Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes
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ClinicalTrials.gov Identifier: NCT02896010 |
Recruitment Status :
Completed
First Posted : September 12, 2016
Last Update Posted : March 27, 2018
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Condition or disease | Intervention/treatment | Phase |
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Prediabetes Hyperglycemia Postprandial Hyperglycemia Impaired Glucose Tolerance Impaired Fasting Glucose | Other: Sweetch App + DBWS Other: Sweetch App Alone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 55 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Effectiveness of a Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes: Rationale and Study Protocol - Pilot Study |
Actual Study Start Date : | October 10, 2016 |
Actual Primary Completion Date : | November 17, 2017 |
Actual Study Completion Date : | November 17, 2017 |
Arm | Intervention/treatment |
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Active Comparator: Sweetch App + DBWS
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).
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Other: Sweetch App + DBWS
Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS). |
Active Comparator: Sweetch App Alone
Participants receive usual care for prediabetes management. In addition, participants will be randomized to receive the Sweetch app alone.
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Other: Sweetch App Alone
Usual care for prediabetes management, Sweetch app alone. |
- Yield of Recruitment [ Time Frame: 3 months ]Proportion of recruited participants who enroll and complete the 3 month study
- Engagement [ Time Frame: 3 months ]Proportion of enrolled participants who keep app installed and open in background of their smartphones during duration of the study.
- Usability and Satisfaction [ Time Frame: 3 months ]Usability and Satisfaction will be measured using an adapted Systems Usability Scale, a validated method of measuring usability with a wide array of technological products, including smartphones.
- Adherence to physical activity goal [ Time Frame: 3 months ]Proportion of enrolled participants meeting mean 150 minute per week physical activity target (evaluated at 4 week intervals and over course of entire 12 week study period)

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults aged 18 -75 years with prediabetes (fasting 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)
Exclusion Criteria:
- 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
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02896010
United States, Maryland | |
Johns Hopkins Hospital | |
Baltimore, Maryland, United States, 21287 | |
United States, Pennsylvania | |
Reading Health System | |
Reading, Pennsylvania, United States, 19607 |
Principal Investigator: | Nestoras Mathioudakis, MD MHS | Johns Hopkins University | |
Principal Investigator: | Adrian S Dobs, MD MHS | Johns Hopkins University |
Responsible Party: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT02896010 |
Other Study ID Numbers: |
IRB00099812 |
First Posted: | September 12, 2016 Key Record Dates |
Last Update Posted: | March 27, 2018 |
Last Verified: | March 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Mobile Health |
Hyperglycemia Prediabetic State Glucose Intolerance Glucose Metabolism Disorders |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases |