Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: Continuous Glucose Monitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Phase 1: SMBG<br>Type 1 or Type 2 diabetes mellitus subjects using SMBG testing and usual care for diabetes management. No intervention to be administered | |
| Other: Phase 1: CGM<br>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. | Device: Continuous Glucose Monitor<br>* RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.<br>* Other names: RT-CGM;|
| No Intervention: Phase 2: CGM/MDI<br>Type 1 Diabetes Mellitus subjects using RT-CGM and injections for diabetes management. | |
| No Intervention: Phase 2: CGM/CSII<br>Type 1 Diabetes Mellitus subjects using RT-CGM and CSII for diabetes management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 (T1DM) - A1C | Change in A1C from baseline to 24 weeks | 6 months | 
| Phase 1 (T2DM) - A1C | Change in A1C from baseline to 24 weeks | 6 months | 
| Phase 2 (T1DM) | Change in % time in range 70-180 mg/dL from Phase 2 baseline to Phase 2 28 weeks | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7% | 6 months | 
| Phase 1 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7.5% | 6 months | 
| Phase 1 (T1DM) - A1C Outcomes | % of subjects with a relative reduction in A1C greater than or equal to 10% | 6 months | 
| Phase 1 (T1DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% | 6 months | 
| Phase 1 (T1DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7% | 6 months | 
| Phase 1 (T1DM) - CGM Outcomes | Mean glucose (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T1DM) - CGM Outcomes | Glucose variability (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T1DM) - CGM Outcomes | % time in range 70-180 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T1DM) - CGM Outcomes | % time less than 70 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T1DM) - CGM Outcomes | % time less than 60 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T1DM) - CGM Outcomes | % time less than 50 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T1DM) - CGM Outcomes | % time greater than 180 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T1DM) - CGM Outcomes | % time greater than 250 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T1DM) - CGM Outcomes | % time greater than 300 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T1DM) - Hypoglycemia Awareness | Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks | 6 months | 
| Phase 1 (T1DM) - SMBG Outcome | Change in SMBG frequency from baseline to 24 weeks | 6 months | 
| Phase 1 (T1DM) - QoL Outcomes | Quality of life changes from baseline to 24 weeks | 6 months | 
| Phase 1 (T1DM) - Cost Effectiveness | Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER) | 6 months | 
| Phase 1 (T1DM) - Adverse Events | Change in the number of SH events from baseline to 24 weeks | 6 months | 
| Phase 1 (T1DM) - Adverse Events | Change in the number of DKA events from baseline to 24 weeks | 6 months | 
| Phase 1 (T1DM) - Body Weight | Change in body weight from baseline to 24 weeks | 6 months | 
| Phase 1 (T1DM) - Insulin Use Outcomes | Change in total daily insulin from baseline to 24 weeks | 6 months | 
| Phase 1 (T1DM) - Insulin Use Outcomes | Basal to bolus insulin ratio | 6 months | 
| Phase 1 (T1DM) - Insulin Use Outcomes | Change in the number of boluses/day from baseline to 24 weeks | 6 months | 
| Phase 1 (T2DM) - A1C Outcomes | % of subjects with A1C less than 7% | 6 months | 
| Phase 1 (T2DM) - A1C Outcomes | % of subjects with A1C less than 7.5% | 6 months | 
| Phase 1 (T2DM) - A1C Outcomes | % of subjects with a relative reduction in A1C greater than or equal to 10% | 6 months | 
| Phase 1 (T2DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7% | 6 months | 
| Phase 1 (T2DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% | 6 months | 
| Phase 1 (T2DM) - CGM Outcomes | Mean glucose (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T2DM) - CGM Outcomes | Glucose variability (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T2DM) - CGM Outcomes | % time in range 70-180 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T2DM) - CGM Outcomes | % time less than 70 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T2DM) - CGM Outcomes | % time less than 60 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T2DM) - CGM Outcomes | % time less than 50 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T2DM) - CGM Outcomes | % time greater than 180 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T2DM) - CGM Outcomes | % time greater than 250 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T2DM) - CGM Outcomes | % time greater than 300 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T2DM) - CGM Outcomes | Area above curve 70 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T2DM) - CGM Outcomes | Area under curve 180 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 1 (T2DM) - Hypoglycemia Awareness | Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks | 6 months | 
| Phase 1 (T2DM) - SMBG | Change in SMBG frequency from baseline to 24 weeks | 6 months | 
| Phase 1 (T2DM) - QoL Outcomes | Quality of life changes from baseline to 24 weeks | 6 months | 
| Phase 1 (T2DM) - Cost Effectiveness | Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER) | 6 months | 
| Phase 1 (T2DM) - Adverse Events | Change in the number of SH Events from baseline to 24 weeks | 6 months | 
| Phase 1 (T2DM) - Adverse Events | Change in the number of DKA Events from baseline to 24 weeks | 6 months | 
| Phase 1 (T2DM) - Body Weight | Change in body weight from baseline to 24 weeks | 6 months | 
| Phase 1 (T2DM) - Insulin Use Outcomes | Change in total daily insulin from baseline to 24 weeks | 6 months | 
| Phase 1 (T2DM) - Insulin Use Outcomes | Basal to bolus insulin ratio | 6 months | 
| Phase 1 (T2DM) - Insulin Use Outcomes | Change in the number of boluses/day from baseline to 24 weeks | 6 months | 
| Phase 2 (T1DM) - A1C Outcomes | Change in A1C from Phase 2 baseline to Phase 2 28 weeks | 6 months | 
| Phase 2 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7% | 6 months | 
| Phase 2 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7.5% | 6 months | 
| Phase 2 (T1DM) - A1C Outcomes | % of subjects with a relative reduction in A1C greater than or equal to 10% | 6 months | 
| Phase 2 (T1DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% | 6 months | 
| Phase 2 (T1DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7% | 6 months | 
| Phase 2 (T1DM) - CGM Outcomes | Mean glucose (overall, daytime, and nighttime separately) | 6 months | 
| Phase 2 (T1DM) - CGM Outcomes | Glucose variability (overall, daytime, and nighttime separately) | 6 months | 
| Phase 2 (T1DM) - CGM Outcomes | % time less than 70 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 2 (T1DM) - CGM Outcomes | % time less than 60 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 2 (T1DM) - CGM Outcomes | % time less than 50 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 2 (T1DM) - CGM Outcomes | % time greater than 180 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 2 (T1DM) - CGM Outcomes | % time greater than 250 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 2 (T1DM) - CGM Outcomes | % time greater than 300 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 2 (T1DM) - CGM Outcomes | Area above curve 70 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 2 (T1DM) - CGM Outcomes | Area above curve 180 mg/dL (overall, daytime, and nighttime separately) | 6 months | 
| Phase 2 (T1DM) - Hypoglycemia Awareness | Change in Clarke Hypoglycemia Unawareness score from Phase 2 baseline to Phase 2 28 weeks | 6 months | 
| Phase 2 (T1DM) - CGM Use | Change in frequency of CGM use from Phase 2 baseline to Phase 2 28 weeks | 6 months | 
| Phase 2 (T1DM) - SMBG | Change in SMBG frequency from Phase 2 baseline to Phase 2 28 weeks | 6 months | 
| Phase 2 (T1DM) - QoL Outcomes | Quality of life changes from Phase 2 baseline to Phase 2 28 weeks | 6 months | 
| Phase 2 (T1DM) - Cost Effectiveness | Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER) | 6 months | 
| Phase 2 (T1DM) - Adverse Events | Change in the number of SH Events from Phase 2 baseline to Phase 2 28 weeks | 6 months | 
| Phase 2 (T1DM) - Adverse Events | Change in the number of DKA Events from Phase 2 baseline to Phase 2 28 weeks | 6 months | 
| Phase 2 (T1DM) - Body Weight | Change in body weight from Phase 2 baseline to Phase 2 28 weeks | 6 months | 
| Phase 2 (T1DM) - Insulin Use Outcomes | Change in total daily insulin from Phase 2 baseline to Phase 2 28 weeks | 6 months | 
| Phase 2 (T1DM) - Insulin Use Outcomes | Basal to bolus insulin ratio | 6 months | 
| Phase 2 (T1DM) - Insulin Use Outcomes | Change in the number of boluses/day from Phase 2 baseline to Phase 2 28 weeks | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus