A study to assess the relationship between blood glucose control and self-management activities including diet, exercise, sleep, medication consumption and other daily routines for individuals with type 2 diabetes.

Phase 4

Suspended

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2022/02/040619
• Lead Sponsor: Decipher Health Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Age more or equal to 18 and less than 75 years

2.Physician-diagnosed type 2 diabetes treated with not more than or equal to 1 oral hypoglycemic agent concurrent treatment with an injectable non-insulin agent is permitted

3.Hemoglobin A1c HbA1c not more than or equal to 7.0 Percent recorded within the past 30 days.

4. Mobile phone capable of running the protocol-specific applications.

5.Functional English literacy

Exclusion Criteria

1.Unable or unwilling to provide informed consent

2.Unable operate or use the protocol-specified devices and applications or to comply with the study-specified procedures (including food allergies)

3. Unable to fast from midnight the night before the initial study visit

4. Current use of prandial insulin including a continuous insulin infusion pump (basil insulin use alone is permitted)

5. Currently pregnant or planning to become pregnant

6.Estimated life expectancy <= 12 months

7. Active cancer

8. Myocardial infarction or stroke in the last 6 months

9. Receiving or planned to initiate dialysis for end-stage renal disease

10. Receiving oral or intravenous steroids

11. Any contraindication to using a continuous glucose monitor (CGM)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome for the study is postprandial glycemic response (PPGR). <br/ ><br>Following the Wolever and Jenkins method and logged mealtimes and continuous glucose measurements will be used to calculate the incremental area under the curve (iAUC). <br/ ><br>Timepoint: Approximately 4 weeks or 29 days

Secondary Outcome Measures

Name	Time	Method
ot availableTimepoint: Not available