Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

Diabetes Mellitus Clinical Trial

— DIaMonD  

Official title:

Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282397
• Other study ID #: PTL-901148
• Status: Completed
• Phase: N/A
• First received: October 29, 2014
• Last updated: May 11, 2017
• Start date: September 2014
• Est. completion date: November 2016

Study information

• Verified date: February 2017
• Source: DexCom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Continuous Glucose Monitor
RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.

Locations

Country	Name	City	State
Canada	LMC Clinical Research	Barrie	Ontario
Canada	LMC Clinical Research	Thornhill	Ontario
Canada	LMC Clinical Research	Toronto	Ontario
United States	Albany Medical College	Albany	New York
United States	Amarillo Medical Specialists, LLP	Amarillo	Texas
United States	Mountain Diabetes and Endocrine Center	Asheville	North Carolina
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Laureate Medical Group at Northside, LLC	Atlanta	Georgia
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Research Institute of Dallas	Dallas	Texas
United States	Iowa Diabetes & Endocrinology Research Center	Des Moines	Iowa
United States	Henry Ford Health System	Detroit	Michigan
United States	Marin Endocrine Care & Research	Greenbrae	California
United States	Rocky Mountain Diabetes & Osteoporosis Center	Idaho Falls	Idaho
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	East Coast Institute for Research, LLC	Jacksonville	Florida
United States	Accent Clinical Research	Las Vegas	Nevada
United States	Physicians Research Associates, LLC	Lawrenceville	Georgia
United States	International Diabetes Center	Minneapolis	Minnesota
United States	Advanced Research Associates	Ogden	Utah
United States	Diabetes & Endocrine Associates, PC	Omaha	Nebraska
United States	Legacy Research Institute	Portland	Oregon
United States	Oregon Health & Science University	Portland	Oregon
United States	Granger Medical Clinic	Riverton	Utah
United States	Endocrine Research Solutions	Roswell	Georgia
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Consano Clinical Research	San Antonio	Texas
United States	Diabetes and Glandular Disease	San Antonio	Texas
United States	Coastal Metabolic Research Centre	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
DexCom, Inc.	Jaeb Center for Health Research

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Phase 1 (T1DM) - Post-Hoc CGM Outcomes	Area above curve 70 mg/dL (overall, daytime, and nighttime separately)	6 months
Other	Phase 1 (T1DM) - Post-Hoc CGM Outcomes	Area under curve 180 mg/dL (overall, daytime, and nighttime separately)	6 months
Other	Phase 1 (T2DM) - Post-Hoc A1C Outcome	% of subjects with a reduction in A1C greater than or equal to 0.5%	6 months
Primary	Phase 1 (T1DM) - A1C	Change in A1C from baseline to 24 weeks	6 months
Primary	Phase 1 (T2DM) - A1C	Change in A1C from baseline to 24 weeks	6 months
Primary	Phase 2 (T1DM)	Change in % time in range 70-180 mg/dL from Phase 2 baseline to Phase 2 28 weeks	6 months
Secondary	Phase 1 (T1DM) - A1C Outcomes	% of subjects with A1C less than 7%	6 months
Secondary	Phase 1 (T1DM) - A1C Outcomes	% of subjects with A1C less than 7.5%	6 months
Secondary	Phase 1 (T1DM) - A1C Outcomes	% of subjects with a relative reduction in A1C greater than or equal to 10%	6 months
Secondary	Phase 1 (T1DM) - A1C Outcomes	% of subjects with a reduction in A1C greater than or equal to 1%	6 months
Secondary	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
Secondary	Phase 1 (T1DM) - CGM Outcomes	Mean glucose (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T1DM) - CGM Outcomes	Glucose variability (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T1DM) - CGM Outcomes	% time in range 70-180 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T1DM) - CGM Outcomes	% time less than 70 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T1DM) - CGM Outcomes	% time less than 60 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T1DM) - CGM Outcomes	% time less than 50 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T1DM) - CGM Outcomes	% time greater than 180 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T1DM) - CGM Outcomes	% time greater than 250 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T1DM) - CGM Outcomes	% time greater than 300 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T1DM) - Hypoglycemia Awareness	Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks	6 months
Secondary	Phase 1 (T1DM) - SMBG Outcome	Change in SMBG frequency from baseline to 24 weeks	6 months
Secondary	Phase 1 (T1DM) - QoL Outcomes	Quality of life changes from baseline to 24 weeks	6 months
Secondary	Phase 1 (T1DM) - Cost Effectiveness	Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)	6 months
Secondary	Phase 1 (T1DM) - Adverse Events	Change in the number of SH events from baseline to 24 weeks	6 months
Secondary	Phase 1 (T1DM) - Adverse Events	Change in the number of DKA events from baseline to 24 weeks	6 months
Secondary	Phase 1 (T1DM) - Body Weight	Change in body weight from baseline to 24 weeks	6 months
Secondary	Phase 1 (T1DM) - Insulin Use Outcomes	Change in total daily insulin from baseline to 24 weeks	6 months
Secondary	Phase 1 (T1DM) - Insulin Use Outcomes	Basal to bolus insulin ratio	6 months
Secondary	Phase 1 (T1DM) - Insulin Use Outcomes	Change in the number of boluses/day from baseline to 24 weeks	6 months
Secondary	Phase 1 (T2DM) - A1C Outcomes	% of subjects with A1C less than 7%	6 months
Secondary	Phase 1 (T2DM) - A1C Outcomes	% of subjects with A1C less than 7.5%	6 months
Secondary	Phase 1 (T2DM) - A1C Outcomes	% of subjects with a relative reduction in A1C greater than or equal to 10%	6 months
Secondary	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
Secondary	Phase 1 (T2DM) - A1C Outcomes	% of subjects with a reduction in A1C greater than or equal to 1%	6 months
Secondary	Phase 1 (T2DM) - CGM Outcomes	Mean glucose (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T2DM) - CGM Outcomes	Glucose variability (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T2DM) - CGM Outcomes	% time in range 70-180 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T2DM) - CGM Outcomes	% time less than 70 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T2DM) - CGM Outcomes	% time less than 60 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T2DM) - CGM Outcomes	% time less than 50 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T2DM) - CGM Outcomes	% time greater than 180 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T2DM) - CGM Outcomes	% time greater than 250 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T2DM) - CGM Outcomes	% time greater than 300 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T2DM) - CGM Outcomes	Area above curve 70 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T2DM) - CGM Outcomes	Area under curve 180 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 1 (T2DM) - Hypoglycemia Awareness	Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks	6 months
Secondary	Phase 1 (T2DM) - SMBG	Change in SMBG frequency from baseline to 24 weeks	6 months
Secondary	Phase 1 (T2DM) - QoL Outcomes	Quality of life changes from baseline to 24 weeks	6 months
Secondary	Phase 1 (T2DM) - Cost Effectiveness	Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)	6 months
Secondary	Phase 1 (T2DM) - Adverse Events	Change in the number of SH Events from baseline to 24 weeks	6 months
Secondary	Phase 1 (T2DM) - Adverse Events	Change in the number of DKA Events from baseline to 24 weeks	6 months
Secondary	Phase 1 (T2DM) - Body Weight	Change in body weight from baseline to 24 weeks	6 months
Secondary	Phase 1 (T2DM) - Insulin Use Outcomes	Change in total daily insulin from baseline to 24 weeks	6 months
Secondary	Phase 1 (T2DM) - Insulin Use Outcomes	Basal to bolus insulin ratio	6 months
Secondary	Phase 1 (T2DM) - Insulin Use Outcomes	Change in the number of boluses/day from baseline to 24 weeks	6 months
Secondary	Phase 2 (T1DM) - A1C Outcomes	Change in A1C from Phase 2 baseline to Phase 2 28 weeks	6 months
Secondary	Phase 2 (T1DM) - A1C Outcomes	% of subjects with A1C less than 7%	6 months
Secondary	Phase 2 (T1DM) - A1C Outcomes	% of subjects with A1C less than 7.5%	6 months
Secondary	Phase 2 (T1DM) - A1C Outcomes	% of subjects with a relative reduction in A1C greater than or equal to 10%	6 months
Secondary	Phase 2 (T1DM) - A1C Outcomes	% of subjects with a reduction in A1C greater than or equal to 1%	6 months
Secondary	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
Secondary	Phase 2 (T1DM) - CGM Outcomes	Mean glucose (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 2 (T1DM) - CGM Outcomes	Glucose variability (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 2 (T1DM) - CGM Outcomes	% time less than 70 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 2 (T1DM) - CGM Outcomes	% time less than 60 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 2 (T1DM) - CGM Outcomes	% time less than 50 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 2 (T1DM) - CGM Outcomes	% time greater than 180 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 2 (T1DM) - CGM Outcomes	% time greater than 250 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 2 (T1DM) - CGM Outcomes	% time greater than 300 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 2 (T1DM) - CGM Outcomes	Area above curve 70 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 2 (T1DM) - CGM Outcomes	Area above curve 180 mg/dL (overall, daytime, and nighttime separately)	6 months
Secondary	Phase 2 (T1DM) - Hypoglycemia Awareness	Change in Clarke Hypoglycemia Unawareness score from Phase 2 baseline to Phase 2 28 weeks	6 months
Secondary	Phase 2 (T1DM) - CGM Use	Change in frequency of CGM use from Phase 2 baseline to Phase 2 28 weeks	6 months
Secondary	Phase 2 (T1DM) - SMBG	Change in SMBG frequency from Phase 2 baseline to Phase 2 28 weeks	6 months
Secondary	Phase 2 (T1DM) - QoL Outcomes	Quality of life changes from Phase 2 baseline to Phase 2 28 weeks	6 months
Secondary	Phase 2 (T1DM) - Cost Effectiveness	Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)	6 months
Secondary	Phase 2 (T1DM) - Adverse Events	Change in the number of SH Events from Phase 2 baseline to Phase 2 28 weeks	6 months
Secondary	Phase 2 (T1DM) - Adverse Events	Change in the number of DKA Events from Phase 2 baseline to Phase 2 28 weeks	6 months
Secondary	Phase 2 (T1DM) - Body Weight	Change in body weight from Phase 2 baseline to Phase 2 28 weeks	6 months
Secondary	Phase 2 (T1DM) - Insulin Use Outcomes	Change in total daily insulin from Phase 2 baseline to Phase 2 28 weeks	6 months
Secondary	Phase 2 (T1DM) - Insulin Use Outcomes	Basal to bolus insulin ratio	6 months
Secondary	Phase 2 (T1DM) - Insulin Use Outcomes	Change in the number of boluses/day from Phase 2 baseline to Phase 2 28 weeks	6 months