the hospital in the past 3 months?
Measured: 3 months (12 months for Sub-study 3)
Diet
Within- and between-group diet changes. The Summary of Diabetes Self-Care Activities (SDSCA) general and specific diet subscales will measure self-reported 7-day diet behavior at baseline and follow-up(s). The One Drop app will collect daily and weekly diet behavior that's manually entered during the trial period.
Measured: 3 months (12 months for Sub-study 3)
Physical Activity
Within- and between-group activity changes. The SDSCA exercise subscale will measure self-reported 7-day exercise behavior at baseline and follow-up(s). The One Drop app will also collect daily and weekly activity that's manually-entered and/or passively-collected via HealthKit, Google Fit, or a Fitbit tracker or smartwatch during the trial period.
Measured: 3 months (12 months for Sub-study 3)
Medication Adherence
Within- and between-group medication adherence changes. The SDSCA medications subscale will measure self-reported 7-day medication adherence at baseline and follow-up(s). The One Drop app will also collect daily and weekly medication taking that's manually-entered into the app during the trial period.
Measured: 3 months (12 months for Sub-study 3)
Self-Monitoring of Blood Glucose
Within- and between-group self-monitoring of blood glucose (SMBG) changes. The SDSCA SMBG subscale will measure self-reported 7-day SMBG at baseline and follow-up. During the trial period, the One Drop app will collect daily and weekly SMBG that's manually-entered and/or passively-collected via the One Drop | Chrome Bluetooth-connected glucose meter.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start23 Feb 2018
- Primary completion31 Aug 2018
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chandra Osborn, PhD, MPH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Chandra Osborn, PhD, MPH, Informed Data Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459573
- Sponsor's protocol ID
- Fit-One
- Acronym
- Fit-One
- Status last verified
- Aug 2019
- First submitted
- 20 Feb 2018
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herman WH, Rothberg AE. Prevalence of Diabetes in the United States: A Glimmer of Hope? JAMA. 2015 Sep 8;314(10):1005-7. doi: 10.1001/jama.2015.10030. No abstract available.
PubMed 26348749Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
PubMed 11333990Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
PubMed 12453955Marathe PH, Gao HX, Close KL. American Diabetes Association Standards of Medical Care in Diabetes 2017. J Diabetes. 2017 Apr;9(4):320-324. doi: 10.1111/1753-0407.12524. No abstract available.
PubMed 28070960Krass I, Schieback P, Dhippayom T. Adherence to diabetes medication: a systematic review. Diabet Med. 2015 Jun;32(6):725-37. doi: 10.1111/dme.12651. Epub 2015 Jan 9.
PubMed 25440507Green AJ, Bazata DD, Fox KM, Grandy S; SHIELD Study Group. Health-related behaviours of people with diabetes and those with cardiometabolic risk factors: results from SHIELD. Int J Clin Pract. 2007 Nov;61(11):1791-7. doi: 10.1111/j.1742-1241.2007.01588.x. Epub 2007 Sep 20.
PubMed 17887992Peyrot M, Rubin RR, Lauritzen T, Snoek FJ, Matthews DR, Skovlund SE. Psychosocial problems and barriers to improved diabetes management: results of the Cross-National Diabetes Attitudes, Wishes and Needs (DAWN) Study. Diabet Med. 2005 Oct;22(10):1379-85. doi: 10.1111/j.1464-5491.2005.01644.x.
PubMed 16176200Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10.
PubMed 26071863Vangeepuram N, Williams N, Constable J, Waldman L, Lopez-Belin P, Phelps-Waldropt L, Horowitz CR. TEEN HEED: Design of a clinical-community youth diabetes prevention intervention. Contemp Clin Trials. 2017 Jun;57:23-28. doi: 10.1016/j.cct.2017.03.010. Epub 2017 Mar 23. No abstract available.
PubMed 28344183Baye E, Menon K, de Courten MP, Earnest A, Cameron J, de Courten B. Does supplementation with carnosine improve cardiometabolic health and cognitive function in patients with pre-diabetes and type 2 diabetes? study protocol for a randomised, double-blind, placebo-controlled trial. BMJ Open. 2017 Sep 1;7(9):e017691. doi: 10.1136/bmjopen-2017-017691.
PubMed 28864708Coughlin SS, Hatzigeorgiou C, Anglin J, Xie D, Besenyi GM, De Leo G, Stewart J, Wilkins T. Healthy lifestyle intervention for adult clinic patients with type 2 diabetes mellitus. Diabetes Manag (Lond). 2017;7(2):197-204.
PubMed 28794802Gow ML, Baur LA, Johnson NA, Cowell CT, Garnett SP. Reversal of type 2 diabetes in youth who adhere to a very-low-energy diet: a pilot study. Diabetologia. 2017 Mar;60(3):406-415. doi: 10.1007/s00125-016-4163-5. Epub 2016 Nov 26.
PubMed 27889809Diaz KM, Krupka DJ, Chang MJ, Peacock J, Ma Y, Goldsmith J, Schwartz JE, Davidson KW. Fitbit(R): An accurate and reliable device for wireless physical activity tracking. Int J Cardiol. 2015 Apr 15;185:138-40. doi: 10.1016/j.ijcard.2015.03.038. Epub 2015 Mar 4. No abstract available.
PubMed 25795203Osborn CY, Hirsch A, Sears LE, Heyman M, Raymond J, Huddleston B, Dachis J. One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Sep 17;8(9):e16745. doi: 10.2196/16745.
PubMed 32540842
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit-One: A Randomized Waitlist Controlled Trial Evaluating the Effect of One Drop and Fitbit on Diabetes and Pre-diabetes Outcomes
- ClinicalTrials.gov ID
- NCT03459573
- Acronym / sponsor ID
- Fit-One / Fit-One
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chandra Osborn, PhD, MPHIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 9 Mar 2018 (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 Fit-One trial involves three prospective, randomized waitlist-controlled studies. These studies evaluate the effects of One Drop's digital therapeutics solution with and without Fitbit devices on the social cognitive, behavioral, and health outcomes of people with diabetes. Fit-One is being tested on adults with type 1 diabetes (T1D) of all weights, and adults with type 2 diabetes (T2D) or pre-diabetes that are overweight or obese (BMI ≥ 25).
Detailed description
Sub-study 1 (T2D). Eligible participants (N=300) with T2D, an A1c above 7.0% and Body Mass Index (BMI) ≥ 25 will be randomized to one of three groups. Participants assigned to group 1 (n=100) get One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) and a Fitbit Ionic smartwatch and are asked to use both for 3 months. Participants assigned to group 2 (n=100) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Ionic smartwatch. Finally, participants assigned to group 3 (n=100) are asked to manage their diabetes without an app, coach, or activity tracker for 3 months. After 3 months, group 3 gets One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) and a Fitbit Ionic smartwatch (n=100).
Sub-study 2 (T1D). Eligible participants (N=100) with T1D and an A1c above 7.0% will be randomized to one of two groups. Participants assigned to group 1 (n=50) get One Drop's digital therapeutics solution (app, meter, and 'On Call' in-app coaching) and a Fitbit Ionic smartwatch and are asked to use both for 3 months. Participants assigned to group 2 (n=50) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Ionic smartwatch.
Sub-study 3 (Pre-diabetes). Eligible participants (N=100) with pre-diabetes, an A1c between 5.7-6.4% and a BMI ≥ 25 will be randomized to one of two groups. Participants assigned to group 1 (n=50) get One Drop's digital therapeutics solution ('Revive' in-app coaching) and a Fitbit Charge 2 and are asked to use both for 3 months. Participants assigned to group 2 (n=50) get One Drop's digital therapeutics solution and are asked to use it for 3 months. After 3 months, group 2 gets a Fitbit Charge 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| T2D: One Drop with Fitbit Ionic | Active comparator | Behavioral: One Drop | Experts On Track |
| T2D: One Drop without Fitbit Ionic | Active comparator | Behavioral: One Drop | Experts On Track |
| T2D: Waitlist Control | No intervention | – |
| T1D: One Drop with Fitbit Ionic | Active comparator | Behavioral: One Drop | Experts On Call |
| T1D: One Drop without Fitbit Ionic | Active comparator | Behavioral: One Drop | Experts On Call |
| PD: One Drop with Fitbit Charge 2 | Active comparator | Behavioral: One Drop | Experts Revive |
| PD: One Drop without Fitbit Charge 2 | Active comparator | Behavioral: One Drop | Experts Revive |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 18-75 years of age
- U.S. residency and mailing address
- Self-reported diagnosis of T1D, T2D, or pre-diabetes
- For people with a diabetes diagnosis, diagnosed for 1+ years
- For people with a diabetes diagnoses, self-reported A1c ≥ 7.0% (later confirmed with a mail-in A1c laboratory test)
Key exclusion criteria (5 listed)
- Currently pregnant or planning to become pregnant during the trial period
- Cannot read or write in English
- Currently in a diabetes education or coaching program
- Previously downloaded the One Drop | Mobile app
- Owns or previously used Fitbit products
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 |
|---|---|---|
| One Drop | Experts On TrackParticipants with T2D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months | Behavioural | T2D: One Drop with Fitbit Ionic, T2D: One Drop without Fitbit Ionic |
| One Drop | Experts On CallParticipants with T1D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months | Behavioural | T1D: One Drop with Fitbit Ionic, T1D: One Drop without Fitbit Ionic |
| One Drop | Experts ReviveParticipants with pre-diabetes will use One Drop's digital therapeutics solution (app, meter, and 'Revive' in-app coaching) for 3 months | Behavioural | PD: One Drop with Fitbit Charge 2, PD: One Drop without Fitbit Charge 2 |
Primary outcome
Hemoglobin A1c
Time frame: 3 months
Within- and between-group changes in central lab-assessed A1c measured at baseline and 3 months.
6 secondary outcomes
Weight
Time frame: 3 months (12 months for Sub-study 3)
Healthcare Utilization
Time frame: 3 months (12 months for Sub-study 3)
Diet
Time frame: 3 months (12 months for Sub-study 3)
Physical Activity
Time frame: 3 months (12 months for Sub-study 3)
Medication Adherence
Time frame: 3 months (12 months for Sub-study 3)
Self-Monitoring of Blood Glucose
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Background: PubMed 26348749Herman WH, Rothberg AE. Prevalence of Diabetes in the United States: A Glimmer of Hope? JAMA. 2015 Sep 8;314(10):1005-7. doi: 10.1001/jama.2015.10030. No abstract available.
- Background: PubMed 11333990Tuomilehto J, Lindstrom J, Eriksson JG, Valle TT, Hamalainen H, Ilanne-Parikka P, Keinanen-Kiukaanniemi S, Laakso M, Louheranta A, Rastas M, Salminen V, Uusitupa M; Finnish Diabetes Prevention Study Group. Prevention of type 2 diabetes mellitus by changes in lifestyle among subjects with impaired glucose tolerance. N Engl J Med. 2001 May 3;344(18):1343-50. doi: 10.1056/NEJM200105033441801.
- Background: PubMed 12453955Diabetes Prevention Program (DPP) Research Group. The Diabetes Prevention Program (DPP): description of lifestyle intervention. Diabetes Care. 2002 Dec;25(12):2165-71. doi: 10.2337/diacare.25.12.2165.
- Background: PubMed 28070960Marathe PH, Gao HX, Close KL. American Diabetes Association Standards of Medical Care in Diabetes 2017. J Diabetes. 2017 Apr;9(4):320-324. doi: 10.1111/1753-0407.12524. No abstract available.
- Background: PubMed 25440507Krass I, Schieback P, Dhippayom T. Adherence to diabetes medication: a systematic review. Diabet Med. 2015 Jun;32(6):725-37. doi: 10.1111/dme.12651. Epub 2015 Jan 9.
- Background: PubMed 17887992Green AJ, Bazata DD, Fox KM, Grandy S; SHIELD Study Group. Health-related behaviours of people with diabetes and those with cardiometabolic risk factors: results from SHIELD. Int J Clin Pract. 2007 Nov;61(11):1791-7. doi: 10.1111/j.1742-1241.2007.01588.x. Epub 2007 Sep 20.
- Background: PubMed 16176200Peyrot M, Rubin RR, Lauritzen T, Snoek FJ, Matthews DR, Skovlund SE. Psychosocial problems and barriers to improved diabetes management: results of the Cross-National Diabetes Attitudes, Wishes and Needs (DAWN) Study. Diabet Med. 2005 Oct;22(10):1379-85. doi: 10.1111/j.1464-5491.2005.01644.x.
- Background: PubMed 26071863Cadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10.
- Background: PubMed 28344183Vangeepuram N, Williams N, Constable J, Waldman L, Lopez-Belin P, Phelps-Waldropt L, Horowitz CR. TEEN HEED: Design of a clinical-community youth diabetes prevention intervention. Contemp Clin Trials. 2017 Jun;57:23-28. doi: 10.1016/j.cct.2017.03.010. Epub 2017 Mar 23. No abstract available.
- Background: PubMed 28864708Baye E, Menon K, de Courten MP, Earnest A, Cameron J, de Courten B. Does supplementation with carnosine improve cardiometabolic health and cognitive function in patients with pre-diabetes and type 2 diabetes? study protocol for a randomised, double-blind, placebo-controlled trial. BMJ Open. 2017 Sep 1;7(9):e017691. doi: 10.1136/bmjopen-2017-017691.
- Background: PubMed 28794802Coughlin SS, Hatzigeorgiou C, Anglin J, Xie D, Besenyi GM, De Leo G, Stewart J, Wilkins T. Healthy lifestyle intervention for adult clinic patients with type 2 diabetes mellitus. Diabetes Manag (Lond). 2017;7(2):197-204.
- Background: PubMed 27889809Gow ML, Baur LA, Johnson NA, Cowell CT, Garnett SP. Reversal of type 2 diabetes in youth who adhere to a very-low-energy diet: a pilot study. Diabetologia. 2017 Mar;60(3):406-415. doi: 10.1007/s00125-016-4163-5. Epub 2016 Nov 26.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One Drop | Experts On Track, One Drop | Experts On Call and One Drop | Experts Revive in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, run by Chandra Osborn, PhD, MPH at 1 site 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 5 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: status not confirmed, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Hemoglobin A1c (time frame: 3 months). 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 NCT03459573, which also lists 14 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 9 Aug 2019; AzTrials last refreshed its copy on 31 Oct 2026.