Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT02282397
• Lead Sponsor: DexCom, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-04
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Phase 1 (T1DM) - Hypoglycemia Awareness	6 months	Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks
Phase 1 (T1DM) - SMBG Outcome	6 months	Change in SMBG frequency from baseline to 24 weeks
Phase 2 (T1DM) - A1C Outcomes	6 months	% of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7%
Phase 2 (T1DM) - QoL Outcomes	6 months	Quality of life changes from Phase 2 baseline to Phase 2 28 weeks
Phase 2 (T1DM) - Body Weight	6 months	Change in body weight from Phase 2 baseline to Phase 2 28 weeks
Phase 1 (T1DM) - Adverse Events	6 months	Change in the number of DKA events from baseline to 24 weeks
Phase 1 (T1DM) - Body Weight	6 months	Change in body weight from baseline to 24 weeks
Phase 1 (T2DM) - A1C Outcomes	6 months	% of subjects with a reduction in A1C greater than or equal to 1%
Phase 1 (T2DM) - Hypoglycemia Awareness	6 months	Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks
Phase 1 (T2DM) - Cost Effectiveness	6 months	Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
Phase 2 (T1DM) - CGM Outcomes	6 months	Area above curve 180 mg/dL (overall, daytime, and nighttime separately)
Phase 2 (T1DM) - CGM Use	6 months	Change in frequency of CGM use from Phase 2 baseline to Phase 2 28 weeks
Phase 2 (T1DM) - Cost Effectiveness	6 months	Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
Phase 2 (T1DM) - Insulin Use Outcomes	6 months	Change in the number of boluses/day from Phase 2 baseline to Phase 2 28 weeks
Phase 1 (T1DM) - A1C Outcomes	6 months	% of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7%
Phase 1 (T1DM) - QoL Outcomes	6 months	Quality of life changes from baseline to 24 weeks
Phase 1 (T1DM) - Cost Effectiveness	6 months	Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
Phase 1 (T2DM) - CGM Outcomes	6 months	Area under curve 180 mg/dL (overall, daytime, and nighttime separately)
Phase 1 (T2DM) - QoL Outcomes	6 months	Quality of life changes from baseline to 24 weeks
Phase 1 (T2DM) - Body Weight	6 months	Change in body weight from baseline to 24 weeks
Phase 1 (T2DM) - Insulin Use Outcomes	6 months	Change in the number of boluses/day from baseline to 24 weeks
Phase 2 (T1DM) - SMBG	6 months	Change in SMBG frequency from Phase 2 baseline to Phase 2 28 weeks
Phase 1 (T1DM) - CGM Outcomes	6 months	% time greater than 300 mg/dL (overall, daytime, and nighttime separately)
Phase 1 (T2DM) - SMBG	6 months	Change in SMBG frequency from baseline to 24 weeks
Phase 1 (T2DM) - Adverse Events	6 months	Change in the number of DKA Events from baseline to 24 weeks
Phase 2 (T1DM) - Hypoglycemia Awareness	6 months	Change in Clarke Hypoglycemia Unawareness score from Phase 2 baseline to Phase 2 28 weeks
Phase 2 (T1DM) - Adverse Events	6 months	Change in the number of DKA Events from Phase 2 baseline to Phase 2 28 weeks
Phase 1 (T1DM) - Insulin Use Outcomes	6 months	Change in the number of boluses/day from baseline to 24 weeks

Trial Locations

Locations (27)

Marin Endocrine Care & Research; 🇺🇸 Greenbrae, California, United States

Coastal Metabolic Research Centre; 🇺🇸 Ventura, California, United States

East Coast Institute for Research, LLC; 🇺🇸 Jacksonville, Florida, United States

Laureate Medical Group at Northside, LLC; 🇺🇸 Atlanta, Georgia, United States

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States

Columbus Regional Research Institute; 🇺🇸 Columbus, Georgia, United States

Physicians Research Associates, LLC; 🇺🇸 Lawrenceville, Georgia, United States

Endocrine Research Solutions; 🇺🇸 Roswell, Georgia, United States

Rocky Mountain Diabetes & Osteoporosis Center; 🇺🇸 Idaho Falls, Idaho, United States

Iowa Diabetes & Endocrinology Research Center; 🇺🇸 Des Moines, Iowa, United States

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