Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIaMonD)

Dexcom

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Continuous Glucose Monitor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02282397

PTL-901148

Details and patient eligibility

About

Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood glucose (SMBG) testing, who are not at target glycemic control.

Full description

The study design includes two cohorts that will be treated separately. Phase 1 will include two diabetes cohorts (Type 1 diabetes mellitus and Type 2 diabetes mellitus) who will be randomized independently into two groups, Group 1-CGM and Group 2-SMBG.

The Group-1 CGM cohort who have Type 1 diabetes mellitus will be eligible for Phase 2. Phase 2 will include a separate independent randomization of either MDI therapy (Group 1a- CGM/MDI) or CSII therapy (Group 1b-CGM/CSII).

Additional assessments will be made to evaluate the incremental benefits of changing the insulin delivery method from MDI to CSII in patients already using CGM.

Cost effectiveness and quality of life will be measured between the two groups in each phase.

Enrollment: 316 patients

Sex: All

Ages: 25+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 25 years or older
• Diagnosis of Type 1 diabetes mellitus or insulin-requiring Type 2 diabetes mellitus
• Followed regularly by a physician or diabetes educator
• Using multiple daily injections
• stable control of diabetes
• willing to wear a device such as pump or continuous glucose monitor

Exclusion criteria

• recent or planned use of non-insulin injectable hypoglycemic agents
• Pregnancy or planning to become pregnant during the study
• Medical conditions that make it inappropriate or unsafe to target an A1C of <7%
• Renal disease with Glomerular Filtration Rate <45
• Extensive skin changes/disease that precludes wearing the sensor on normal skin
• Known allergy to medical-grade adhesives
• Recent hospitalization or emergency room visit in the 6 months prior to screening resulting in primary diagnosis of uncontrolled diabetes

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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316 participants in 4 patient groups

Phase 1: SMBG

No Intervention group

Description:

Type 1 or Type 2 diabetes mellitus subjects using SMBG testing and usual care for diabetes management. No intervention to be administered

Phase 1: CGM

Other group

Description:

Type 1 or Type 2 diabetes mellitus subjects using RT-CGM and SMBG testing for diabetes management. RT-CGM (Continuous Glucose Monitoring) is the intervention.

Treatment:

Device: Continuous Glucose Monitor

Phase 2: CGM/MDI

No Intervention group

Description:

Type 1 Diabetes Mellitus subjects using RT-CGM and injections for diabetes management.

Phase 2: CGM/CSII

No Intervention group

Description:

Type 1 Diabetes Mellitus subjects using RT-CGM and CSII for diabetes management.