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Observational Study
. 2022 Feb;39(2):e14739.
doi: 10.1111/dme.14739. Epub 2021 Nov 23.

Non-adjunctive continuous glucose monitoring for control of hypoglycaemia (COACH): Results of a post-approval observational study

Stayce E Beck  1 , Colleen Kelly  2 , David A Price  1 ; COACH Study Group
Collaborators, Affiliations
Observational Study

Non-adjunctive continuous glucose monitoring for control of hypoglycaemia (COACH): Results of a post-approval observational study

Stayce E Beck et al. Diabet Med. 2022 Feb.

Abstract

Objective: Prior to the Continuous Monitoring and Control of Hypoglycaemia (COACH) study described herein, no study had been powered to evaluate the impact of non-adjunctive RT-CGM use on the rate of debilitating moderate or severe hypoglycaemic events.

Research design and methods: In this 12-month observational study, adults with insulin-requiring diabetes who were new to RT-CGM participated in a 6-month control phase where insulin dosing decisions were based on self monitoring of blood glucose values, followed by a 6-month phase where decisions were based on RT-CGM data (i.e. non-adjunctive RT-CGM use); recommendations for RT-CGM use were made according to sites' usual care. The primary outcome was change in debilitating moderate (requiring second-party assistance) and severe (resulting in seizures or loss of consciousness) hypoglycaemic event frequency. Secondary outcomes included changes in HbA1c and diabetic ketoacidosis (DKA) frequency.

Results: A total of 519 participants with mean (SD) age 50.3 (16.1) years and baseline HbA1c 8.0% (1.4%) completed the study, of whom 32.8% had impaired hypoglycaemia awareness and 33.5% had type 2 diabetes (T2D). The mean (SE) per-patient frequency of hypoglycaemic events decreased by 63% from 0.08 (0.016) during the SMBG phase to 0.03 (0.010) during the RT-CGM phase (p = 0.005). HbA1c decreased during the RT-CGM phase both for participants with type 1 diabetes (T1D) and T2D and there was a trend towards larger reductions among individuals with higher baseline HbA1c.

Conclusions: Among adults with insulin-requiring diabetes, non-adjunctive use of RT-CGM data is safe, resulting in significantly fewer debilitating hypoglycaemic events than management using SMBG.

Keywords: COACH; continuous glucose monitoring; severe hypoglycaemia.

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Conflict of interest statement

Drs. Beck and Price are employees and shareholders of Dexcom, Inc. Dr. Kelly has received consulting fees from Dexcom, Inc.

Figures

FIGURE 1
FIGURE 1
Flowchart of COACH study completion. [1] Intent‐to‐treat (ITT) population includes all enrolled patients that meet all inclusion criteria and none of the exclusion criteria. [2] Per‐protocol (PP) population includes all ITT patients that completed the 12‐month follow‐up. [3] Non‐compliant includes: does not want study treatment, poor outcome, visit too lengthy, travel difficulty. [4] Treatment‐related decisions includes: changed doctor, PCP prescribed Dexcom G6 CGM, PCP prescribed other CGM, and other treatment requested. [5] Health‐related decisions includes: AE, developed end‐stage renal disease, poor health. [6] Other includes: moved, finances, other
FIGURE 2
FIGURE 2
(a) Six‐month prevalences of hypoglycaemic events during periods of SMBG and RT‐CGM use in the PP population for participants with T2D (grey bars) or T1D (white bars). (b) Change in HbA1c levels between Month 6 (end of SMBG phase) and Month 12 (end of CGM phase) for participants with T1D (white bars) and T2D (grey bars). Participants were grouped by baseline (Month 0) HbA1c levels
See this image and copyright information in PMC

References

    1. Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non‐insulin‐dependent diabetes mellitus: a randomized prospective 6‐year study. Diabetes Res Clin Pract. 1995;28(2):103‐117. - PubMed
    1. The Diabetes Control and Complications Trial Research Group . The effect of intensive treatment of diabetes on the development and progression of long‐term complications in insulin‐dependent diabetes mellitus. N Engl J Med. 1993;329(14):977‐986. - PubMed
    1. DCCT Research Group . Hypoglycemia in the diabetes control and complications trial. The diabetes control and complications trial research group. Diabetes. 1997;46(2):271‐286. - PubMed
    1. Mathieu C. Minimising hypoglycaemia in the real world: the challenge of insulin. Diabetologia. 2021;64(5):978‐984. - PubMed
    1. Bode BW, Schwartz S, Stubbs HA, Block JE. Glycemic characteristics in continuously monitored patients with type 1 and type 2 diabetes: normative values. Diabetes Care. 2005;28(10):2361‐2366. - PubMed

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