Personalized Smartphone-assisted Coaching System to Improve Glucose Homeostasis in Adults With Prediabetes - Main Study

NCT03315663 | Withdrawn

• 1 other identifier: IRB00099813
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Prediabetes; Hyperglycemia; Postprandial Hyperglycemia; Impaired Glucose Tolerance; Impaired Fasting Glucose

Keywords

Mobile Health

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 years

Secondary Outcomes (4)

• Evaluation of whether intervention increases physical activity.

  12 months

• Evaluation of whether intervention reduces weight.

  12 months

• Evaluation of whether intervention reduces waist circumference.

  12 months

• Evaluation of whether intervention reduces blood pressure.

  12 months

Study Arms (2)

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).

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.

Other: Sweetch App Alone

Interventions

Sweetch App & DBWS OTHER

Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).

Sweetch App + DBWS

Sweetch App Alone OTHER

Usual care for prediabetes management, Sweetch app alone.

Sweetch App Alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Sweetch Health, Ltd: collaborator

Study Sites (2)

Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

Reading Health System

Reading, Pennsylvania, 19607, United States

Location

MeSH Terms

Conditions

Prediabetic State; Hyperglycemia; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Adrian S. Dobs, MD MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: October 20, 2017
• Study Start: July 1, 2017
• Primary Completion: April 19, 2019
• Study Completion: April 19, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)