An interventional study of Sweetch App & DBWS and Sweetch App Alone in Prediabetes, Hyperglycemia and Postprandial Hyperglycemia, sponsored by Johns Hopkins University. Withdrawn at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-05-16.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Supportive care
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Among 12 studies in Prediabetic State by Johns Hopkins University — 4 open to participants now, 4 under way, none of them phase 3. Prediabetic State · Johns Hopkins University.
Among the 12 studies in Prediabetic State by Johns Hopkins University, this one is the 12th largest by enrollment, is the only one that started in 2017, is one of 11 with no phase, and was the 3rd registered.
918 studies on the registry are indexed under Prediabetic State; 231 are open to participants now.
Browse Prediabetic State studies →4 of the 12 studies in Prediabetic State by Johns Hopkins University are open now, in 1 country. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 18–75
Johns Hopkins University · Sites in United States
Ages 18–23 · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 18–50 · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 25–75 · Healthy volunteers
By country, each count listing its studies:
Of the 144 Prediabetic State studies recruiting now, 51 (35%) set no upper age limit and 83 (58%) stop at 75 or younger; 12 take children under 18; 54 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2017.
Median enrollment 65 across the 12 interventional studies. Of the 7 that completed or were terminated, 4 (57%) have results posted.
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Johns Hopkins University is the lead sponsor of 1,816 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
2 of the studies in Prediabetic State by Johns Hopkins 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 |
|---|---|
| NCT06358261Johns Hopkins UniversityStudy of a Diabetes Prevention Patient Activation Clinical Decision Support Tool | 2027-01-01 |
| NCT07553325Johns Hopkins UniversityRisk-informed Shared-decision Making Engagement Strategy for Patients With Prediabetes | 2027-09-01 |
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Among the 12 studies in Prediabetic State by Johns Hopkins University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Sweetch is a personalized mobile-health platform coaching system (mobile phone app) designed to promote adherence to physical activity guidelines for people with prediabetes.
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: Sweetch App & DBWS
Participants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app alone.
Other: Sweetch App Alone
Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).
Usual care for prediabetes management, Sweetch app alone.
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.
Time frame: 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.
Time frame: 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Apr 2019, 21 months.
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This study is withdrawn, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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