Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus

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.

Norbert Hermanns, Dominic Ehrmann, Lutz Heinemann, Guido Freckmann, Delia Waldenmaier et al. (6 authors)

Diabetes Technology & Therapeutics2022-05-2311 citations

10.1089/dia.2022.0130

The Effect of Reduced Self-Monitored Blood Glucose Testing After Adoption of Continuous Glucose Monitoring on Hemoglobin A1c and Time in RangeData reported previously in Price, DA, et al. (2017). Glycemic impact of reduced frequency of blood glucose monitoring with continuous glucose monitoring use. Diabetes 66(S1):A239.

Sarah Puhr, Peter Calhoun, John Welsh, Tomas C. Walker

Diabetes Technology & Therapeutics2018-07-2313 citations

10.1089/dia.2018.0134

Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial.

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.

2017-08-22477 citations

10.7326/m16-2855

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.

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.

2017-07-1290 citations

10.1016/s2213-8587(17)30217-6

Hypoglycemic Event Frequency and the Effect of Continuous Glucose Monitoring in Adults with Type 1 Diabetes Using Multiple Daily Insulin Injections.

Riddlesworth T, Price D, Cohen N, Beck RW.

2017-06-1451 citations

10.1007/s13300-017-0281-4

Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections

Roy W. Beck, Tonya D. Riddlesworth, Katrina J. Ruedy, Andrew Ahmann, Richard M. Bergenstal et al. (14 authors)

JAMA2017-01-241,114 citations

10.1001/jama.2016.19975

Interventions

DEVICEContinuous Glucose Monitor

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Phase 1 (T2DM) - 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 (T1DM) - A1C	6 months	Change in A1C from baseline to 24 weeks

Secondary

Measure	Time frame	Description
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 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 (T1DM) - Adverse Events	6 months	Change in the number of SH events from baseline to 24 weeks
Phase 1 (T1DM) - Body Weight	6 months	Change in body weight from baseline to 24 weeks
Phase 1 (T1DM) - Insulin Use Outcomes	6 months	Change in total daily insulin from baseline to 24 weeks
Phase 1 (T2DM) - A1C Outcomes	6 months	% of subjects with A1C less than 7%
Phase 1 (T2DM) - CGM Outcomes	6 months	Mean glucose (overall, daytime, and nighttime separately)
Phase 1 (T2DM) - Hypoglycemia Awareness	6 months	Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks
Phase 1 (T2DM) - SMBG	6 months	Change in SMBG frequency from baseline to 24 weeks
Phase 1 (T2DM) - QoL Outcomes	6 months	Quality of life changes from baseline to 24 weeks
Phase 1 (T2DM) - Adverse Events	6 months	Change in the number of SH Events 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 total daily insulin from baseline to 24 weeks
Phase 2 (T1DM) - A1C Outcomes	6 months	Change in A1C from Phase 2 baseline to Phase 2 28 weeks
Phase 2 (T1DM) - CGM Outcomes	6 months	Mean glucose (overall, daytime, and nighttime separately)
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) - CGM Use	6 months	Change in frequency of CGM use from Phase 2 baseline to Phase 2 28 weeks
Phase 2 (T1DM) - SMBG	6 months	Change in SMBG frequency from Phase 2 baseline to Phase 2 28 weeks
Phase 2 (T1DM) - QoL Outcomes	6 months	Quality of life changes 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) - Adverse Events	6 months	Change in the number of SH Events 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 2 (T1DM) - Insulin Use Outcomes	6 months	Change in total daily insulin from Phase 2 baseline to Phase 2 28 weeks
Phase 1 (T2DM) - Cost Effectiveness	6 months	Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER)
Phase 1 (T1DM) - A1C Outcomes	6 months	% of subjects with A1C less than 7%
Phase 1 (T1DM) - CGM Outcomes	6 months	Mean glucose (overall, daytime, and nighttime separately)

Other

Measure	Time frame	Description
Phase 1 (T1DM) - Post-Hoc CGM Outcomes	6 months	Area above curve 70 mg/dL (overall, daytime, and nighttime separately)
Phase 1 (T2DM) - Post-Hoc A1C Outcome	6 months	% of subjects with a reduction in A1C greater than or equal to 0.5%

Countries

Canada, United States

Outcome results

None listed