PrediabetesNCT03315663
Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes - Main Study
A study testing Sweetch App & DBWS and Sweetch App Alone in people with Prediabetes and Hyperglycemia, run by Johns Hopkins University at 2 sites in United States.
Trial summary
Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prediabetes, Hyperglycemia, Postprandial Hyperglycemia
- What is being tested?
- Sweetch App & DBWS and Sweetch App Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2017to 19 Apr 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
- Adults aged 18 -75 years with prediabetes (fasting Blood Glucose (BG) 100-125 mg/dl, A1C 5.7% - 6.4%, or 2 hour BG of 140-199 mg/dl following 75-gram oral glucose tolerance test)
- Body mass index 24 - 40 kg/m2
- English speaker
- Smartphone user (Android or Apple 5s and above)
Who cannot join
- Currently doing more than 150 minutes/week of moderate/vigorous physical activity
- Presence of medical conditions that prevent adoption of moderate physical activity
- Use of any glucose-lowering or weight loss medications within the previous 3 months
- Current pregnancy (self-reported) or planning pregnancy during study period (self-reported)
- Presence of any condition that can result in spurious A1C readings (e.g. anemia [hemoglobin level below lower limit of normal] secondary to iron, vitamin B12, or folate deficiencies; hemoglobinopathies)
- Use of systemic glucocorticoids
Show all 11Show fewer
- Use of antipsychotic medications (stable doses for at least three months of anti-depressants or anti-anxiety drugs will be allowed)
- Severe mental illness or learning disability
- Current participation in another clinical trial
- Liver enzymes >3 x upper limit of normal
- Poor literacy (REALM-R score of 6 or less)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21287
Reading Health System
Reading, Pennsylvania, 19607
About this study
Official title: Effectiveness and Safety of a Smartphone-Assisted Personalized Intervention Program to Reduce Diabetes Risk in Adults With Prediabetes: a Multi-Center, Open-Label Randomized Controlled Trial - Main Study
Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.
Read the detailed description
The mobile phone app Sweetch seeks to increase leisure time physical activity rather than formal exercise through the use of a behavioral analytics engine that continuously process various aspects of the user's life habits, taking into account the user's demographics, behavioral change status, schedule, actual activity patterns, and more. The rationale behind this approach is that long-term adherence and patient engagement are more likely to be achieved when demands on manual user data entry are kept at a minimum. Compared to similar smartphone-assisted prevention apps, there are two novel features of the Sweetch app that may increase its efficacy. First, it uses a "just-in-time" adaptive intervention" approach that tailors recommendations to the user's day-to-day routine and his or her readiness for behavioral change. Second, and most importantly, it requires no direct involvement by the user, since all the necessary data is collected using built-in tracking pedometers, accelerometer and Global Positioning System (GPS) sensors on smartphones. In contrast, interventions that focus on dietary changes (i.e. calorie reduction, change in macronutrient content), require active user tracking at every meal, which is difficult to maintain in the long-term even with the use of sophisticated, electronic calorie counting tools. For these reasons, the Sweetch app may achieve greater long-term adherence, which is usually a limiting factor to efficacy of mobile health interventions.
- Conditions
- Prediabetes, Hyperglycemia, Postprandial Hyperglycemia, Impaired Glucose Tolerance, Impaired Fasting Glucose
- Being tested
- Sweetch App & DBWS, Sweetch App Alone
- Keywords
- Mobile Health
- Medical subject headings
- Prediabetic State, Hyperglycemia, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweetch App & DBWSOther
Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).
Sweetch App AloneOther
Usual care for prediabetes management, Sweetch app alone.
| Study group | Role | What they receive |
|---|---|---|
| Sweetch App + DBWS | Active comparator | Participants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app plus weight monitoring via digital body weight scale (DBWS). Receives: Other: Sweetch App & DBWS |
| Sweetch App Alone | Active comparator | Participants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app alone. Receives: Other: Sweetch App Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Sweetch's PIP compared to usual care to lower A1C
Administration of study intervention will be halted when 3 grade 3 Adverse Events (AEs) determined to be "probably related" are reported to the Data Coordinating Center (DCC). The DCC will notify study sponsor \& investigators immediately when the third grade 3 event is reported \& enrollment screens will stop accepting new study participants. Study sponsor will inform the Data Safety and Monitoring Board (DSMB) members within 24 hours of this occurrence \& will provide DSMB with AE listing reports. The DSMB will convene an ad hoc meeting by teleconference or in writing as soon as possible. The DSMB will provide recommendations for proceeding with the study to study sponsor. If Sweetch Health determines that an unanticipated adverse device effect presents an unreasonable risk to subjects, investigations or parts of investigations presenting that risk will be terminated as soon as possible.
Measured: 2 years
Effectiveness of Sweetch's PIP compared to usual care to lower A1C
A1C is a continuous measure expressed in units of % and mmol/mol. Change in A1C will be calculated by subtracting the 6-month result from the baseline result. The primary effectiveness endpoint will be analyzed using linear regression models, where change in A1C at 6 months will be the dependent variable and treatment group will be the primary predictor variable. The baseline value of the outcome measure will be included as a covariate.
Measured: 2 years
Secondary outcomes (4)
Evaluation of whether intervention increases physical activity.
Through the use of built-in accelerometers and pedometers on smartphones, the study will evaluate the percentage of weekly activity goals (individualized per subject) achieved per subject (range from 60 minutes to 150 minutes per week), proportion of subjects achieving 150 minutes of weekly activity taken as the average of months 4-6 at the 6-month time point, and average of months 7-12 at the 12-month time point. In addition, mean minutes of physical activity per week will be evaluated over intervals between study time points. Physical activity measures will be reported only in the intervention arm, since tracking of physical activity will not be possible in the control arm.
Measured: 12 months
Evaluation of whether intervention reduces weight.
Users update manually or weight data is synced from the digital scale. Data points measured are net weight change from baseline to 6 and 12 months; percentage weight change from baseline to 6 and 12 months; and proportion of subjects achieving 5% body weight loss at 6 and 12 months.
Measured: 12 months
Evaluation of whether intervention reduces waist circumference.
Waist circumference will be measured using a flexible tape measure according to the technique recommended by the American Society for Nutrition. We will evaluate percentage change in waist circumference from baseline to 6 and 12 month time points. The null hypothesis is that there is no difference between percentage change at 6 and 12 months between the intervention and control groups and the alternative hypothesis is that there is a greater percentage change in waist circumference from baseline in the intervention group.
Measured: 12 months
Evaluation of whether intervention reduces blood pressure.
Blood pressure will be measured in accordance with recommendations by the American Heart Association. Changes in systolic and diastolic blood pressure from baseline to 6 and 12 months. Systolic (SBP) and diastolic blood pressure (DBP) will be evaluated as separate continuous measures. The null hypothesis is that changes in SBP and DBP are no different between groups at both time points and the alternative hypothesis is that there is a greater reduction in SBP and DBP in the intervention group. Assuming a variance of 10.1 for change in SBP38 and a change of -1 mmHg in the control arm, the study would have 83% power to detect a between-group difference of 4 mmHg in SBP, which would be considered clinically meaningful. Assuming a variance of 7 for change in DBP and a change of -1 mmHg in the control arm38, the study would have 81% power to detect a between-group difference of 2.7 mmHg in DBP, which would be considered clinically meaningful.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start1 Jul 2017
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
Why it stopped: The study was withdrawn due to budgetary and other constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Model description
- This Pivotal Study will be a multicenter, parallel group, open-label randomized controlled trial with a planned period of 12-month follow-up with the primary effectiveness endpoint assessed at 6 months to compare Sweetch's mHealth Personalized Intervention Program (PIP) to usual care for adults with prediabetes. We intend to enroll 155 subjects in each arm, for a total of 310 subjects in this Study. Subjects will attend a total of 3 visits during the study period with point-of-care measurement of A1C at each study visit (0, 6, and 12 months). A difference in change in A1c of 0.1 between the intervention and control arms and in favor of the intervention arm will be considered clinically meaningful.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Sweetch Health, Ltd
- Responsible party
- Sponsor
- Investigators
- Adrian S. Dobs, MD MHS, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315663
- Sponsor's protocol ID
- IRB00099813
- Status last verified
- May 2019
- First submitted
- 5 Sep 2017
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of a Smartphone-Assisted Personalized Intervention Program to Reduce Diabetes Risk in Adults With Prediabetes: a Multi-Center, Open-Label Randomized Controlled Trial - Main Study
- ClinicalTrials.gov ID
- NCT03315663
- Acronym / sponsor ID
- IRB00099813
- Conditions
- Prediabetes, Hyperglycemia, Postprandial Hyperglycemia, Impaired Glucose Tolerance, Impaired Fasting Glucose
- Keywords
- Mobile Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to budgetary and other constraints.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Sweetch Health, Ltd
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 20 Oct 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.
Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.
Detailed description
The mobile phone app Sweetch seeks to increase leisure time physical activity rather than formal exercise through the use of a behavioral analytics engine that continuously process various aspects of the user's life habits, taking into account the user's demographics, behavioral change status, schedule, actual activity patterns, and more. The rationale behind this approach is that long-term adherence and patient engagement are more likely to be achieved when demands on manual user data entry are kept at a minimum. Compared to similar smartphone-assisted prevention apps, there are two novel features of the Sweetch app that may increase its efficacy. First, it uses a "just-in-time" adaptive intervention" approach that tailors recommendations to the user's day-to-day routine and his or her readiness for behavioral change. Second, and most importantly, it requires no direct involvement by the user, since all the necessary data is collected using built-in tracking pedometers, accelerometer and Global Positioning System (GPS) sensors on smartphones. In contrast, interventions that focus on dietary changes (i.e. calorie reduction, change in macronutrient content), require active user tracking at every meal, which is difficult to maintain in the long-term even with the use of sophisticated, electronic calorie counting tools. For these reasons, the Sweetch app may achieve greater long-term adherence, which is usually a limiting factor to efficacy of mobile health interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This Pivotal Study will be a multicenter, parallel group, open-label randomized controlled trial with a planned period of 12-month follow-up with the primary effectiveness endpoint assessed at 6 months to compare Sweetch's mHealth Personalized Intervention Program (PIP) to usual care for adults with prediabetes. We intend to enroll 155 subjects in each arm, for a total of 310 subjects in this Study. Subjects will attend a total of 3 visits during the study period with point-of-care measurement of A1C at each study visit (0, 6, and 12 months). A difference in change in A1c of 0.1 between the intervention and control arms and in favor of the intervention arm will be considered clinically meaningful.
| Arm | Type | Receives |
|---|---|---|
| Sweetch App + DBWS | Active comparator | Other: Sweetch App & DBWSParticipants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app plus weight monitoring via digital body weight scale (DBWS). |
| Sweetch App Alone | Active comparator | Other: Sweetch App AloneParticipants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app alone. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 -75 years with prediabetes (fasting Blood Glucose (BG) 100-125 mg/dl, A1C 5.7% - 6.4%, or 2 hour BG of 140-199 mg/dl following 75-gram oral glucose tolerance test)
- Body mass index 24 - 40 kg/m2
- English speaker
- Smartphone user (Android or Apple 5s and above)
Key exclusion criteria (11 listed)
- Currently doing more than 150 minutes/week of moderate/vigorous physical activity
- Presence of medical conditions that prevent adoption of moderate physical activity
- Use of any glucose-lowering or weight loss medications within the previous 3 months
- Current pregnancy (self-reported) or planning pregnancy during study period (self-reported)
- Presence of any condition that can result in spurious A1C readings (e.g. anemia [hemoglobin level below lower limit of normal] secondary to iron, vitamin B12, or folate deficiencies; hemoglobinopathies)
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 |
|---|---|---|
| Sweetch App & DBWSUsual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS). | Other | Sweetch App + DBWS |
| Sweetch App AloneUsual care for prediabetes management, Sweetch app alone. | Other | Sweetch App Alone |
Primary outcome
Safety of Sweetch's PIP compared to usual care to lower A1C
Time frame: 2 years
Administration of study intervention will be halted when 3 grade 3 Adverse Events (AEs) determined to be "probably related" are reported to the Data Coordinating Center (DCC). The DCC will notify study sponsor \& investigators immediately when the third grade 3 event is reported \& enrollment screens will stop accepting new study participants. Study sponsor will inform the Data Safety and Monitoring Board (DSMB) members within 24 hours of this occurrence \& will provide DSMB with AE listing reports. The DSMB will convene an ad hoc meeting by teleconference or in writing as soon as possible. The DSMB will provide recommendations for proceeding with the study to study sponsor. If Sweetch Health determines that an unanticipated adverse device effect presents an unreasonable risk to subjects, investigations or parts of investigations presenting that risk will be terminated as soon as possible.
Effectiveness of Sweetch's PIP compared to usual care to lower A1C
Time frame: 2 years
A1C is a continuous measure expressed in units of % and mmol/mol. Change in A1C will be calculated by subtracting the 6-month result from the baseline result. The primary effectiveness endpoint will be analyzed using linear regression models, where change in A1C at 6 months will be the dependent variable and treatment group will be the primary predictor variable. The baseline value of the outcome measure will be included as a covariate.
4 secondary outcomes
Evaluation of whether intervention increases physical activity.
Time frame: 12 months
Evaluation of whether intervention reduces weight.
Time frame: 12 months
Evaluation of whether intervention reduces waist circumference.
Time frame: 12 months
Evaluation of whether intervention reduces blood pressure.
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- 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.
Adrian S. Dobs, MD MHS principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sweetch App & DBWS and Sweetch App Alone in people with Prediabetes and Hyperglycemia, run by Johns Hopkins University at 2 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety of Sweetch's PIP compared to usual care to lower A1C (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2019.