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.

PROSPECTIVE COHORT STUDY OF FACTORS INFLUENCING GLUCOSE CONTROL AMONG INDIANS WITH TYPE 2 DIABETES

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/02/040619

Enrollment

1550

Registered

2022-02-25

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Inclusion criteria

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

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 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)

Design outcomes

Primary

Measure	Time frame
The primary outcome for the study is postprandial glycemic response (PPGR). 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). Timepoint: Approximately 4 weeks or 29 days	—

Secondary

Measure	Time frame
Not availableTimepoint: Not available	—

Countries

India

Contacts

Public ContactJaganath Swamy

Deciphering Health India Private Limited

science@decipherhealth.com9711197847

Outcome results