Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

NCT02282397 | Completed

• 1 other identifier: PTL-901148
• Study Type: interventional
• Target: 316
• Locations: 2 countries
• Sites: 30

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (77)

• Phase 1 (T1DM) - A1C Outcomes

  6 months

• Phase 1 (T1DM) - A1C Outcomes

  6 months

• Phase 1 (T1DM) - A1C Outcomes

  6 months

• Phase 1 (T1DM) - A1C Outcomes

  6 months

• Phase 1 (T1DM) - A1C Outcomes

  6 months

Other Outcomes (3)

• Phase 1 (T1DM) - Post-Hoc CGM Outcomes

  6 months

• Phase 1 (T1DM) - Post-Hoc CGM Outcomes

  6 months

• Phase 1 (T2DM) - Post-Hoc A1C Outcome

  6 months

Study Arms (4)

Phase 1: SMBG

NO INTERVENTION

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

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

Phase 2: CGM/MDI

NO INTERVENTION

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

Phase 2: CGM/CSII

NO INTERVENTION

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

Interventions

Continuous Glucose Monitor DEVICE

RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.

Also known as: CGM, RT-CGM

Phase 1: CGM

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• DexCom, Inc.: lead
• Jaeb Center for Health Research: collaborator

Study Sites (30)

Marin Endocrine Care & Research

Greenbrae, California, 94904, United States

Location

Coastal Metabolic Research Centre

Ventura, California, 93003, United States

Location

East Coast Institute for Research, LLC

Jacksonville, Florida, 32204, United States

Location

East Coast Institute for Research, LLC

Jacksonville, Florida, 32216, United States

Location

Laureate Medical Group at Northside, LLC

Atlanta, Georgia, 30308, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Physicians Research Associates, LLC

Lawrenceville, Georgia, 30046, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

Rocky Mountain Diabetes & Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

Iowa Diabetes & Endocrinology Research Center

Des Moines, Iowa, 50314, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Diabetes & Endocrine Associates, PC

Omaha, Nebraska, 68114, United States

Location

Accent Clinical Research

Las Vegas, Nevada, 89106, United States

Location

Albany Medical College

Albany, New York, 12206, United States

Location

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, 28803, United States

Location

Legacy Research Institute

Portland, Oregon, 97225, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Amarillo Medical Specialists, LLP

Amarillo, Texas, 79106, United States

Location

Research Institute of Dallas

Dallas, Texas, 75231, United States

Location

Diabetes and Glandular Disease

San Antonio, Texas, 78229, United States

Location

Consano Clinical Research

San Antonio, Texas, 78258, United States

Location

Advanced Research Associates

Ogden, Utah, 84405, United States

Location

Granger Medical Clinic

Riverton, Utah, 84065, United States

Location

LMC Clinical Research

Barrie, Ontario, L4M 7G1, Canada

Location

LMC Clinical Research

Thornhill, Ontario, L4J 8L7, Canada

Location

LMC Clinical Research

Toronto, Ontario, M4G 3E8, Canada

Location

Related Publications (9)

• Hermanns N, Ehrmann D, Heinemann L, Freckmann G, Waldenmaier D, Calhoun P. Real-Time Continuous Glucose Monitoring Can Predict Severe Hypoglycemia in People with Type 1 Diabetes: Combined Analysis of the HypoDE and DIAMOND Trials. Diabetes Technol Ther. 2022 Sep;24(9):603-610. doi: 10.1089/dia.2022.0130. Epub 2022 Jun 10.

  PMID: 35604794 DERIVED

• Puhr S, Welsh JB, Bauza CE, Walker TC. Patients with Type 2 Diabetes and Residual Insulin Secretory Capacity Realize Glycemic Benefits from Real-Time Continuous Glucose Monitoring. J Diabetes Sci Technol. 2021 Jul;15(4):965-967. doi: 10.1177/19322968211007880. Epub 2021 Apr 15. No abstract available.

  PMID: 33855888 DERIVED

• Calhoun P, Price D, Beck RW. Glycemic Improvement Using Continuous Glucose Monitoring by Baseline Time in Range: Subgroup Analyses from the DIAMOND Type 1 Diabetes Study. Diabetes Technol Ther. 2021 Mar;23(3):230-233. doi: 10.1089/dia.2020.0471. Epub 2020 Oct 20.

  PMID: 33006904 DERIVED

• Puhr S, Calhoun P, Welsh JB, Walker TC. The Effect of Reduced Self-Monitored Blood Glucose Testing After Adoption of Continuous Glucose Monitoring on Hemoglobin A1c and Time in Range. Diabetes Technol Ther. 2018 Aug;20(8):557-560. doi: 10.1089/dia.2018.0134. Epub 2018 Jul 23.

  PMID: 30036082 DERIVED

• Beck RW, Riddlesworth TD, Ruedy K, Ahmann A, Haller S, Kruger D, McGill JB, Polonsky W, Price D, Aronoff S, Aronson R, Toschi E, Kollman C, Bergenstal R; DIAMOND Study Group. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med. 2017 Sep 19;167(6):365-374. doi: 10.7326/M16-2855. Epub 2017 Aug 22.

  PMID: 28828487 DERIVED

• Beck RW, Riddlesworth TD, Ruedy KJ, Kollman C, Ahmann AJ, Bergenstal RM, Bhargava A, Bode BW, Haller S, Kruger DF, McGill JB, Polonsky W, Price D, Toschi E; DIAMOND Study Group. Effect of initiating use of an insulin pump in adults with type 1 diabetes using multiple daily insulin injections and continuous glucose monitoring (DIAMOND): a multicentre, randomised controlled trial. Lancet Diabetes Endocrinol. 2017 Sep;5(9):700-708. doi: 10.1016/S2213-8587(17)30217-6. Epub 2017 Jul 12.

  PMID: 28711468 DERIVED

• Riddlesworth T, Price D, Cohen N, Beck RW. Hypoglycemic Event Frequency and the Effect of Continuous Glucose Monitoring in Adults with Type 1 Diabetes Using Multiple Daily Insulin Injections. Diabetes Ther. 2017 Aug;8(4):947-951. doi: 10.1007/s13300-017-0281-4. Epub 2017 Jun 14.

  PMID: 28616804 DERIVED

• Polonsky WH, Hessler D, Ruedy KJ, Beck RW; DIAMOND Study Group. The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial. Diabetes Care. 2017 Jun;40(6):736-741. doi: 10.2337/dc17-0133. Epub 2017 Apr 7.

  PMID: 28389582 DERIVED

• Beck RW, Riddlesworth T, Ruedy K, Ahmann A, Bergenstal R, Haller S, Kollman C, Kruger D, McGill JB, Polonsky W, Toschi E, Wolpert H, Price D; DIAMOND Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial. JAMA. 2017 Jan 24;317(4):371-378. doi: 10.1001/jama.2016.19975.

  PMID: 28118453 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David Price, MD

  DexCom, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: November 4, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (27)